Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

Butler Hospital

Status: Completed

Conditions: Tobacco Use Disorder; Bladder Cancer; Gastric Cancer; Esophageal Cancer; Lung Cancer; Kidney Cancer; Leukemia; Head and Neck Cancer; Liver Cancer; Cervical Cancer; Pancreatic Cancer

Treatments: Drug: varenicline; Drug: nicotine; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00790569

BUTLER-0807-004

CDR0000616663

R01CA129226 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 315 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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315 participants in 3 patient groups, including a placebo group

Arm I

Experimental group

Description:

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.

Treatment:

Drug: varenicline

Arm II

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo

Arm III

Active Comparator group

Description:

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.

Treatment:

Drug: nicotine