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

About

Brief Summary

This study will randomize 64 non-treatment seeking individuals who smoke cigarettes daily in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

65 Years

Inclusion Criteria:

be between the ages of 18 and 65 and provide informed consent;
smoke 5 or more combustible cigarettes per day;
not seeking treatment for smoking;

Exclusion Criteria:

current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT);
more than 3 months of smoking abstinence in past year;
use of non-cigarette tobacco product (pipe tobacco, cigars, smokeless tobacco, hookah) or electronic cigarettes in 28-days prior to enrollment;
current use of psychoactive drug (excluding cannabis), as determined by urine toxicology;
current (past 12-month) DSM-5 diagnosis of substance use disorder for any substances other than tobacco and mild cannabis or alcohol use disorders;
lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;
current suicidal ideation or lifetime history of suicide attempt;
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;
medical condition that may interfere with safe study participation;
renal impairment defined as a creatinine clearance (CrCl) greater than 60 mL/min (estimated with the Cockroft-Gault equation);
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";
uncontrolled hypertension (blood pressure ≥160/100 mmHg);
abnormal electrocardiogram;
non-removable ferromagnetic object in body;
claustrophobia;
serious head injury or period of unconsciousness (more than 30 minutes);
more than 250lbs;
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;
have experienced adverse effects to varenicline;
have an intense fear of needles or have had an adverse reaction to needle puncture.