Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
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.
Checked against the public recordLast updated Jun 6, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Butler Hospital
- Interventions being studied
- Drug: nicotine; Drug: varenicline; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 6, 2018. Always confirm current availability with the study team.