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Working Inside for Smoking Elimination (WISE)

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ClinicalTrials.gov Identifier: NCT01122589
Recruitment Status : Unknown
Verified September 2010 by Memorial Hospital of Rhode Island.
Recruitment status was:  Recruiting
First Posted : May 13, 2010
Last Update Posted : September 9, 2010
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Memorial Hospital of Rhode Island

Brief Summary:
The purpose of this study is to determine the extent to which an Intentional Behavioral Intervention will increase tobacco quit rates post release among incarcerated men and women.

Condition or disease Intervention/treatment
Cigarette Smoking Tobacco Smoking Behavioral: Motivational Interviewing/CBT Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)

Detailed Description:
Quitting smoking reduces the risks of developing smoking related illnesses as well as the morbidity and mortality associated with these illnesses. In 2006 approximately 44.5 million American adults smoked an overall prevalence of 20.8%. The prevalence is much higher among incarcerated populations and approximately 80% of the women in RI smoked prior to incarceration. This proposal is designed to evaluate an intervention utilizing Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) to provide the skills necessary to maintain smoking abstinence after release. MI utilizes specific techniques for providing feedback on an individual's risk and self efficacy. CBT provides the skills necessary to maintain abstinence after release. The investigators plan to recruit 350 men and women from the Rhode Island Department of Corrections and randomize them to two interventions: an Intentional Behavioral Intervention (IBI) with 6 sessions of in jail MI/CBT and two post release booster sessions compared to CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL) group which will receive a smoking cessation pamphlet and watch a series of six weekly 30-45 minutes general wellness videos.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sustaining Tobacco Abstinence After Incarceration
Study Start Date : February 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Motivation Interviewing/CBT Behavioral: Motivational Interviewing/CBT
6 sessions of in jail MI/CBT counseling will be administered.
Active Comparator: Control
Receive a smoking cessation pamphlet and watch a series of six weekly 30-45 minutes general wellness videos.
Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)
a series of six weekly 30-45 minutes general wellness videos



Primary Outcome Measures :
  1. Smoking abstinence [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and older
  • Daily smokers over the past 30 non-institutionalized days (prior to Incarceration)
  • Expected place of residence after release within 15 miles of follow-up site
  • Agree to participate in the study protocol and be available within one month post release
  • Speak English
  • Provides at least two pieces of locator information
  • Scheduled to be released within eight weeks

Exclusion Criteria:

  • Inability to give informed consent secondary to organic brain function, not having own legal guardianship, or active psychosis or otherwise not able to participate in the intervention or assessments (deaf, blind, or impaired communication skills that impair ability to participate in computerized assessment or counseling)
  • Housed in a segregation unit

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): NCT01122589


Contacts
Contact: Jennifer G Clarke, MD 401-729-3400 Jennifer_Clarke@mhri.org
Contact: Jennifer A Mello, MPH 401-729-3573 Jennifer_Mello@mhri.org

Locations
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Jennifer G Clarke, MD    401-729-3400    Jennifer_Clarke@mhri.org   
Contact: Jennifer A Mello, MPH    401-729-3573    Jennifer_Mello@mhri.org   
Principal Investigator: Jennifer G Clarke, MD         
Sponsors and Collaborators
Memorial Hospital of Rhode Island
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Jennifer G Clarke, MD Memorial Hospital of Rhode Island

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jennifer G. Clarke, MD MPH, Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01122589     History of Changes
Other Study ID Numbers: WISE 09-21
1R01DA024093-01A2 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010

Keywords provided by Memorial Hospital of Rhode Island:
Smoking Abstinence
Smoking Cessation