This study is not yet accepting patients

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

a study on Smoking Cessation Tobacco

Summary

Eligibility
for people ages 18-65 (full criteria)
Dates
study started
completion around
Principal Investigator
by Lara Ray, PhD

Description

Summary

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.

Official Title

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

Details

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 placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks.

Keywords

Smoking Cessation, Tobacco Use Disorder, smoking cesstion, cigarette smoking, fMRI, cytisinicline

Eligibility

You can join if…

Open to people ages 18-65

  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;

You CAN'T join if...

  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.

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT06617312
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 64 study participants
Last Updated