Effects of Cytisinicline on Smoking Cues in Daily Smokers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how cytisinicline affects the brain's response to cigarette-related cues in daily smokers. A total of 64 participants will be randomly assigned to receive either cytisinicline or a placebo over a 2- to 3-week period. Participants will track their cigarette use and cravings daily, followed by an fMRI session to assess brain activity in response to smoking cues. The study aims to provide insights into the neural mechanisms underlying smoking behavior and cue-reactivity.

Why it matters

Who can join: the full rules

Inclusion 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;

Exclusion Criteria:

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

Where it's running

• University of California Los Angeles
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Dylan E Kirsch, PhD
• Email: dylankirsch@psych.ucla.edu
• Phone: (310) 206-6756

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Multilevel program to increase LDCT lung cancer screening and help African American smokers quit

  This program will try combining low-dose CT screening with culturally tailored smoking-cessation support to help African American smokers who are eligible for LDCT quit and get screened.

  Recruiting at 2 sites Louisiana State University Health Sciences Center in New Orleans · New Orleans, Louisiana and 1 other locations · NCT07576595

• Education program for quitting smoking

  This study is testing an education program to help people with mental health disorders who smoke to quit by providing support from nurses.

  Recruiting Erzurum Technical University · Erzurum, Erzurum · NCT06930547

• Quitting Matters: a smoking quit program for people living with HIV

  This 6-month program will test whether a tailored smartphone app plus nicotine patches and gum helps people living with HIV quit smoking better than a standard quit app.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT06883097

• tDCS plus varenicline to help people quit smoking

  This will test if adding noninvasive tDCS brain stimulation to varenicline helps adults who smoke at least 8 cigarettes a day quit and stay smoke-free.

  Recruiting Phase 4 Centre for Addiction and Mental Health · Toronto, Ontario · NCT06798324

• Smoky Futures: Danish Adolescent Nicotine Use over Time

  This observational cohort follows Danish youths ages 15–25 to see how cigarette, e-cigarette, and other nicotine use begin, change, and affect health and education over several years.

  Recruiting University of Southern Denmark · Copenhagen · NCT07910331

• Nicotine Orodispersible Tablet to Relieve Cravings in Smokers

  A nicotine mint orodispersible tablet is tested vs placebo to see if it quickly eases the urge to smoke in adult cigarette smokers.

  Recruiting Phase 2 Kenvue Brands LLC · Mississauga, Ontario · NCT07893158

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.