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Completed

NCT Number: NCT00790569

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

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.

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Key information

Conditions

Bladder Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cervical Cancer Chemically-Induced Disorders Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Cancer Head and Neck Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hypopharyngeal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Laryngeal Diseases Laryngeal Neoplasms Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Mental Disorders Mouth Diseases Mouth Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Substance-Related Disorders Thoracic Neoplasms Tobacco Use Disorder Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nicotine

Drug

Given transdermally and orally

Varenicline

Drug

Given orally

Placebo

Other

Given orally

Primary outcomes

  1. Self- Reported 7-day Abstinence

    Time frame: 6 Months

    Number of participants with self-reported, 7-day abstinence at 6-months

  2. Carbon Monoxide (CO)-Confirmed 7-day Abstinence

    Time frame: 6-Months

    Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.

  3. Rates of Smoking Cessation Continuous From First Quit Day to 6 Months

    Time frame: 6-Months

    Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months

  4. Self-reported 7-day Abstinence

    Time frame: 12 Months

    Number of participants with self-reported 7-day abstinence at 12-months

  5. CO-confirmed 7-day Abstinence

    Time frame: 12 Months

    Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.

Secondary outcomes

  1. Change in Smoking Urges

    Time frame: 6 months

    Smoking urges was measured on a 0 (not at all) - 100 (strongest feeling possible) scale. Higher values represent greater urge to smoke. Change in smoking urges was calculated as Follow-up score (6 month) - Baseline Score.

  2. Withdrawal Symptoms

    Time frame: 6 months

    Withdrawal Symptoms were measured using a modified version of the Minnesota Behavior Rating Scale. The scale asked subjects to rate their smoking withdrawal symptoms over the previous 24 hours on a scale from 0 (none) to 4 (severe). Higher values indicate more severe withdrawal symptoms. Change in withdrawal symptoms was calculated as Follow-up score (6 month) - Baseline Score.

  3. Retention in Methadone Maintenance

    Time frame: 12 months

  4. Methadone Dose Changes

    Time frame: 12 months

  5. Use of Illicit Drugs as Measured by Urine Toxicologies

    Time frame: 12 months

  6. Reinforcing Effects of Smoking

    Time frame: 6 months

    Reinforcing effects of smoking was measured using the modified version of the Cigarette Evaluation Questionnaire. Participants were asked to indicate on a 12-item scale how smoking made them feel in the prior 30 days on a scale from 1 (Not at all) to 7 (Extremely). Higher values indicated that smoking was a more positive experience for 10 of 12 items. Two items were reverse coded. Change in reinforcing effects of smoking was calculated as Follow-up score (6 month) - Baseline Score.

  7. Change in Cigarettes Per Day

    Time frame: 6-Months

    Change in mean cigarettes per day

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 13, 2008
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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