THCV Treatment for Smokers

Open to people ages 21-65

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.

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 <90 ml/min;
10. Have evidence of hepatic impairment, defined by a score of ≥5 points on the Child-Pugh assessment of liver function;
11. 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";
12. Have past month use of cannabis or cannabis products;
13. 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;
15. Have any other circumstances that, in the opinion of the investigators, would not be a good fit for study participation.