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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Smoking Cessation, Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT06617312

Run by

University of California, Los Angeles

People needed

64

Starts

2024-12-05

Expected to finish

2026-12-01

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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 more than 5 times in the 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 mild-to-moderate 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

Where it is running

• University of California Los Angeles — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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