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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT00790569
First received: November 11, 2008
Last updated: December 12, 2013
Last verified: December 2013

November 11, 2008
December 12, 2013
September 2008
October 2012   (final data collection date for primary outcome measure)
  • 7-day Abstinence, Self-report [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Rates of self-reported 7-day abstinence at 6-months
  • 7-day Abstinence, CO-confirmed [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
    Rates of CO-confirmed 7-day abstinence at 6-months
  • Rates of Smoking Cessation Continuous [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
    Rates of self-reported continuous abstinence 6 Months
  • 7-day Abstinence, Self-reported [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Rates of self-reported 7-day abstinence at 12-months
  • 7-day Abstinence, CO-confirmed [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Rates of CO-confirmed 7-day abstinence at 12-months
Rates of smoking cessation [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00790569 on ClinicalTrials.gov Archive Site
  • Smoking Urges [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Withdrawal Symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Retention in Methadone Maintenance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Methadone Dose Changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Use of Illicit Drugs as Measured by Urine Toxicologies [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reinforcing Effects of Smoking [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Reduction in Cigarettes Per Day [ Time Frame: 6-Months ] [ Designated as safety issue: No ]
    Change in mean cigarettes per day
  • Smoking urges [ Designated as safety issue: No ]
  • Withdrawal symptoms [ Designated as safety issue: No ]
  • Reinforcing effects of smoking [ Designated as safety issue: No ]
  • Retention in methadone maintenance [ Designated as safety issue: No ]
  • Methadone dose changes [ Designated as safety issue: No ]
  • Use of illicit drugs as measured by urine toxicologies [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Bladder Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Head and Neck Cancer
  • Kidney Cancer
  • Leukemia
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • Tobacco Use Disorder
  • Drug: nicotine
    Given transdermally and orally
  • Drug: varenicline
    Given orally
  • Other: placebo
    Given orally
  • 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.
    Intervention: Drug: varenicline
  • 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.
    Intervention: Other: placebo
  • 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.
    Intervention: Drug: nicotine
Caviness CM, Bird JL, Anderson BJ, Abrantes AM, Stein MD. Minimum recommended physical activity, and perceived barriers and benefits of exercise in methadone maintained persons. J Subst Abuse Treat. 2013 Apr;44(4):457-62. doi: 10.1016/j.jsat.2012.10.002. Epub 2012 Nov 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00790569
CDR0000616663, R01CA129226, BUTLER-0807-004
Yes
Michael Stein, MD, Butler Hospital
Butler Hospital
National Cancer Institute (NCI)
Study Chair: Michael Stein, MD Butler Hospital
Butler Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP