THCV Treatment for Smokers

About

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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

21 Years

Maximum Age

65 Years

Inclusion Criteria:

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;

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;

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:

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);

14. 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;

Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.

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Study Stats

Protocol No.

26-1097