[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"RAI Services Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,69,91,110,128,146],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645037","a-consumer-use-behavior-study-to-measure-the-puffing-topography-of-heated-tobacco-products-100645037",false,"NCT07677280","A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products","A Consumer Use Behavior Study to Measure the Puffing Topography of Heated Tobacco Products (Glo and Glo Plus)","Inclusion Criteria:\n\n* Ability to read, understand, and be willing to sign an ICF and complete questionnaires written in English.\n* Generally healthy male or female, between age 21-65 years (inclusive at the time of consent), verified with government-issued identification.\n* All female (assigned at birth) candidate participants and those who identify as \"intersex\" or \"unknown\" during screening who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.\n* Self-report currently smoking at least five CPD on smoking days in the past 30 days.\n* Smoke CC on at least 27 days out of last 30 days.\n* Have smoked at least 100 factory-made filtered CC in their lifetime prior to SEV.\n* Indicate a willingness to use an HTP.\n* Agree to participate in the study and to abide by the study restrictions and requirements, including the use of the assigned Study IP, as described in the ICF.\n* Agree not to allow any other person to use any product provided to them for use during this study.\n\nExclusion Criteria:\n\n* Female participants who self-report they are pregnant or breastfeeding or could become pregnant or start breastfeeding in the next 6 months from the study start date.\n* Women who self-report they are not intending to use adequate contraception methods to prevent pregnancy.\n\n  a) Examples of acceptable contraception methods are, but not limited to: i. Surgical sterilization (hysterectomy, bilateral tubal ligation\u002Focclusion, bilateral oophorectomy, bilateral salpingectomy); ii. Established use of oral, implantable, injectable, or transdermal methods of contraception associated with inhibition of ovulation; iii. Physical barrier method (e.g., condom, diaphragm\u002Fsponge\u002Fcervical cap) with spermicide; iv. Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena); v. Vasectomized partner; vi. Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the purpose of study participation); and vii. Post-menopausal who are not on hormone replacement therapy.\n* Males who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or to refrain from donating sperm from the time of signing the informed consent until the EOS, unless they have undergone a vasectomy or were abstinent from heterosexual intercourse, or their female partner was not able to bear children.\n* Individuals who self-report having pacemakers or other embedded electronic medical devices.\n* Individuals who self-report having an unstable heart condition, severe hypertension or diabetes.\n* Individuals who self-report they are sensitive to nicotine.\n* Individuals who respond with 'Poor' or 'Don't know' to general physical or mental health.\n* Individuals who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.\n* Individuals who are employed by a company that manufactures tobacco, HTPs, marketing or in ongoing litigation with a tobacco company.\n* Individuals who self-report that they are planning to quit all nicotine products in the next three months.\n* Individuals who are personally, have household members, or have close family or friends in ongoing or past litigation with a company that manufactures tobacco or HTPs.\n* People who have taken part in a tobacco\u002Fnicotine research study in the past 30 days.",true,"ALL","21 Years","65 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a parallel design cohort consumer use study to measure the puffing topography of two HTP devices, with two variants of HTP consumables (\"sticks\"), collectively referred to as the study investigational products (Study IP), among a sample of 240 primary users of combustible cigarettes in the United Kingdom (UK). Participants will be using the products for five days at home. Participants demographic characteristics (including age and biological sex), and tobacco- and nicotine-containing products (TNPs) use history will be collected using self-reported questionnaires. Participants will be asked to complete daily surveys using a survey link. Surveys will collect data on the number of CC smoked and number of sticks consumed the previous day in addition to any other tobacco or nicotine product used. In addition, at the end of the study, participants will complete a survey regarding overall product liking and purchase intent.",[28],"Cigarette Smokers","NOT_YET_RECRUITING","2026-06-29",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":22},"2026-06",{"date":37,"type":22},"2026-07",{"name":39,"class":40},"RAI Services Company","INDUSTRY",2,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":5},"100638499","a-study-to-determine-the-effects-of-ends-flavor-availability-on-abstinence-within-smokers-100638499","NCT07598136","A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers","A Randomized Controlled Trial to Determine the Effect of Flavor Availability on Smoking Abstinence With an Electronic Nicotine Delivery System in Primary Combustible Cigarette Smokers","Inclusion Criteria:\n\n* Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.\n* Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent.\n* All female (assigned at birth) and those who identify as \"intersex\" or \"unknown candidate\" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.\n* Currently smoke at least 5 CC on smoking days in the past 30 days.\n* Smoke CC on 15 or more of the past 30 days.\n* Smoked at least 100 factory-made CC in their lifetime prior to the SEV.\n* Indicate a willingness to use ENDS.\n* Own and regularly use a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications.\n* Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.\n\nExclusion Criteria:\n\n* Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.\n* Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.\n* Female participants who self-report not using adequate methods to prevent pregnancy.\n* Persons with pacemakers or other embedded electronic medical devices fitted.\n* Participants who self-report having an unstable heart condition, severe hypertension or diabetes.\n* Persons who self-report they are allergic\u002Fsensitive to cosmetics or fragrances, or any ingredient listed in commercial e-cigarette products.\n* Participants who self-report poor physical or mental health.\n* Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, other combustible products and other oral nicotine products (tablets, gums and lozenges) on 5 or more days in the past 30 days.\n* Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.\n* Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.\n* Employee of a company that manufactures tobacco or ENDS products.\n* Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.\n* Have taken part in a tobacco\u002Fnicotine research study in the past 30 days.",{"count":50,"type":22},1280,[25],"The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco\u002Fnon-menthol\u002Fnon-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.",[54,55],"Smoking","Tobacco",[57,54,58,59],"Tobacco Harm Reduction","Tobacco Use","Tobacco Smoking","RECRUITING","2026-06-01",{"date":63,"type":33},"2026-06-03",{"date":65,"type":33},"2026-05-14",{"date":67,"type":22},"2027-01-21",{"name":39,"class":40},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100639243","abuse-liability-of-two-modern-oral-nicotine-pouched-products-100639243","NCT07595055","Abuse Liability of Two Modern Oral Nicotine Pouched Products","An In-Clinic Confinement Study to Assess Elements of Abuse Liability of Two Modern Oral Nicotine Pouched Products","Inclusion Criteria:\n\n1. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.\n2. Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.\n3. Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco and who also use ST (e.g., moist snuff).\n4. Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of an investigator.\n5. Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the participant.\n6. Reports daily use of ST products (i.e., moist snuff) and agrees to use the same UB ST throughout the study period. The UB moist snuff is defined as the reported moist snuff brand and style currently used most frequently by the participant.\n7. Expired breath carbon monoxide (eCO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day 1).\n8. Positive urine cotinine test (i.e., ≥200 ng\u002FmL) via dipstick at Screening and at Check-in Day 1.\n9. Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 (\"How soon after you wake up do you smoke your first cigarette?\") is either \"Within 5 minutes\" or \"6-30 minutes\" (Heatherton et al., 1991) OR response at Screening to \"How soon after you wake up do you place your first dip?\" is either \"Within 5 minutes\" or \"6-30 minutes\" from the Fagerström Test for Nicotine Dependance-Smokeless Tobacco (FTND-ST) (Ebbert et al., 2006).\n10. Willing to use Study IPs, their UB cigarette and UB moist snuff (Study IP Product S) during the study period.\n11. Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of four Test Sessions.\n12. Females must be willing to use a form of contraception acceptable to an investigator from the time of signing the ICF until End-of-Study.\n\n    Examples of acceptable means of birth control are, but not limited to:\n    1. Surgical sterilization (hysterectomy, bilateral tubal ligation\u002Focclusion, bilateral oophorectomy, bilateral salpingectomy);\n    2. physical barrier method (e.g., condom, diaphragm\u002Fsponge\u002Fcervical cap) with spermicide;\n    3. abstinence;\n    4. non-hormone releasing intrauterine devices (IUD);\n    5. vasectomized partner; or\n    6. post-menopausal and not on hormone replacement therapy.\n13. Agrees to an in-clinic confinement of five days (four nights).\n14. BMI within 18.0 to 40.0 kg\u002Fm2, inclusive (minimum weight of at least 50.0 kg at Screening)\n\nExclusion Criteria:\n\n1. Allergic to or cannot tolerate mint or wintergreen flavoring agents.\n2. Individuals or their family members that have ongoing litigation with tobacco company(ies).\n3. Have used electronic nicotine delivery system or tobacco heating device within the 30 days prior to screening.\n4. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.\n5. History, presence of, or clinical laboratory test results indicating diabetes.\n6. Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at an investigator discretion.\n7. History or presence of bleeding or clotting disorders.\n8. Any history of cancer, except for primary cancers of skin such as localized basal cell\u002Fsquamous cell carcinoma that has been surgically and\u002For cryogenically removed.\n9. Systolic blood pressure of \\> 160 mmHg or a diastolic blood pressure of \\> 95 mmHg, measured after being seated for five minutes at Screening or at check-in Day 1.\n10. Hemoglobin level is \\\u003C 12.5 g\u002FdL for females or \\\u003C 13.0 g\u002FdL for males at Screening.\n11. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.\n12. Has positive urine drug screen (UDS) or alcohol test (urine or breath) at Screening or at Check-in to the Assessment Phase (Day 1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at check-in (Day 1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of an investigator.\n13. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).\n14. Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Wegovy®, Mounjaro®, and Ozempic®), or lobelia extract within 30 days prior to signing the informed consent.\n15. Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent.\n16. Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants.\n17. Individuals ≥ 35 years of age currently using systemic, testosterone, estrogen-containing contraception or hormone replacement therapy.\n18. Whole blood donation or lost blood or blood products in excess of 500 mL within 8 weeks (≤ 56 days) prior to signing the informed consent and between Screening and check-in Day 1.\n19. Plasma donation within (≤) 7 days prior to signing the informed consent and between Screening and check-in Day 1.\n20. Employed by a tobacco or nicotine company, the study site, or handles raw, unpackaged tobacco- or nicotine-containing products as part of their job.\n21. Has used an investigational drug, device, biologic, or tobacco\u002Fnicotine product in a previous clinical study within 30 days or 5 times the half-life of the product (whichever is longer) prior to Screening.\n22. Drinks more than 21 servings of alcoholic beverages per week.\n23. Determined by an investigator to be inappropriate for this study.","60 Years",{"count":78,"type":22},40,[25],"This is a single-site, open-label, randomized, 4-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \\[PD\\]) and plasma nicotine uptake (pharmacokinetics \\[PK\\]) during controlled monitored use and following ad libitum use of the study investigational products (IPs) by generally healthy smokers who are also users of smokeless tobacco.",[54,82,58,59],"Smoking Behaviors","2026-05-12",{"date":85,"type":33},"2026-05-19",{"date":87,"type":22},"2026-06-15",{"date":89,"type":22},"2026-11-30",{"name":39,"class":40},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100617818","a-study-to-assess-nicotine-uptake-from-electronic-nicotine-delivery-systems-100617818","NCT07323563","A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems","A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products","Inclusion Criteria:\n\n* Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.\n* Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.\n* Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening.\n* Positive urine cotinine test at Screening.\n* Smokes combustible, filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.\n* Agrees to smoke same UB cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the participant.\n* Participants must meet one (a or b) of the following tobacco use conditions:\n\n  1. Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (more than 30 days prior to Screening), or clinical study participation (more than 30 days prior to Screening) will be allowed at the discretion of the Principal Investigator (PI).\n  2. Dual user of cigarettes and ENDS who self-reports:\n\n  i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence more than 30 days prior to Screening due to illness, quit attempt, or clinical study participation will be allowed at the discretion of the PI and ii. Using a nicotine-containing ENDS (cartridge or tank system). NOTE: Cigarette smokers or ENDS users who also use other tobacco- or nicotine-containing products (e.g., smokeless tobacco and modern oral nicotine products) on no more than 1 day per week will not be excluded from study participation.\n* Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 (\"How soon after you wake up do you smoke your first cigarette?\") is either \"Within 5 minutes\" or \"6-30 minutes.\"\n* Willing to use only UB cigarette and assigned test ENDS IPs during the study period.\n* Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each test session.\n* Females must be willing to use a form of contraception acceptable to an Investigator, including abstinence from heterosexual intercourse, from the time of signing informed consent until EOS. Examples of acceptable means of birth control include, but are not limited to:\n\n  1. Surgical sterilization (hysterectomy, bilateral tubal ligation\u002Focclusion, bilateral oophorectomy, bilateral salpingectomy);\n  2. Physical barrier method (e.g., condom, diaphragm\u002Fsponge\u002Fcervical cap) with spermicide;\n  3. Non-hormone-releasing intrauterine devices (IUDs) or hormone-releasing IUDs (e.g., Mirena or Kyleena);\n  4. Vasectomized partner;\n  5. Post-menopausal and not on hormone replacement therapy; or\n  6. Sexual abstinence, defined as refraining from intercourse, when this is in line with the preferred and usual lifestyle of the participant.\n* Males must use an acceptable method of birth control from Day 1 Check-in until EOS, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children.\n* Agrees to in-clinic confinement of 10 days and 9 nights.\n\nExclusion Criteria:\n\n* Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.\n* History, presence of, or clinical laboratory test results indicating diabetes.\n* Systolic blood pressure of \\> 160 mmHg or a diastolic blood pressure of \\> 95 mmHg, measured after being seated for 5 minutes at Screening and at Check-in Day 1.\n* Weight of ≤ 110 pounds (≤ 50.0 kg) and body mass index of \\> 40.0 kg\u002Fm2 at Screening.\n* Hemoglobin level is \\\u003C 12.5 for females or \\\u003C 13.0 for males g\u002FdL at Screening.\n* Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion.\n* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).\n* Any history of cancer, except for primary cancers of skin such as localized basal cell\u002Fsquamous cell carcinoma that has been surgically and\u002For cryogenically removed.\n* Must not be a current regular user (i.e., \\> 5 times per month) of any tobacco- or nicotinecontaining products other than cigarettes or ENDS within the last 6 months prior to Screening.\n* Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), glucagon-like peptide-1 (GLP-1) agonists (e.g., Wegovy®, Mounjaro®, Ozempic®), or lobelia extract within ≤ 30 days prior to the signing of informed consent.\n* History or presence of bleeding or clotting disorders.\n* Use of daily aspirin (≥ 325 mg) or other daily anticoagulants.\n* Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and Check-in Day 1.\n\nNOTE: Participants will be advised against scheduling a whole blood donation for at least 7 days following study completion.\n\n• Plasma donation within ≤ 7 days prior to the signing of informed consent and between Screening and Check-in Day 1.\n\nNOTE: Participants will be advised against scheduling a plasma donation for at least 7 days following study completion.\n\n* Participation in another clinical trial within ≤ 30 days prior to the signing of informed consent. The 30-day window for each participant will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.\n* Females who have a positive pregnancy test at Screening or Check-in on Day 1, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.\n* Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.\n* Has positive urine drug screen or alcohol test (urine or breath) at Screening or at Checkin to the Assessment Phase (Day 1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at Check-in (Day 1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of an Investigator.\n* Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within ≤ 30 days prior to the signing of the ICF.\n* Has a significant history of alcoholism or drug abuse within 24 months prior to Screening, as determined by the PI, or has a positive alcohol test at Screening or Checkin on Day 1.\n* Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.\n* Individuals or their family members who have ongoing litigation with tobacco company(ies).\n* Determined by the PI to be inappropriate for this study.",{"count":78,"type":22},[25],"This will be an open-label, randomized, single-site, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters and overall product liking (OPL) following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult combustible cigarette smokers and smokers who also use ENDS products.",[54,82,58,59],"2025-12-22",{"date":104,"type":33},"2026-01-07",{"date":106,"type":22},"2026-03-15",{"date":108,"type":22},"2026-08-31",{"name":39,"class":40},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100617814","abuse-liability-for-eight-electronic-nicotine-products-100617814","NCT07323511","Abuse Liability for Eight Electronic Nicotine Products","An Open-Label, Randomized, 8-way Crossover Study to Assess Elements of Abuse Liability of Electronic Nicotine Delivery System Products in Adult Smokers","Inclusion Criteria:\n\n* Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.\n* Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of consent.\n* Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.\n* Positive (≥200 ng\u002Fml) urine cotinine test at Screening.\n* Smokes only combustible filtered, menthol or non-menthol cigarettes, 83 mm to 100 mm in length.\n* Agrees to smoke same UB cigarette throughout the study period. UB cigarette is defined as the cigarette brand style currently smoked most frequently by the participant.\n* Participants must meet one (a or b) of the following tobacco use conditions:\n\n  1. Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (more than 30 days prior to Screening), or clinical study participation (more than 30 days prior to Screening) will be allowed at the discretion of the Principal Investigator (PI).\n  2. Dual user of cigarettes and ENDS who self-reports:\n\n  i. Smoking at least 10 cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening Visit. Brief periods of abstinence more than 30 days prior to screening due to illness, quit attempt or clinical study participation will be allowed at the discretion of the PI and ii. Using a nicotine-containing ENDS (cartridge or a tank system). NOTE: Cigarette smokers or ENDS users who also use other tobacco- or nicotine-containing products (e.g., smokeless tobacco, and modern oral nicotine products) on no more than one day per week will not be excluded from study participation.\n* Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 (\"How soon after you wake up do you smoke your first cigarette?\") is either \"Within 5 minutes\" or \"6-30 minutes.\"\n* Willing to use only UB cigarette, ENDS IPs, and nicotine gum during the study period.\n* Willing to abstain from tobacco and nicotine use for at least 12 hours prior to each test session.\n* Females must be willing to use a form of contraception acceptable to the PI from the time of signing informed consent until End-of-Study.\n* Males must use an acceptable method of birth control from Day 1 \"check-in\" until the end of the study, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children.\n* Agrees to in-clinic confinement of 10 days and 9 nights.\n\nExclusion Criteria:\n\n* Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.\n* History, presence of, or clinical laboratory test results indicating diabetes.\n* Systolic blood pressure of \\> 160 mmHg or a diastolic blood pressure of \\> 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.\n* Weight of ≤ 110 pounds at Screening.\n* Hemoglobin level is \\\u003C 12.5 g\u002FdL for females or \\\u003C13.0 g\u002FdL for males at Screening.\n* Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion.\n* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).\n* Any history of cancer, except for primary cancers of skin such as localized basal cell\u002Fsquamous cell carcinoma that has been surgically and\u002For cryogenically removed.\n* Must not be a current regular user (i.e., \\> 5 times per month) of any tobacco products other than cigarettes or ENDS within the last 6 months prior to screening.\n* Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Wegovy®, Mounjaro®, and Ozempic®), or lobelia extract within ≤ 30 days prior to the signing of informed consent.\n* History or presence of bleeding or clotting disorders.\n* Use of daily aspirin (≥ 325 mg) or other daily anticoagulants.\n* Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.\n\nNOTE: Participants will be advised against scheduling a whole blood donation for at least 7 days following study completion.\n\n• Plasma donation within ≤ 7 days prior to the signing of informed consent and between Screening and check-in Day 1.\n\nNOTE: Participants will be advised against scheduling a plasma donation for at least 7 days following study completion.\n\n* Participation in another clinical trial within ≤ 30 days prior to the signing of informed consent. The 30-day window for each participant will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.\n* Females who have a positive pregnancy test at Screening or check-in on Day 1, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.\n* Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.\n* A positive drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.\n* Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within ≤ 30 days prior to the signing of the ICF.\n* Has a significant history of alcoholism or drug abuse within 24 months prior to Screening, as determined by the PI, or has a positive alcohol test at Screening or check-in on Day 1.\n* Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.\n* Individuals or their family members that have ongoing litigation with tobacco company(ies).\n* Determined by the PI to be inappropriate for this study.",{"count":118,"type":22},70,[25],"This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \\[PD\\]), and plasma nicotine uptake (pharmacokinetics \\[PK\\]) during and following ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.",[54,82,58,59],{"date":104,"type":33},{"date":124,"type":22},"2026-02-15",{"date":126,"type":22},"2026-09-15",{"name":39,"class":40},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":144,"locationsCount":145},"100603153","abuse-liability-for-five-modern-oral-nicotine-products-100603153","NCT07132814","Abuse Liability for Five Modern Oral Nicotine Products","An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Five Modern Oral Nicotine Products","Inclusion Criteria:\n\n1. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.\n2. Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.\n3. Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.\n4. Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of an investigator.\n5. Smokers who also use ST products (e.g., moist snuff, snus, modern oral), and have used ST within 30 days prior to screening, will be enrolled.\n6. Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the participant.\n7. Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening.\n8. Positive urine cotinine test (e.g., \\>200 ng\u002FmL) via dipstick at Screening.\n9. Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 (\"How soon after you wake up do you smoke your first cigarette?\") is either \"Within 5 minutes\" or \"6-30 minutes\" .\n10. Willing to use the UB cigarette, Study IPs, and Nicorette® nicotine gum (Arm 2 only) during the study period.\n11. Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of four Test Sessions.\n12. Females must be willing to use a form of contraception acceptable to an investigator from the time of signing the ICF until End-of-Study.\n\n    Examples of acceptable means of birth control are, but not limited to:\n    1. Surgical sterilization (hysterectomy, bilateral tubal ligation\u002Focclusion, bilateral oophorectomy, bilateral salpingectomy);\n    2. physical barrier method (e.g., condom, diaphragm\u002Fsponge\u002Fcervical cap) with spermicide;\n    3. non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g., Mirena or Kyleena);\n    4. vasectomized partner; or\n    5. post-menopausal and not on hormone replacement therapy.\n13. Agrees to an in-clinic confinement of five days (four nights).\n\nExclusion Criteria:\n\n1. Allergic to or cannot tolerate mint or wintergreen flavoring agents.\n2. Individuals or their family members that have ongoing litigation with tobacco company(ies).\n3. Have used electronic nicotine delivery system (e.g., Vuse Alto, JUUL) or tobacco heating device (e.g., iQOS) within the last 30 days prior to screening.\n4. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.\n5. History, presence of, or clinical laboratory test results indicating diabetes.\n6. Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at an investigator discretion.\n7. History or presence of bleeding or clotting disorders.\n8. Any history of cancer, except for primary cancers of skin such as localized basal cell\u002Fsquamous cell carcinoma that has been surgically and\u002For cryogenically removed.\n9. Systolic blood pressure of \\> 160 mmHg or a diastolic blood pressure of \\> 95 mmHg, measured after being seated for five minutes at Screening or at check-in Day -1.\n10. Weight of ≤ 50.0 kg at screening or at check-in.\n11. Hemoglobin level is \\\u003C 12.5 g\u002FdL for females or \\\u003C 13.0 g\u002FdL for males at Screening.\n12. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.\n13. Has positive urine drug screen (UDS) or alcohol test (urine or breath) at Screening or at Check-in to the Assessment Phase (Day -1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at check-in (Day -1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of an investigator.\n14. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).\n15. Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to signing the informed consent.\n16. Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent.\n17. Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants.\n18. Individuals ≥ 35 years of age currently using systemic, testosterone, estrogen-containing contraception or hormone replacement therapy.\n19. Whole blood donation or lost blood or blood products in excess of 500 mL within 8 weeks (≤ 56 days) prior to signing the informed consent and between Screening and check-in Day -1.\n20. Plasma donation within (≤) 7 days prior to signing the informed consent and between Screening and check-in Day -1.\n21. Employed by a tobacco or nicotine company, the study site, or handles raw, unpackaged tobacco- or nicotine-containing products as part of their job.\n22. Has used an investigational drug, device, biologic, or tobacco\u002Fnicotine product in a previous clinical study within 30 days or 5 times the half-life of the product (whichever is longer) prior to Screening.\n23. Drinks more than 21 servings of alcoholic beverages per week.\n24. Determined by an investigator to be inappropriate for this study.",{"count":78,"type":22},[25],"This is a two-site, open-label, randomized, 4-way (2 arm) cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \\[PD\\]) and plasma nicotine uptake (pharmacokinetics \\[PK\\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers",[54,82,58,59],{"date":140,"type":33},"2025-12-30",{"date":142,"type":33},"2025-12-15",{"date":108,"type":22},{"name":39,"class":40},1,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":76,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":4},"100613484","abuse-liability-for-four-heated-tobacco-product-htp-consumables-and-two-htp-devices-100613484","NCT07267195","Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices","An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices","Inclusion Criteria:\n\n* Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.\n* Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.\n* Smokes combustible, filtered, non-menthol (Arm 1 only) or menthol cigarettes (Arm 2 only), 83 mm to 100 mm in length as primary source of tobacco. Smokers who also use other tobacco products (e.g., ENDS, smokeless tobacco, HTPs) will not be excluded from study participation,\n* Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the PI.\n* Agrees to smoke the same UB cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the participant.\n* Expired breath carbon monoxide (ECO) level is ≥ 10 ppm and ≤ 100 ppm at Screening and at check-in (Day -1).\n* Positive urine cotinine test (e.g., \\>200 ng\u002FmL) via dipstick at Screening.\n* Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 (\"How soon after you wake up do you smoke your first cigarette?\") is either \"Within 5 minutes\" or \"6-30 minutes\" (Heatherton et al., 1991).\n* Willing to use the UB cigarette, Study IPs, and Nicorette® nicotine gum during the study period.\n* Willing to abstain from tobacco and nicotine use for at least 12 hours prior to the start of each of four Test Sessions.\n* Females must be willing to use a form of contraception acceptable to the PI from the time of signing the ICF until End-of-Study.\n* Examples of acceptable means of birth control are, but not limited to:\n\n  * Surgical sterilization (hysterectomy, bilateral tubal ligation\u002Focclusion, bilateral\n  * oophorectomy, bilateral salpingectomy);\n  * physical barrier method (e.g., condom, diaphragm\u002Fsponge\u002Fcervical cap) with\n  * spermicide;\n  * non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs\n  * (e.g., Mirena or Kyleena);\n  * vasectomized partner; or\n  * post-menopausal and not on hormone replacement therapy\n  * abstinence.\n* Males must use an acceptable method of birth control from Day -1 \"check-in\" until the End-of-Study, unless they have had a vasectomy or are abstinent from heterosexual intercourse, or their female partner is not able to bear children.\n* Agrees to an in-clinic confinement of 10 days (9 nights).\n* BMI within 18.0 to 40.0 kg\u002Fm2, inclusive (minimum weight of at least 50.0 kg at Screening).\n\nExclusion Criteria:\n\n* Individuals or their family members that have ongoing litigation with tobacco company(ies).\n* Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study participant unsuitable to participate in this clinical study.\n* History, presence of, or clinical laboratory test results indicating diabetes.\n* Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion.\n* History or presence of bleeding or clotting disorders.\n* Any history of cancer, except for primary cancers of skin such as localized basal cell\u002Fsquamous cell carcinoma that has been surgically and\u002For cryogenically removed.\n* Systolic BP of \\> 160 mmHg or a diastolic BP of \\> 95 mmHg, measured after being seated for 5 minutes at Screening or at check-in Day -1.\n* Weight of \\> 50.0 kg at Screening.\n* Hemoglobin level is \\> 12.5 g\u002FdL for females or \\> 13.0 g\u002FdL for males at Screening.\n* Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.\n* Has positive urine drug screen or alcohol test (urine or breath) at Screening or at Check-in to the Assessment Phase (Day -1), with the exception of positive results for tetrahydrocannabinol (THC). If positive for THC at check-in (Day -1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of the PI.\n* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).\n* Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), GLP-1 agonists (e.g., Mounjaro®, Ozempic®, Wegovy®), or lobelia extract within (≤) 30 days prior to signing the informed consent.\n* Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous quit attempt within (≤) 30 days prior to signing the informed consent.\n* Any use of daily aspirin (≥ 325 mg) or any use of other anticoagulants.\n* Individuals ≥ 35 years of age currently using systemic, testosterone, estrogen-containing contraception or hormone replacement therapy.\n* Whole blood donation or lost blood or blood products in excess of 500 mL within 8 weeks (≤ 56 days) prior to signing the informed consent and between Screening and check-in Day -1.\n* Plasma donation within (≤) 7 days prior to signing the informed consent and between Screening and check-in Day -1.\n* Employed by a tobacco or nicotine company, the study site, or handles raw, unpackaged tobacco- or nicotine-containing products as part of their job.\n* Has used an investigational drug, device, biologic, or tobacco\u002Fnicotine product in a previous clinical study within 30 days or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Drinks more than 21 servings of alcoholic beverages per week.\n* Determined by the PI to be inappropriate for this study.",{"count":78,"type":22},[25],"This is a single-site, open-label, randomized, 8-way crossover study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \\[PD\\]) and plasma nicotine uptake (pharmacokinetics \\[PK\\]), during and following ad libitum use of the study investigational products (IPs) by generally healthy adult smokers.",[54,82,58,59],"2025-12-08",{"date":159,"type":33},"2025-12-16",{"date":161,"type":22},"2026-01",{"date":163,"type":22},"2026-12",{"name":39,"class":40},""]