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

Trial Information

Current as of October 07, 2024

Not yet recruiting

Keywords

Smoking Cesstion Tobacco Use Disorder Cigarette Smoking F Mri Cytisinicline

Description

The objective of this study is to examine the effects of cytisinicline on neural substrates of cigarette cue-reactivity. We will randomize 64 adults who smoke cigarettes daily (N=32 cytisinicline, N=32 placebo; 50% female) into a double-blind, placebo-controlled laboratory study of cytisinicline. Specifically, participants will complete a 2- to 3-week outpatient protocol that includes taking cytisinicline (3 mg, 3 times daily) or matched placebo (0 mg, 3 times daily) and completing a brief daily diary assessment of cigarette use and craving. Following 2- to 3-weeks of cytisinicline (or plac...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. be between the ages of 18 and 65 and provide informed consent;
  • 2. smoke 10 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. serious medical illness within past 6 months;
  • 8. have a medical condition that may interfere with safe study participation.
  • 9. renal impairment defined as a creatinine clearance (CrCl) greater than 60 mL/min (estimated with the Cockroft-Gault equation).
  • 10. non-removable ferromagnetic object in body;
  • 11. claustrophobia;
  • 12. serious head injury or period of unconsciousness (more than 30 minutes);
  • 13. more than 250lbs;
  • 14. pregnancy, nursing, or refusal to use reliable birth control if female;
  • 15. have experienced adverse effects to varenicline.

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.

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Timeline

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Trial launched

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Estimated completion

Not reported

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