Health TrialsbyHealthPanel

THCV Treatment for Smokers

ConditionsTobacco Use DisorderSmoking Cessation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of California, Los Angeles

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Δ9-Tetrahydrocannabivarin (oral gummy)

    Drug

    10mg Δ9-Tetrahydrocannabivarin oral gummy

  • Matched Placebo (oral gummy)

    Drug

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Δ9-THCV first, then placebo.Experimental treatment 2 interventions
Group B: Placebo first, then THCVExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Assessed during each 5-day medication condition, following overnight abstinence on Day 5
2

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).

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

Secondary outcomes

1

Questionnaire of Smoking Urges-Brief total score

Participants will complete the 10-item Questionnaire of Smoking Urges-Brief (QSU-Brief) during the McKee Smoking Lapse Task to assess cigarette craving. The QSU-Brief assesses urges and cravings using a 7-point Likert response scale, with higher scores indicating greater craving (range: 10-70). Cue-induced cigarette craving in response to cigarette (vs. neutral) cues will be calculated and compared between the Δ9-THCV and placebo conditions.

Time frame
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
2

Minnesota Nicotine Withdrawal Scale score

Participants will complete ratings of nicotine withdrawal following overnight abstinence using the 8-item Minnesota Nicotine Withdrawal Scale (MNWS), with higher values indicating more severe withdrawal (range: 0-32). Differences in MNWS scores will be evaluated between the Δ9-THCV and placebo conditions.

Time frame
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence
3

Modified Cigarette Evaluation Questionnaire satisfaction score

Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess satisfaction associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The satisfaction subscale score is calculated as the sum of Items 1, 2, and 12 (range: 3-21). Differences in satisfaction scores will be evaluated between the Δ9-THCV and placebo conditions.

Time frame
Assessed during each 5-day medication condition during the Day 5 laboratory session following overnight abstinence.
4

Modified Cigarette Evaluation Questionnaire psychological reward score

Participants will complete the 12-item Modified Cigarette Evaluation Questionnaire (mCEQ) during the cigarette self-administration period of the McKee Smoking Lapse Task to assess psychological reward associated with smoking. Items are rated on a 7-point scale, with higher scores indicating greater endorsement. The psychological reward subscale score is calculated as the sum of Items 4, 5, 6, 7, 8 (range: 5-35). Differences in psychological reward scores will be evaluated between the Δ9-THCV and placebo conditions.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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