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Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

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ClinicalTrials.gov Identifier: NCT00278226
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : March 24, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Butler Hospital

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : June 2001
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Nicotine Abstinence [ Time Frame: 6-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278226


Locations
United States, Rhode Island
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

Responsible Party: Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier: NCT00278226     History of Changes
Other Study ID Numbers: CDR0000452798
R01CA084392 ( U.S. NIH Grant/Contract )
RIH-0076-98
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by Butler Hospital:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents