Search / Trial NCT06617312

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

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Sep 24, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Smoking Cesstion Tobacco Use Disorder Cigarette Smoking F Mri Cytisinicline

ClinConnect Summary

This clinical trial is studying a medication called cytisinicline to see how it affects people's reactions to cigarette-related cues, which are things that might make someone want to smoke. The study is looking for 64 adults aged 18 to 65 who smoke at least five cigarettes a day but are not currently trying to quit smoking. Participants will be randomly assigned to receive either the medication or a placebo (a pill that looks the same but has no active ingredients) in a controlled laboratory setting.

To be eligible, you must be a daily smoker, within the age range, and willing to provide consent to participate. However, if you've recently tried to quit smoking using other medications, have a history of certain medical or mental health conditions, or are pregnant or nursing, you may not qualify. If you join the study, you can expect to participate in tests that help researchers understand how the medication works in the brain when exposed to smoking cues. This trial is currently recruiting participants, and it aims to gather important information that could help people quit smoking in the future.

Gender

ALL

Eligibility 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 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.

About University Of California, Los Angeles

The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.

Locations

Los Angeles, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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