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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT00790569
First received: November 11, 2008
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
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
Drug: varenicline
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Rates of smoking cessation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 602
Study Start Date: September 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: varenicline
Given orally
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.
 Other: placebo
Given orally
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.
 Drug: nicotine
Given transdermally and orally

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790569

Locations
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
National Cancer Institute (NCI)
Investigators
Study Chair: Michael Stein, MD Butler Hospital
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT00790569     History of Changes
Other Study ID Numbers: CDR0000616663, R01CA129226, BUTLER-0807-004
Study First Received: November 11, 2008
Last Updated: August 1, 2012
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
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

Additional relevant MeSH terms:
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
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013