Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

NCT ID: NCT00278226

Last Updated: 2010-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unspecified Adult Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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smoking cessation intervention

Intervention Type BEHAVIORAL

educational intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Butler Hospital

Principal Investigators

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Michael Stein, MD

Role: STUDY_CHAIR

Rhode Island Hospital

Locations

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Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R01CA084392

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RIH-0076-98

Identifier Type: -

Identifier Source: secondary_id

CDR0000452798

Identifier Type: -

Identifier Source: org_study_id

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