Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
18 Years
N/A
Both
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder
Trial Information
Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- English speaking
- Has a telephone or lives close to a relative or neighbor with a telephone
- Willing to make their methadone dose and methadone maintenance treatment program
urine toxicologies available for review
- Available for this study for the next 12 months
- Not suffering from any unstable medical condition which would preclude the use of the
nicotine patch (e.g., unstable angina or uncontrolled hypertension)
- No active skin condition (e.g., psoriasis)
- No history of skin allergy
- No history of a suicide attempt
- Not 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Rates of smoking cessation
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Michael Stein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Butler Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000616663
NCT ID:
NCT00790569
Start Date:
September 2008
Completion Date:
December 2012
Related Keywords:
- Bladder Cancer
- Cervical Cancer
- Esophageal Cancer
- Gastric Cancer
- Head and Neck Cancer
- Kidney Cancer
- Leukemia
- Liver Cancer
- Lung Cancer
- Pancreatic Cancer
- Tobacco Use Disorder
- bladder cancer
- cervical cancer
- esophageal cancer
- gastric cancer
- renal cell carcinoma
- adult primary liver cancer
- non-small cell lung cancer
- small cell lung cancer
- pancreatic cancer
- hypopharyngeal cancer
- laryngeal cancer
- lip and oral cavity cancer
- nasopharyngeal cancer
- oropharyngeal cancer
- paranasal sinus and nasal cavity cancer
- adult acute myeloid leukemia
- tobacco use disorder
- Urinary Bladder Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Uterine Cervical Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Head and Neck Neoplasms
- Leukemia
- Liver Neoplasms
- Lung Neoplasms
- Stomach Neoplasms
- Pancreatic Neoplasms
- Tobacco Use Disorder
Name | Location |
|---|---|
| Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
