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

Official Title: “Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers”

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.

Intervention(s) in this Clinical Trial

• Drug: nicotine
  • Given transdermally and orally
• Drug: varenicline
  • Given orally
• Other: placebo
  • Given orally

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.
• 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.

Primary Measures

• Rates of smoking cessation
  • Time Frame: 12 months
    Safety Issue?: No

Secondary Measures

• Smoking urges
  • Time Frame: 12 months
    Safety Issue?: No
• Withdrawal symptoms
  • Time Frame: 12 months
    Safety Issue?: No
• Retention in methadone maintenance
  • Time Frame: 12 months
    Safety Issue?: No
• Methadone dose changes
  • Time Frame: 12 months
    Safety Issue?: No
• Use of illicit drugs as measured by urine toxicologies
  • Time Frame: 12 months
    Safety Issue?: No
• Reinforcing effects of smoking
  • Time Frame: 12 months
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Butler Hospital Other

Overall Clinical Trial Officials and Contacts

Michael Stein, MD Study Chair Butler Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00790569

Study ID Number: CDR0000616663

ClinicalTrials.gov Identifier: NCT00790569

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database