NCT01122589

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 9, 2010

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

May 12, 2010

Last Update Submit

September 8, 2010

Conditions

Cigarette SmokingTobacco Smoking

Keywords

Smoking AbstinenceSmoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Smoking abstinence

    2 years

Study Arms (2)

Motivation Interviewing/CBT

EXPERIMENTAL
Behavioral: Motivational Interviewing/CBT

Control

ACTIVE COMPARATOR

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)

Interventions

Motivational Interviewing/CBTBEHAVIORAL

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

Motivation Interviewing/CBT
CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)OTHER

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26771622DERIVED

  • 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.

    PMID: 26014453DERIVED

  • 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.

    PMID: 25702731DERIVED

  • 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.

    PMID: 23567902DERIVED

  • 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.

    PMID: 21974746DERIVED

MeSH Terms

Conditions

Cigarette SmokingTobacco SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco UseHealth Behavior

Study Officials

  • Jennifer G Clarke, MD

    Memorial Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer G Clarke, MD

CONTACT

401-729-3400Jennifer_Clarke@mhri.org

Jennifer A Mello, MPH

CONTACT

401-729-3573Jennifer_Mello@mhri.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2010

First Posted

May 13, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2011

Study Completion

August 1, 2011

Last Updated

September 9, 2010

Record last verified: 2010-09

Locations

US(1)