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Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

18 Years
Open (Enrolling)
Bladder Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer, Head and Neck Cancer, Kidney Cancer, Leukemia, Liver Cancer, Lung Cancer, Pancreatic Cancer, Tobacco Use Disorder

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Trial Information

Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers



- 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.


- 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


- 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


- 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


- See Disease Characteristics

- No concurrent insulin or blood thinners

- No concurrent smokeless tobacco, nicotine replacement therapy, or other smoking
cessation treatment

Type of Study:


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:


Principal Investigator

Michael Stein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Butler Hospital


United States: Federal Government

Study ID:




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



Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903