Working Inside for Smoking Elimination

NCT ID: NCT01122589

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoking Tobacco Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Motivation Interviewing/CBT

Group Type EXPERIMENTAL

Motivational Interviewing/CBT

Intervention Type BEHAVIORAL

6 sessions of in jail MI/CBT counseling will be administered.

Control

Receive a smoking cessation pamphlet and watch a series of six weekly 30-45 minutes general wellness videos.

Group Type ACTIVE_COMPARATOR

CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)

Intervention Type OTHER

a series of six weekly 30-45 minutes general wellness videos

Interventions

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Motivational Interviewing/CBT

6 sessions of in jail MI/CBT counseling will be administered.

Intervention Type BEHAVIORAL

CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)

a series of six weekly 30-45 minutes general wellness videos

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Memorial Hospital of Rhode Island

Principal Investigators

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Jennifer G Clarke, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Hospital of Rhode Island

Locations

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Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer G Clarke, MD

Role: CONTACT

401-729-3400

Jennifer A Mello, MPH

Role: CONTACT

401-729-3573

Facility Contacts

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Jennifer G Clarke, MD

Role: primary

401-729-3400

Jennifer A Mello, MPH

Role: backup

401-729-3573

References

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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.

Reference Type DERIVED
PMID: 26771622 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26014453 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25702731 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23567902 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21974746 (View on PubMed)

Other Identifiers

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1R01DA024093-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WISE 09-21

Identifier Type: -

Identifier Source: org_study_id