Smoking CessationPhase 2CytisiniclineNCT06617312
Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity
A Phase 2 study testing Cytisinicline in people with Smoking Cessation and Tobacco Use Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder
- What is being tested?
- Cytisinicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be between the ages of 18 and 65 and provide informed consent;
- smoke 5 or more combustible cigarettes per day;
- not seeking treatment for smoking;
Who cannot join
- current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT);
- more than 3 months of smoking abstinence in past year;
- use of non-cigarette tobacco product (pipe tobacco, cigars, smokeless tobacco, hookah) or electronic cigarettes more than 5 times in the 28-days prior to enrollment;
- current use of psychoactive drug (excluding cannabis), as determined by urine toxicology;
- current (past 12-month) DSM-5 diagnosis of substance use disorder for any substances other than tobacco and mild cannabis or mild-to-moderate alcohol use disorders;
- lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;
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- current suicidal ideation or lifetime history of suicide attempt;
- 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;
- medical condition that may interfere with safe study participation;
- renal impairment defined as a creatinine clearance (CrCl) greater than 60 mL/min (estimated with the Cockroft-Gault equation);
- 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";
- uncontrolled hypertension (blood pressure ≥160/100 mmHg);
- abnormal electrocardiogram;
- non-removable ferromagnetic object in body;
- claustrophobia;
- serious head injury or period of unconsciousness (more than 30 minutes);
- more than 250lbs;
- 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;
- have experienced adverse effects to varenicline;
- have an intense fear of needles or have had an adverse reaction to needle puncture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90049
Dylan E Kirsch, PhD, 310-206-6756, dylankirsch@psych.ucla.edu
About this study
Official title: Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-Reactivity
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.
Read the detailed 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 placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks.
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Being tested
- Cytisinicline, Placebo Oral Capsule
- Keywords
- smoking cesstion, tobacco use disorder, cigarette smoking, fMRI, cytisinicline
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytisiniclineDrug
Targets α4β2 nicotinic acetylcholine receptors
Placebo Oral CapsuleDrug
Matched to active drug, cytisinicline
| Study group | Role | What they receive |
|---|---|---|
| Cytisinicline | Experimental | 3mg cytisinicline oral capsule 3 times daily for 2-to-3 weeks Receives: Drug: Cytisinicline |
| Placebo | Placebo comparator | matched to experimental drug Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task
Participants will complete a cigarette cue-exposure task during fMRI. In this paradigm, participants are exposed to videotaped cues of smoking and control, non-cigarette related, content. Blood-oxygen-level-dependent (BOLD) activation to cigarette (vs. non-cigarette control ) cues will be calculated.
Measured: From enrollment to end of treatment at 2-to-3 weeks
Secondary outcomes (2)
In-scanner cigarette cue-induced subjective craving
In-scanner cigarette cue-induced subjective craving ratings will be obtained following each cue exposure during the fMRI task.
Measured: From enrollment to end of treatment at 2-to-3 weeks
Subjective cigarette craving during outpatient period
Subjective cigarette craving, as assessed via daily diary self-report assessments, during the outpatient medication period
Measured: From enrollment to end of treatment at 2-to-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start5 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will randomize 64 non-treatment seeking adults who smoke cigarettes (N=32 cytisinicline, N=32 placebo; 50% females) in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity. All participants will be daily combustible cigarette smokers. Interested individuals will call the lab and complete a telephone screening interview. Individuals who are deemed eligible will receive a full explanation of study procedures and provide written, informed consent. Participants will then complete a behavioral screen and physical exam. Eligible participants will then be randomized to a medication, cytisinicline (3 mg, 3 times daily) or placebo (0mg, 3 times daily). Participants will complete brief daily diary self-reports of cigarette use and craving during the outpatient medication period. Following 2- to 3-weeks of cytisinicline, or placebo, treatment participants will complete a cigarette cue-exposure fMRI task.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Ray, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617312
- Sponsor's protocol ID
- 24-001071
- Other IDs
- T34FT8089
- Acronym
- Cytisinicline
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-Reactivity
- ClinicalTrials.gov ID
- NCT06617312
- Acronym / sponsor ID
- Cytisinicline / 24-001071
- Conditions
- Smoking Cessation, Tobacco Use Disorder
- Keywords
- smoking cesstion, tobacco use disorder, cigarette smoking, fMRI, cytisinicline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- We will randomize 64 non-treatment seeking adults who smoke cigarettes (N=32 cytisinicline, N=32 placebo; 50% females) in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity. All participants will be daily combustible cigarette smokers. Interested individuals will call the lab and complete a telephone screening interview. Individuals who are deemed eligible will receive a full explanation of study procedures and provide written, informed consent. Participants will then complete a behavioral screen and physical exam. Eligible participants will then be randomized to a medication, cytisinicline (3 mg, 3 times daily) or placebo (0mg, 3 times daily). Participants will complete brief daily diary self-reports of cigarette use and craving during the outpatient medication period. Following 2- to 3-weeks of cytisinicline, or placebo, treatment participants will complete a cigarette cue-exposure fMRI task.
| Arm | Type | Receives |
|---|---|---|
| Cytisinicline | Experimental | Drug: Cytisinicline3mg cytisinicline oral capsule 3 times daily for 2-to-3 weeks |
| Placebo | Placebo comparator | Drug: Placebo Oral Capsulematched to experimental drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be between the ages of 18 and 65 and provide informed consent;
- smoke 5 or more combustible cigarettes per day;
- not seeking treatment for smoking;
Key exclusion criteria (29 listed)
- current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT);
- more than 3 months of smoking abstinence in past year;
- use of non-cigarette tobacco product (pipe tobacco, cigars, smokeless tobacco, hookah) or electronic cigarettes more than 5 times in the 28-days prior to enrollment;
- current use of psychoactive drug (excluding cannabis), as determined by urine toxicology;
- current (past 12-month) DSM-5 diagnosis of substance use disorder for any substances other than tobacco and mild cannabis or mild-to-moderate alcohol use disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytisiniclineTargets α4β2 nicotinic acetylcholine receptors | Drug | Cytisinicline |
| Placebo Oral CapsuleMatched to active drug, cytisinicline | Drug | Placebo |
Primary outcome
Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task
Time frame: From enrollment to end of treatment at 2-to-3 weeks
Participants will complete a cigarette cue-exposure task during fMRI. In this paradigm, participants are exposed to videotaped cues of smoking and control, non-cigarette related, content. Blood-oxygen-level-dependent (BOLD) activation to cigarette (vs. non-cigarette control ) cues will be calculated.
2 secondary outcomes
In-scanner cigarette cue-induced subjective craving
Time frame: From enrollment to end of treatment at 2-to-3 weeks
Subjective cigarette craving during outpatient period
Time frame: From enrollment to end of treatment at 2-to-3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytisinicline in people with Smoking Cessation and Tobacco Use Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dylan E Kirsch, PhD ((310) 206-6756, dylankirsch@psych.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task (time frame: From enrollment to end of treatment at 2-to-3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.