Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
NCT00790569 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315
Last updated 2018-06-06
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.
Conditions
- Bladder Cancer
- Cervical Cancer
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Cancer
- Kidney Cancer
- Leukemia
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- Tobacco Use Disorder
Interventions
- DRUG
-
nicotine
Given transdermally and orally
- DRUG
-
varenicline
Given orally
- OTHER
-
placebo
Given orally
Sponsors & Collaborators
-
Butler Hospital
lead OTHER -
National Cancer Institute (NCI)
collaborator NIH
Principal Investigators
-
Michael Stein, MD · Butler Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2012-10-31
- Completion
- 2012-10-31
Countries
- United States
Study Locations
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