Working Inside for Smoking Elimination (WISE)

Sustaining Tobacco Abstinence After Incarceration

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.

Study Overview

• Status: Unknown
• Conditions: Tobacco Smoking; Cigarette Smoking
• Intervention / Treatment: 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
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Recruiting
      • Memorial Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking abstinence	2 years

Collaborators and Investigators

• Sponsor: Memorial Hospital of Rhode Island
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jennifer G Clarke, MD, Memorial Hospital of Rhode Island

Publications and helpful links

General Publications

• van den Berg JJ, Roberts MB, Bock BC, Martin RA, Stein LA, Parker DR, McGovern AR, Shuford SH, Clarke JG. Changes in Depression and Stress after Release from a Tobacco-Free Prison in the United States. Int J Environ Res Public Health. 2016 Jan 12;13(1):114. doi: 10.3390/ijerph13010114.
• Parker DR, Roberts MB, van den Berg JJ, Bock B, Stein LA, Martin RA, Clarke JG. Exploration of Incarcerated Men's and Women's Attitudes of Smoking in the Presence of Children and Pregnant Women: Is There a Disparity Between Smoking Attitudes and Smoking Behavior? Nicotine Tob Res. 2016 May;18(5):919-25. doi: 10.1093/ntr/ntv112. Epub 2015 May 25.
• Clarke JG, Martin SA, Martin RA, Stein LA, van den Berg JJ, Parker DR, McGovern AR, Roberts MB, Bock BC. Changes in smoking-related symptoms during enforced abstinence of incarceration. J Health Care Poor Underserved. 2015 Feb;26(1):106-18. doi: 10.1353/hpu.2015.0014.
• Clarke JG, Stein LA, Martin RA, Martin SA, Parker D, Lopes CE, McGovern AR, Simon R, Roberts M, Friedman P, Bock B. Forced smoking abstinence: not enough for smoking cessation. JAMA Intern Med. 2013 May 13;173(9):789-94. doi: 10.1001/jamainternmed.2013.197.
• Clarke JG, Martin RA, Stein L, Lopes CE, Mello J, Friedmann P, Bock B. Working Inside for Smoking Elimination (Project W.I.S.E.) study design and rationale to prevent return to smoking after release from a smoke free prison. BMC Public Health. 2011 Oct 5;11:767. doi: 10.1186/1471-2458-11-767.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Anticipated): April 1, 2011
• Study Completion (Anticipated): August 1, 2011

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: May 12, 2010
• First Posted (Estimate): May 13, 2010

Study Record Updates

• Last Update Posted (Estimate): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 8, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Smoking Cessation; Smoking Abstinence
• Other Study ID Numbers: WISE 09-21; 1R01DA024093-01A2 (U.S. NIH Grant/Contract)