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Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278226
First Posted: January 18, 2006
Last Update Posted: March 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Butler Hospital
  Purpose

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 Intervention
Unspecified Adult Solid Tumor, Protocol Specific Behavioral: smoking cessation intervention Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Smoking Cessation Among Methadone Maintained Patients

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

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

Enrollment: 398
Study Start Date: June 2001
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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 Submitted: January 16, 2006
First Posted: January 18, 2006
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