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

Lung Cancer Clinical Trial

Official title:

Varenicline Versus Nicotine Replacement for Methadone-Maintained Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00790569
• Other study ID #: CDR0000616663
• Secondary ID: R01CA129226BUTLE
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: October 2012

Study information

• Verified date: May 2018
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Cervical Cancer
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Kidney Cancer
• Kidney Neoplasms
• Leukemia
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Lung Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms
• Tobacco Use Disorder
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms

Intervention

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

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self- Reported 7-day Abstinence	Number of participants with self-reported, 7-day abstinence at 6-months	6 Months
Primary	Carbon Monoxide (CO)-Confirmed 7-day Abstinence	Number of participants reporting 7-day abstinence at 6-months, confirmed with CO measurement.	6-Months
Primary	Rates of Smoking Cessation Continuous From First Quit Day to 6 Months	Number of participants who self-reported continuous abstinence from their initial quit day (study day 14) to 6 Months	6-Months
Primary	Self-reported 7-day Abstinence	Number of participants with self-reported 7-day abstinence at 12-months	12 Months
Primary	CO-confirmed 7-day Abstinence	Number of participants reporting 7-day abstinence at 12-months, confirmed with CO measurement.	12 Months
Secondary	Change in Smoking Urges	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
Secondary	Withdrawal Symptoms	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
Secondary	Retention in Methadone Maintenance		12 months
Secondary	Methadone Dose Changes		12 months
Secondary	Use of Illicit Drugs as Measured by Urine Toxicologies		12 months
Secondary	Reinforcing Effects of Smoking	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
Secondary	Change in Cigarettes Per Day	Change in mean cigarettes per day	6-Months