- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00790569
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
Given transdermally and orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self- Reported 7-day Abstinence
Time Frame: 6 Months
|
Number of participants with self-reported, 7-day abstinence at 6-months
|
6 Months
|
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.
|
6-Months
|
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
|
6-Months
|
Self-reported 7-day Abstinence
Time Frame: 12 Months
|
Number of participants with self-reported 7-day abstinence at 12-months
|
12 Months
|
CO-confirmed 7-day Abstinence
Time Frame: 12 Months
|
Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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.
|
6 months
|
Retention in Methadone Maintenance
Time Frame: 12 months
|
12 months
|
|
Methadone Dose Changes
Time Frame: 12 months
|
12 months
|
|
Use of Illicit Drugs as Measured by Urine Toxicologies
Time Frame: 12 months
|
12 months
|
|
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.
|
6 months
|
Change in Cigarettes Per Day
Time Frame: 6-Months
|
Change in mean cigarettes per day
|
6-Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Michael Stein, MD, Butler Hospital
Publications and helpful links
General Publications
- Stein MD, Caviness CM, Kurth ME, Audet D, Olson J, Anderson BJ. Varenicline for smoking cessation among methadone-maintained smokers: a randomized clinical trial. Drug Alcohol Depend. 2013 Dec 1;133(2):486-93. doi: 10.1016/j.drugalcdep.2013.07.005. Epub 2013 Aug 14.
- de Dios MA, Anderson BJ, Caviness CM, Stein M. Intimate partner violence among individuals in methadone maintenance treatment. Subst Abus. 2014;35(2):190-3. doi: 10.1080/08897077.2013.835764.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- non-small cell lung cancer
- esophageal cancer
- bladder cancer
- gastric cancer
- pancreatic cancer
- renal cell carcinoma
- small cell lung cancer
- cervical cancer
- oropharyngeal cancer
- laryngeal cancer
- hypopharyngeal cancer
- adult primary liver cancer
- lip and oral cavity cancer
- nasopharyngeal cancer
- paranasal sinus and nasal cavity cancer
- adult acute myeloid leukemia
- tobacco use disorder
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Substance-Related Disorders
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Liver Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Pancreatic Diseases
- Uterine Cervical Neoplasms
- Stomach Neoplasms
- Lung Neoplasms
- Tobacco Use Disorder
- Urinary Bladder Neoplasms
- Pancreatic Neoplasms
- Liver Neoplasms
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
- Varenicline
Other Study ID Numbers
- CDR0000616663
- R01CA129226 (U.S. NIH Grant/Contract)
- BUTLER-0807-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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