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2008-09
2012-10
2012-10
315
NCT00790569
Butler Hospital
Butler Hospital
INTERVENTIONAL
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.
OBJECTIVES: Primary * To determine whether varenicline, a nicotine receptor partial agonist, leads to a higher rate of smoking cessation than combination nicotine replacement therapy with nicotine patch prescription plus ad libitum nicotine gum delivery in methadone-maintained smokers. Secondary * To test the effects of the treatments on smoking urges, withdrawal symptoms, and reinforcing effects of smoking. * To test the effects of the treatments on methadone treatment outcomes, including retention in methadone maintenance, methadone dose changes, and continued use of illicit drugs as measured by urine toxicologies. OUTLINE: This is a multicenter study. Patients are stratified based on gender and level of nicotine dependence. Patients are randomized to 1 of 3 intervention arms. At baseline, all patients receive a minimal behavioral intervention using a 3-minute, simple smoking cessation counseling strategy, a self-help manual, and a telephone quit-line number. * Arm I (varenicline): Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. * Arm II (placebo): Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. * Arm III (nicotine patch/gum): Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. Patients complete a brief interview over 10-15 minutes at 2 weeks and monthly during months 1-5. They complete a longer interview over 45 minutes at months 6 and 12 and provide breath samples (for carbon monoxide monitoring) and urine samples (for cotinine testing). NOTE: Smoking cessation may prevent certain smoking-related illnesses, including cancer. PROJECTED ACCRUAL: A total of 602 patients (258 receiving varenicline, 258 receiving nicotine replacement therapy, and 86 receiving placebo) will be accrued for this study.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2008-11-11 | 2013-12-12 | 2018-05-02 |
2008-11-12 | 2013-12-12 | 2018-06-06 |
2008-11-13 | 2014-02-03 | 2018-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Arm I Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. | DRUG: nicotine
DRUG: varenicline
OTHER: placebo
|
| PLACEBO_COMPARATOR: Arm II Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. | DRUG: nicotine
OTHER: placebo
|
| ACTIVE_COMPARATOR: Arm III Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. | DRUG: nicotine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Self- Reported 7-day Abstinence | Number of participants with self-reported, 7-day abstinence at 6-months | 6 Months |
| Carbon Monoxide (CO)-Confirmed 7-day Abstinence | Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement. | 6-Months |
| Rates of Smoking Cessation Continuous From First Quit Day to 6 Months | Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months | 6-Months |
| Self-reported 7-day Abstinence | Number of participants with self-reported 7-day abstinence at 12-months | 12 Months |
| CO-confirmed 7-day Abstinence | Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement. | 12 Months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in Smoking Urges | Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score. | 6 months |
| Withdrawal Symptoms | Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score. | 6 months |
| Retention in Methadone Maintenance | 12 months | |
| Methadone Dose Changes | 12 months | |
| Use of Illicit Drugs as Measured by Urine Toxicologies | 12 months | |
| Reinforcing Effects of Smoking | Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score. | 6 months |
| Change in Cigarettes Per Day | Change in mean cigarettes per day | 6-Months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
