A Phase 2 interventional study of Varenicline and Placebo in Nicotine Dependence, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-18.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Treatment
The investigators hypothesize that varenicline will dose dependently attenuate the subjective effects of cigarettes after a period of abstinence. Also, treatment with varenicline will dose dependently weaken the severity of nicotine withdrawal symptoms. Thirdly, we hypothesize that treatment with varenicline will dose dependently decrease cigarette self-administration in the model proposed.
Tobacco use is the leading preventable cause of death in the U.S.A. Every year 400,000 people die from cigarette smoking and in 2006, one out of every five deaths in the US were smoking related. Recent advances in laboratory studies of tobacco effects in humans and in understanding the effects of nicotine on the brain and behavior present an opportunity to advance medication development.
The addictive properties of nicotine are thought to be a result of nicotine triggering the acute release of dopamine, a pleasurable event that a person seeks to repeat. Varenicline is a partial agonist of the nicotine receptors, therefore also triggering the release of dopamine but in a more sustained and moderate manner, which could counter the low dopamine levels arising from a lack of nicotine and therefore aid craving. Also, by binding to these nicotine receptors in advance of smoking, it could stop nicotine from binding and creating pleasurable effects.
This study will assess the effect of acute treatment with varenicline and placebo on early tobacco withdrawal, acute effects of cigarettes and cigarette self-administration in cigarette-smoking volunteers. After overnight abstinence, participants will come into the lab and receive acute treatment with varying doses of varenicline or placebo and perform computer tests and fill out questionnaires. Then they will be given the opportunity to smoke under operational conditions (cigarette versus money choice). This study will employ a within-group, double-blind, randomized and counterbalanced design.
The main goal of this project is to improve the current laboratory model of smoking cessation and study the mechanism involved in smoking maintenance. We hypothesize that varenicline will dose-dependently: 1) decrease nicotine withdrawal symptoms, 2) decrease acute effects of cigarettes and 3) decrease self-administration of cigarettes in the laboratory paradigm. Showing the effectiveness of varenicline in the proposed laboratory model will confirm the model's predictive validity to detect clinically effective medication.
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This study's enrollment of 16 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
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Exclusion Criteria:
Each participant participates in 4 consecutive interventions in random order. 1. Placebo, 1 capsule before the session 2. 0.5 mg varenicline, 1 capsule before the session 3.1 mg varenicline, 1 capsule before the session 4. 2 mg varenicline, 1 capsule before the session
Drug: Varenicline · Drug: Placebo
Each participant participates in 4 consecutive interventions in random order. 1.0.5 mg varenicline, 1 capsule before the session 2. 1 mg varenicline, 1 capsule before the session 3.2 mg varenicline, 1 capsule before the session 4. Placebo, 1 capsule before the session
Drug: Varenicline · Drug: Placebo
Each participant participates in 4 consecutive interventions in random order. 1.1 mg varenicline, 1 capsule before the session 2. 2 mg varenicline, 1 capsule before the session 3.Placebo, 1 capsule before the session 4. 0.5 mg varenicline, 1 capsule before the session
Drug: Varenicline · Drug: Placebo
Each participant participates in 4 consecutive interventions in random order. 1.2 mg varenicline, 1 capsule before the session 2. Placebo, 1 capsule before the session 3. 0.5 mg varenicline, 1 capsule before the session 4. 1 mg varenicline, 1 capsule before the session
Drug: Varenicline · Drug: Placebo
4 doses of Varenicline. 1 capsule of either dose (0mg, 0.5mg, 1mg, 2 mg) in the morning on days at least 5 days apart.
Also known as: Chantix
1 dose of placebo
Cigarette Choice
Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.
Time frame: During each of the four weekly 6-hour experimental sessions
Twenty-one participants were recruited in an urban hospital setting through advertisement in local newspapers and flyers and 16 particiopants were enrolled. Study was conducted at the NYS Psychiatric Institute
| Milestone | Study Participants |
|---|---|
| Started | 16 |
| Received placebo | 16 |
| Received varenicline 0.5 mg | 16 |
| Received varenicline 1.0 mg | 16 |
| Received varenicline 2.0 mg | 16 |
| Completed | 16 |
| Not completed | 0 |
Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.
| number of cigarette choices (0-9) | Placebo | Varenicline 0.5 mg | Varenicline 1.0 mg | Varenicline 2.0 mg |
|---|---|---|---|---|
| Cigarette Choice | 3.67 ± 0.51 | 3.17 ± 0.63 | 2.83 ± 0.71 | 2.83 ± 0.55 |
Collected over Adverse events reported during 4 experimental sessions. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | — | 0/16 (0%) | 0/16 (0%) |
| Age, Continuous(years) | Study Participants |
|---|---|
| Mean | 36.5 (23 to 44) |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 4 |
| Male | 12 |
| Race (NIH/OMB)(Participants) | Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 10 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Study Participants |
|---|---|
| United States | 16 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute