RECRUITING

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

Conditions

Smoking Cessation Tobacco Use Disorder smoking cesstion cigarette smoking fMRI cytisinicline

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-01

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06617312

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;	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.

Inclusion Criteria

Exclusion 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;

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.

Contacts and Locations

Study Contact

Dylan E Kirsch, PhD

CONTACT

(310) 206-6756

dylankirsch@psych.ucla.edu

Study Locations (Sites)

University of California Los Angeles

Los Angeles, California, 90049

United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-01

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

smoking cesstion
tobacco use disorder
cigarette smoking
fMRI
cytisinicline

Additional Relevant MeSH Terms

Smoking Cessation
Tobacco Use Disorder