Effects of Cytisinicline on Smoking Cues in Daily Smokers
Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-Reactivity
This study tests if a medication called cytisinicline can help daily smokers reduce their cravings and reactions to cigarette-related triggers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06617312 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who smoke at least 5 cigarettes daily and are not currently seeking treatment for smoking cessation.
Not a fit: Patients who are actively using other smoking cessation aids or have a recent history of substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved smoking cessation strategies by targeting neural responses to smoking cues.
How similar studies have performed: Other studies have shown promise in using pharmacological interventions to modify cue-reactivity in smokers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.