Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

• Sponsor: Butler Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00278226
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 398
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief Summary

RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.

PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.

Condition or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Behavioral: smoking cessation intervention; Other: educational intervention	N/A

Detailed Description

OBJECTIVES:

• Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.

OUTLINE: Patients are assigned to 1 of 2 groups.

• Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.

• Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.

All patients will be offered a 2- to 3-month supply of nicotine patches.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 398 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Smoking Cessation Among Methadone Maintained Patients
• Study Start Date: Jun 1, 2001
• Actual Primary Completion Date: Oct 1, 2004
• Actual Study Completion Date: Oct 1, 2004

Outcome Measures

Primary Outcome Measures

1. Nicotine Abstinence [6-months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Must be currently enrolled in a methadone maintenance program

• Smokes at least 10 cigarettes a day

PATIENT CHARACTERISTICS:

• Not pregnant

• No concurrent medical condition that precludes the use of nicotine patches

PRIOR CONCURRENT THERAPY:

• No concurrent use of other nicotine replacement therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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, Rhode Island Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00278226
• Other Study ID Numbers: CDR0000452798; R01CA084392; RIH-0076-98
• First Posted: Jan 18, 2006
• Last Update Posted: Mar 24, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: unspecified adult solid tumor, protocol specific

Study Results

No Results Posted as of Mar 24, 2010