[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Christopher D. Verrico\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100551021","phase-2-dronabinol-as-an-adjunct-for-reducing-pain-100551021",false,"NCT06454669","Dronabinol as an Adjunct for Reducing Pain","A Randomized, Double-Blind, Placebo-Controlled, Parallel Groups Study to Explore the Safety and Therapeutic Potential of Dronabinol as an Adjunct for Reducing Pain","DARP","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Ability to take oral medication per protocol.\n4. Male or female, aged 18-64 years.\n5. Has chronic low back pain (i.e., in the space between the lower posterior margin of the rib cage and the horizontal gluteal fold) that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months (Items 1 \\& 2 from the Research Standards for Chronic Low-Back Pain (RScLBP) assessment).\n6. For females of reproductive potential: currently practicing an effective form of two types of birth control, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, for at least 1 month prior to screening and agrees to use such a method during study participation and for an additional 4 weeks after the end of study medication administration unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year):\n\n   1. oral contraceptives,\n   2. contraceptive sponge,\n   3. patch,\n   4. double barrier (diaphragm\u002Fspermicidal or condom\u002Fspermicidal),\n   5. intrauterine contraceptive system,\n   6. etonogestrel implant,\n   7. medroxyprogesterone acetate contraceptive injection,\n   8. complete abstinence from sexual intercourse, and\u002For hormonal vaginal contraceptive ring.\n7. Agree (if male) to use acceptable methods of contraception if the male participant's partner could become pregnant from the time of the first administration of the study drug until 30 days following the final administration of the study drug. One of the following acceptable methods of contraception must be utilized:\n\n   1. Surgical sterilization (vasectomy)\n   2. The participant's female partner uses oral contraceptives (combination estrogen\u002Fprogesterone pills), injectable progesterone or sub dermal implants (commenced at least 14 days prior to study drug administration to the male participant)\n   3. The participant's female partner uses a medically prescribed topically applied transdermal contraceptive patch (commenced at least 14 days prior to study drug administration to the male participant)\n   4. The participant's female partner has undergone tubal ligation (female sterilization) or is postmenopausal (one year)\n   5. The participant's female partner has undergone placement of an intrauterine device or intrauterine system.\n   6. True abstinence: when this is in line with the preferred and usual lifestyle of the participant.\n8. Agreement to adhere to Lifestyle Considerations throughout study duration.\n9. On a stable opioid treatment regimen, with or without other pharmacologic or nonpharmacologic pain treatments, for ≥3 months at the time of the screening and agree to refrain from adding new analgesic medications or increasing their current dose of analgesic medications for the duration of the study.\n\nExclusion Criteria:\n\n1. Non-English speaking or inability to read and understand English.\n2. Current and unwilling to stop the use of cannabis\u002Fmarijuana and any other cannabinoids, including over the counter CBD products.\n3. Reported allergic reactions to cannabis, CBD, THC, or components of the study interventions.\n4. Have Blood Urea Nitrogen or Creatinine levels outside the normal range, or other clinically significant laboratory abnormalities.\n5. Current use of Antiepileptic drugs.\n6. Current use of barbiturates, benzodiazepines, ethanol, lithium, buspirone, muscle relaxants\n7. Current use of amphetamines, other sympathomimetic agents, atropine, amoxapine, scopolamine, antihistamines, other anticholinergic agents, amitriptyline, desipramine, or other tricyclic antidepressants within 3 months of randomization.\n8. Treatment with another investigational drug or other intervention within 3 months of the screening visit.\n9. Pregnancy, plans to become pregnant, or lactation.\n10. Any interventional pain procedures within 6 weeks prior to screening or at any point during study enrollment.\n11. Surgical intervention or introduction\u002Fincreased dose of an opioid or analgesic regimen at any point during study enrollment.\n12. Implanted spinal cord or dorsal root ganglion stimulator for pain treatment.\n13. Meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for a current major psychiatric illness, such as bipolar disorder, major depression, or psychosis.\n14. Have a history of substance abuse or dependence.\n15. Have a history or current suicidality. Have an increased risk of suicide that necessitates inpatient treatment or warrants therapy excluded by the protocol, and\u002For current suicidal plan, per investigator clinical judgement, based on interview and defined on the Columbia Suicidality Severity Rating Scale (C-SSRS).\n16. Have a history of seizures.\n17. Have uncontrolled renal, hepatic, or other systemic disorders that in the opinion of the investigator may jeopardize the patient.\n18. Have a history of cardiac disorders.\n19. Myocardial infarction or stroke in the previous 6 months.\n20. Resting heart rate of \\> 120.\n21. Systolic blood pressure \\> 140 mm Hg, or diastolic blood pressure \\> 90 mm Hg.\n22. Any uncontrolled communicable disease (e.g., human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), tuberculosis, coronavirus disease (COVID), etc.).\n23. Have any other illness, condition, or use of medications, which in the opinion of the P.I. and\u002For the admitting clinician would preclude the safe and\u002For successful completion of the study.\n24. Have a history of head trauma, epilepsy, or a cognitive disorder (Alzheimer's Disease, dementia).\n25. Have an electrocardiogram (ECG) abnormalities at screening including but not limited to bradycardia (\\\u003C55 beats per minute); prolonged heart-rate corrected QT interval (QTc) interval (\\>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).",true,"ALL","18 Years","64 Years",{"count":22,"type":23},75,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","This exploratory, proof-of-concept study is a double-blind (participants and investigators will be blinded), placebo-controlled, randomized, two-arm clinical trial of Marinol \\[dronabinol, synthetic Δ9-tetrahydrocannabinol (THC)\\] for chronic low back pain (cLBP) with a 2:1 allocation ratio. Up to 75 subjects will be enrolled in this pilot study and randomized to receive doses of THC (up to 30 mg\u002Fday), orally, over 8 weeks. This study will be conducted at a single site; it does not include any stratifications, and there is no interim analysis planned. Notably, the goal is to determine whether there is enough evidence of the safety of THC to support the development of later-phase clinical trials. Thus, detailed developmental plans are contingent on the outcomes of this study.",[29,30,31],"Low Back Pain","Chronic Pain","Back Injuries",[33,34,35],"dronabinol","Marinol","THC","RECRUITING","2026-05-15",{"date":39,"type":40},"2026-05-18","ACTUAL",{"date":42,"type":40},"2024-06-15",{"date":44,"type":23},"2029-12-31",{"name":46,"class":47},"Christopher D. Verrico","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":48},"100609743","phase-1-evaluation-of-the-safety-and-effects-of-psychoactive-substances-in-people-with-past-opioid-use-100609743","NCT07218549","Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use","Inclusion Criteria:\n\n1. English-speaking, 18- to 55-year-old males or females.\n2. Female subjects must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission. In addition, female subjects must meet one of the following conditions:\n\n   * Is a woman of non-childbearing potential defined as no menses for at least 12 months with status confirmed by FSH and estradiol levels at screening or surgically sterile at screening visit OR\n   * Is a woman of childbearing potential and using a contraceptive method that is highly effective, with a failure rate of \\\u003C1%, from Screening until 9 months after receiving the study medication. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the dose of study intervention.\n3. Male subjects must agree to the following from Day 1 until 9 months after receiving the study medication:\n\n   • Not donate fresh unwashed semen\n\n   Plus, either:\n   * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n   * Use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.\n   * Use a male condom when engaging in any activity that allows for passage of ejaculate to another person\n4. Physically healthy, as determined by a clinical interview with a physician, laboratory tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, and self-reported medical history.\n5. No current or past diagnosis of severe mental illness, as determined by a clinical interview.\n6. Clinical laboratory test results (CMP, CBC, etc.) must be within the normal reference range or with acceptable deviations that are judged to be not clinically significant by a study physician.\n7. Have a history of self-reported recreational opioid use as defined by at least 10 times in the past year and at least once in the 12 weeks before screening.\n8. Able and willing to give signed informed consent, reliable, and willing to make themselves available for the study's duration and follow study procedures.\n9. Agree not to consume any recreational drugs during the study (THC is excluded).\n10. Able to perform study procedures as determined by clinical judgment.\n11. Able to meet eligibility requirements of the Qualification Phase (i.e., drug discrimination) and Naloxone Challenges.\n\nExclusion Criteria:\n\n1. Seeking treatment for a substance or alcohol use disorder as determined by self-report during the intake interview.\n2. Current or past diagnosis of opioid use disorder or other substance use disorder (SUD) within the past year, excluding THC and nicotine-containing products. With regard to marijuana\u002FTHC, an individual must be able to tolerate 48 hours of abstinence from marijuana\u002FTHC products.\n3. History of opioid overdose.\n4. Using medication or supplements that might interact with kratom or oxycodone as determined by self-report during intake interview.\n5. Treatment with any investigational drug during the last 30 days.\n6. Participants on parole or probation.\n7. Currently pregnant or trying to conceive or currently lactating as determined by blood pregnancy testing at screening, urine pregnancy testing at admission, and self-reporting during interview and study visits.\n8. Current or recent history of significant violent or suicidal behavior or suicidal\u002Fhomicidal risk as determined by the C-SSRS.\n9. Sensitivity, allergy, or contraindications\u002Fallergies to kratom, opioids, or similar compounds.\n10. Use prescription or nonprescription drugs and dietary supplements within seven days or five half-lives (whichever is longer) that, in the opinion of the study clinician may interfere with the investigational product.\n11. Positive urine drug screen (UDS) for substances of abuse at each admission in the Qualification and Treatment phases, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at their discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.\n12. Positive alcohol breathalyzer test at each admission in the Qualification and Treatment Phase.\n13. History of sensitivity to heparin or heparin-induced thrombocytopenia.\n14. Has not donated blood or plasma within the last six weeks.\n15. Has a history of increased intracranial pressure or brain tumors.\n16. Has gastrointestinal obstruction, including paralytic ileus.\n17. Has a history of seizure disorders.\n18. Has a chronic obstructive pulmonary disease or cor pulmonale.\n19. Has a history of anemia or any other significant hematologic disorder.\n20. Has a condition or abnormality that, in the opinion of the PI or Study Physician, would compromise the safety of the patient or the quality of the data.\n21. Has a major surgery planned within the next 6 months.","55 Years",{"count":57,"type":23},72,[59],"PHASE1","The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.",[62,63,64],"Opioid Use","Substance Use Disorders","Opioid Analgesia",[62,63],"NOT_YET_RECRUITING","2026-03-11",{"date":69,"type":40},"2026-03-13",{"date":71,"type":23},"2026-05-01",{"date":73,"type":23},"2029-05-31",{"name":46,"class":47},""]