Summary

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

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 University of California Health

  • Lara Ray, PhD (ucla)
    Professor, Psychology, College of Letters and Science. Authored (or co-authored) 274 research publications

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