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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Randomized Study of Varenicline Versus Combination Nicotine Replacement Therapy Using Nicotine Patch and Gum in Smokers Participating in a Methadone Maintenance Treatment Program

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Behavioral study, Prevention Active Over 18 Other BUTLER-0807-004 0807-004, NCT00790569

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Have smoked more than 10 cigarettes a day for the past 3 months
• Participate in a methadone treatment program in Rhode Island at Codac, Inc., Addiction Recovery Institute, Center for Treatment and Recovery, or Discovery House
• Have received methadone for at least the last month
• Speak English
• Have access to a telephone
• Available for this study for the next year
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be randomly assigned (have an equal chance of being placed) to one of three groups.

At the beginning of the study, all participants will receive brief stop-smoking counseling, a self-help manual, and a telephone quit-line number.

Participants in group one will receive varenicline by mouth once a day for 3 days and then twice a day for approximately 6 months.

Participants in group two will receive a placebo by mouth once a day for 3 days and then twice a day for approximately 6 months.

Participants in group three will receive a nicotine patch for 26 weeks. They will also receive nicotine gum as needed. Treatment may continue for as long as benefit is shown.

Participants will be interviewed briefly at 2 weeks and then once a month for 5 months. At 6 months and 1 year, they will undergo a longer interview and provide breath and urine samples.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Butler Hospital

Michael Stein, MD, Protocol chair		Ph: 401-455-6000

U.S.A.
Rhode Island
	Providence
	Rhode Island Hospital Comprehensive Cancer Center
		Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center	Ph:  401-444-1488

Registry Information
Official Title		Varenicline versus Nicotine Replacement for Methadone-Maintained Smokers
Trial Start Date		2008-09-01
Trial Completion Date		2013-08-31 (estimated)
Registered in ClinicalTrials.gov		NCT00790569
Date Submitted to PDQ		2008-11-07
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CA129226