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New treatment option for Smoking Cessation
Official title Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity
ClinicalTrials.gov ID: NCT06617312
What this study is testing
What is Cytisinicline?
Cytisinicline is an investigational medicine, given as an once-daily, being studied as a potential treatment for smoking cessation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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...
- lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;
See the full eligibility criteria
- 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;
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.