Clincosm LogoSign in Get a demo

WISE: Working Inside for Smoking Elimination

Sponsor
Memorial Hospital of Rhode Island (Other)
Overall Status
Unknown status
CT.gov ID
NCT01122589
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
350
Enrollment
1
Location
2
Arms
17.9
Duration (Months)
19.5
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Behavioral: Motivational Interviewing/CBT
  • Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)
 N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2010
Anticipated Primary Completion Date :
Apr 1, 2011
Anticipated Study Completion Date :
Aug 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Smoking abstinence [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Memorial Hospital of Rhode Island Pawtucket Rhode Island United States 02860

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01122589
Other Study ID Numbers:
  • WISE 09-21
  • 1R01DA024093-01A2
First Posted:
May 13, 2010
Last Update Posted:
Sep 9, 2010
Last Verified:
Sep 1, 2010
Keywords provided by , ,
Smoking Abstinence
Smoking Cessation

Study Results

No Results Posted as of Sep 9, 2010