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NCT07636356
THCV Treatment for Smokers
Conditions: Tobacco Use Disorder, Smoking Cessation
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 32
Sponsor: University of California, Los Angeles
Summary
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).
Eligibility Criteria
Inclusion Criteria:
1. Be between the ages of 21 and 65;
2. Smoke 10 or more combustible cigarettes per day;
3. Have fewer than 3 months of smoking abstinence in the past year;
4. Has self-reported ≥10 lifetime uses of cannabis products;
5. Have self-reported recent (past 3-month) use of cannabis products;
6. Agree to abstain from all other cannabinoid use during the study;
7. 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;
8. 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.
Exclusion Criteria:
1. Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;
2. Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;
3. Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;
4. Have a positive urine screen for any substances, including cannabis
5. Have a breathalyzer reading above 0.000 g/dl;
6. Be pregnant, nursing, or planning to become pregnant while taking part in the study;
7. Have a medical condition that may interfere with safe study participation;
8. Have clinically significant abnormalities on the EKG;
9. Have evidence of renal impairment, defined by an eGFR value of \
Source: ClinicalTrials.gov (NCT07636356). StuddyBuddy aggregates publicly available trial information.