[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642885":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":36,"locations":25,"responsibleParty":42,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":25},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Δ9-THCV first, then placebo.","EXPERIMENTAL","Participants will first take a 10mg Δ9-THCV gummy once a day for 5 days. After a 14-day washout period, participants will take a matched placebo gummy (0mg Δ9-THCV) once a day for 5 days.",[13,14],"Drug: Δ9-Tetrahydrocannabivarin (oral gummy)","Drug: Matched Placebo (oral gummy)",{"label":16,"type":10,"description":17,"interventionNames":18},"Placebo first, then THCV","Participants will take a placebo gummy (0mg Δ9-THCV) once a day for 5 days. After a 14-day washout period, participants will take a 10mg Δ9-THCV gummy once a day for 5 days.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Δ9-Tetrahydrocannabivarin (oral gummy)","10mg Δ9-Tetrahydrocannabivarin oral gummy",[16,9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Matched Placebo (oral gummy)","Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)",[16,9],[31,34],{"name":32,"affiliation":5,"role":33},"Lara A Ray, PhD","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":5,"role":33},"Erica N Grodin, PhD",[37],{"name":38,"role":39,"phone":40,"phoneExt":25,"email":41},"Jessica Jenkins, MS","CONTACT","310-206-6756","jenkinsj@ucla.edu",{"type":33,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lara Ray, PhD","Professor",[46],{"name":47,"class":48},"National Institute on Drug Abuse (NIDA)","NIH","100642885","phase-2-thcv-treatment-for-smokers-100642885",false,"NCT07636356","THCV Treatment for Smokers","Development of Tetrahydrocannabivarin as a Treatment for Smokers","Inclusion Criteria:\n\n1. Be between the ages of 21 and 65;\n2. Smoke 10 or more combustible cigarettes per day;\n3. Have fewer than 3 months of smoking abstinence in the past year;\n4. Has self-reported ≥10 lifetime uses of cannabis products;\n5. Have self-reported recent (past 3-month) use of cannabis products;\n6. Agree to abstain from all other cannabinoid use during the study;\n7. Agree to abstain from all other medication use during the study, other than methods of birth control as listed in inclusion criteria for female participants;\n8. Agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile: oral contraceptives, Contraceptive sponge, patch, double barrier, intrauterine contraceptive device, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, hormonal vaginal contraceptive ring, complete abstinence from sexual intercourse.\n\nExclusion Criteria:\n\n1. Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;\n2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;\n3. Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;\n4. Have a positive urine screen for any substances, including cannabis\n5. Have a breathalyzer reading above 0.000 g\u002Fdl;\n6. Be pregnant, nursing, or planning to become pregnant while taking part in the study;\n7. Have a medical condition that may interfere with safe study participation;\n8. Have clinically significant abnormalities on the EKG;\n9. Have evidence of renal impairment, defined by an eGFR value of \\\u003C90 ml\u002Fmin;\n10. Have evidence of hepatic impairment, defined by a score of ≥5 points on the Child-Pugh assessment of liver function;\n11. Exceed Grade 2 laboratory or vital sign abnormalities, based on FDA Guidance Document \"Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials\";\n12. Have past month use of cannabis or cannabis products;\n13. Have past month use of electronic nicotine delivery system (ENDS);\n14. Have use of any medications (other than methods of birth control as listed in inclusion criteria for female participants) within 14 days or 5 half-lives (whichever is longer) prior to study drug administration, and throughout the study, including medication for smoking cessation, any prescription, OTC, dietary supplements, herbal products, or vitamins;\n15. Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.","ALL","21 Years","65 Years",{"count":60,"type":61},32,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","This study will randomize 32 non-treatment-seeking individuals who smoke cigarettes daily into a randomized, crossover, double-blind, placebo-controlled study testing the safety, tolerability, and initial efficacy of Δ9-tetrahydrocannabivarin (Δ9-THCV).",[67,68],"Tobacco Use Disorder","Smoking Cessation",[70,71,72,73,74],"smoking cessation","tobacco use disorder","cigarette smoking","THCV","Tetrahydrocannabivarin","NOT_YET_RECRUITING","2026-06-02",{"date":78,"type":79},"2026-06-09","ACTUAL",{"date":81,"type":61},"2026-07",{"date":83,"type":61},"2028-05-31",{"name":5,"class":6}]