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Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00278226
First received: January 16, 2006
Last updated: March 23, 2010
Last verified: March 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Smoking Cessation Among Methadone Maintained Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Nicotine Abstinence [ Time Frame: 6-months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier: NCT00278226     History of Changes
Other Study ID Numbers: CDR0000452798, R01CA084392, RIH-0076-98
Study First Received: January 16, 2006
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 23, 2013