THCV Treatment for Smokers

NCT07636356 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-26-1097R21DA059769
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Tobacco Use Disorder; Smoking Cessation

Keywords

smoking cessation; tobacco use disorder; cigarette smoking; THCV; Tetrahydrocannabivarin

Outcome Measures

Primary Outcomes (2)

• Latency to initiate smoking

  Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on the ability to resist smoking. The primary outcome is latency to initiate smoking during the 50-minute delay period, defined as the number of minutes participants delay smoking their first cigarette (range: 0-50 minutes).

  Assessed during each 5-day medication condition, following overnight abstinence on Day 5

• Number of cigarettes smoked during self-administration

  Participants will complete the McKee Smoking Lapse Task following overnight abstinence to assess the effects of oral Δ9-THCV (10 mg), compared with placebo, on cigarette self-administration. The outcome is the number of cigarettes smoked during the 60-minute self-administration period of the task (no set range).

  Assessed during each 5-day medication condition, following overnight abstinence on Day 5

Secondary Outcomes (7)

• Questionnaire of Smoking Urges-Brief total score

  Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence

• Minnesota Nicotine Withdrawal Scale score

  Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence

• Modified Cigarette Evaluation Questionnaire satisfaction score

  Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.

• Modified Cigarette Evaluation Questionnaire psychological reward score

  Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.

• Modified Cigarette Evaluation Questionnaire nausea/dizziness score

  Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.

Study Arms (2)

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.

Drug: Δ9-Tetrahydrocannabivarin (oral gummy); Drug: Matched Placebo (oral gummy)

Placebo first, then THCV

EXPERIMENTAL

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.

Drug: Δ9-Tetrahydrocannabivarin (oral gummy); Drug: Matched Placebo (oral gummy)

Interventions

Matched Placebo (oral gummy) DRUG

Matched Placebo (oral gummy, 0mg Δ9-Tetrahydrocannabivarin)

Placebo first, then THCV; Δ9-THCV first, then placebo.

Δ9-Tetrahydrocannabivarin (oral gummy) DRUG

10mg Δ9-Tetrahydrocannabivarin oral gummy

Placebo first, then THCV; Δ9-THCV first, then placebo.

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between the ages of 21 and 65;
• Smoke 10 or more combustible cigarettes per day;
• Have fewer than 3 months of smoking abstinence in the past year;
• Has self-reported ≥10 lifetime uses of cannabis products;
• Have self-reported recent (past 3-month) use of cannabis products;
• Agree to abstain from all other cannabinoid use during the study;
• 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.

You may not qualify if:

• Have current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine;
• Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any other psychotic disorder;
• Have a score of 3 or greater on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening or anytime during study participation;
• Have a positive urine screen for any substances, including cannabis
• Have a breathalyzer reading above 0.000 g/dl;
• Be pregnant, nursing, or planning to become pregnant while taking part in the study;
• Have a medical condition that may interfere with safe study participation;
• Have clinically significant abnormalities on the EKG;
• Have evidence of renal impairment, defined by an eGFR value of \<90 ml/min;
• Have evidence of hepatic impairment, defined by a score of ≥5 points on the Child-Pugh assessment of liver function;
• 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";
• Have past month use of cannabis or cannabis products;
• Have past month use of electronic nicotine delivery system (ENDS);
• Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation; Cigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Study Officials

• Lara A Ray, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Erica N Grodin, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Jenkins, MS

CONTACT

310-206-6756; jenkinsj@ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study uses a randomized, double-blind, placebo-controlled crossover design in which participants receive both Δ9-THCV (10mg) and a matched placebo across two separate 5-day outpatient medication conditions. Treatment order will be counter-balanced across participants, and the medication conditions will be separated by a 14-day washout period.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share