THCV: a new weapon against smoking?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \<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.