Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

Eligibility Criteria

• 1. be between the ages of 18 and 65 and provide informed consent;
• 2. smoke 5 or more combustible cigarettes per day;
• 3. not seeking treatment for smoking;
• 1. current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT);
• 2. more than 3 months of smoking abstinence in past year;
• 3. use of non-cigarette tobacco product (pipe tobacco, cigars, smokeless tobacco, hookah) or electronic cigarettes in 28-days prior to enrollment;
• 4. current use of psychoactive drug (excluding cannabis), as determined by urine toxicology;
• 5. current (past 12-month) DSM-5 diagnosis of substance use disorder for any substances other than tobacco and mild cannabis or alcohol use disorders;
• 6. lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;
• 7. current suicidal ideation or lifetime history of suicide attempt;
• 8. serious medical illness within past 3 months, including recent history of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, or hospitalization for congestive heart failure;
• 9. medical condition that may interfere with safe study participation;
• 10. renal impairment defined as a creatinine clearance (CrCl) greater than 60 mL/min (estimated with the Cockroft-Gault equation);
• 11. exceed Grade 2 laboratory abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials";
• 12. uncontrolled hypertension (blood pressure ≥160/100 mmHg);
• 13. abnormal electrocardiogram;
• 14. non-removable ferromagnetic object in body;
• 15. claustrophobia;
• 16. serious head injury or period of unconsciousness (more than 30 minutes);
• 17. more than 250lbs;
• 18. Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must 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;
• 19. have experienced adverse effects to varenicline;
• 20. have an intense fear of needles or have had an adverse reaction to needle puncture.