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Working Inside for Smoking Elimination (WISE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Memorial Hospital of Rhode Island.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01122589
First Posted: May 13, 2010
Last Update Posted: September 9, 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 Institute on Drug Abuse (NIDA)
Information provided by:
Memorial Hospital of Rhode Island
  Purpose
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 Intervention
Cigarette Smoking Tobacco Smoking Behavioral: Motivational Interviewing/CBT Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sustaining Tobacco Abstinence After Incarceration

Resource links provided by NLM:


Further study details as provided by Memorial Hospital of Rhode Island:

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

Estimated Enrollment: 350
Study Start Date: February 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
  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): 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
  More Information

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 Submitted: May 12, 2010
First Posted: May 13, 2010
Last Update Posted: September 9, 2010
Last Verified: September 2010

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