Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Progra… (NCT00790569) | Clinical Trial Compass
CompletedNot Applicable
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
United States315 participantsStarted 2008-09
Plain-language summary
RATIONALE: Varenicline, the nicotine patch, and nicotine gum help people stop smoking. It is not yet known whether varenicline is more effective than the nicotine patch given together with nicotine gum in helping smokers quit smoking.
PURPOSE: This randomized clinical trial is studying varenicline to see how well it works compared with the nicotine patch given together with nicotine gum in helping smokers in a methadone treatment program stop smoking.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* Current and regular cigarette smokers (over 10 cigarettes/day for the past 3 months)
* Interested in quitting smoking
* Willing to set a quit date 7 days after baseline assessment
* Participating in 1 of 5 methadone maintenance treatment programs across Rhode Island at any of the following institutions:
* Codac, Inc. (with two independent sites)
* Addiction Recovery Institute
* Center for Treatment and Recovery
* Discovery House
* Has received methadone for at least the past month
EXCLUSION CRITERIA
* Pregnant or nursing (Must have negative pregnancy test)
* Non-English speaking
* No personal telephone or does not live close to a relative or neighbor with a telephone
* Unwilling to make their methadone dose and methadone maintenance treatment program urine toxicologies available for review
* Unvailable for this study for the next 12 months
* Suffering from any unstable medical condition which would preclude the use of the nicotine patch (e.g., unstable angina or uncontrolled hypertension)
* Active skin condition (e.g., psoriasis)
* History of skin allergy
* History of a suicide attempt
* Working as pilots, drivers, or operators of heavy machinery
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No concurrent insulin or blood thinners
* No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking cessation treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self- Reported 7-day Abstinence
Timeframe: 6 Months
2
Carbon Monoxide (CO)-Confirmed 7-day Abstinence
Timeframe: 6-Months
3
Rates of Smoking Cessation Continuous From First Quit Day to 6 Months