Working Inside for Smoking Elimination

Cigarette Smoking Clinical Trial

— WISE  

Official title:

Sustaining Tobacco Abstinence After Incarceration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01122589
• Other study ID #: WISE 09-21
• Secondary ID: 1R01DA024093-01A
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2010
• Last updated: September 8, 2010
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: September 2010
• Source: Memorial Hospital of Rhode Island
• Contact: Jennifer G Clarke, MD
• Phone: 401-729-3400
• Email: Jennifer_Clarke[@]mhri.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking
• Tobacco Smoking

Intervention

Behavioral:
• Motivational Interviewing/CBT
6 sessions of in jail MI/CBT counseling will be administered.

Other:
• CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)
a series of six weekly 30-45 minutes general wellness videos

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Hospital of Rhode Island	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence		2 years	No