Cigarette SmokingWISENCT01122589
Working Inside for Smoking Elimination
A study testing Motivational Interviewing/CBT in people with Cigarette Smoking and Tobacco Smoking, run by Memorial Hospital of Rhode Island at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Tobacco Smoking
- What is being tested?
- Motivational Interviewing/CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
Jennifer G Clarke, MD, 401-729-3400, Jennifer_Clarke@mhri.org
Jennifer A Mello, MPH, 401-729-3573, Jennifer_Mello@mhri.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigarette Smoking, Tobacco Smoking
- Being tested
- Motivational Interviewing/CBT, CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)
- Keywords
- Smoking Abstinence, Smoking Cessation
- Medical subject headings
- Cigarette Smoking, Tobacco Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing/CBTBehavioural
6 sessions of in jail MI/CBT counseling will be administered.
CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)Other
a series of six weekly 30-45 minutes general wellness videos
| Study group | Role | What they receive |
|---|---|---|
| Motivation Interviewing/CBT | Experimental | Not described Receives: 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. Receives: Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Jennifer G Clarke, MD, Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122589
- Sponsor's protocol ID
- WISE 09-21
- Other IDs
- 1R01DA024093-01A2
- Acronym
- WISE
- Status last verified
- Sep 2010
- First submitted
- 12 May 2010
- Last updated
- 9 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26771622Parker 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.
PubMed 26014453Clarke 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.
PubMed 25702731Clarke 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.
PubMed 23567902Clarke 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.
PubMed 21974746
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Tobacco Abstinence After Incarceration
- ClinicalTrials.gov ID
- NCT01122589
- Acronym / sponsor ID
- WISE / WISE 09-21
- Conditions
- Cigarette Smoking, Tobacco Smoking
- Keywords
- Smoking Abstinence, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivation Interviewing/CBT | Experimental | Behavioral: Motivational Interviewing/CBT |
| Control | Active comparator | Other: CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)Receive a smoking cessation pamphlet and watch a series of six weekly 30-45 minutes general wellness videos. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing/CBT6 sessions of in jail MI/CBT counseling will be administered. | Behavioural | Motivation Interviewing/CBT |
| CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)a series of six weekly 30-45 minutes general wellness videos | Other | Control |
Primary outcome
Smoking abstinence
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.
- Derived from this study: PubMed 26771622van 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.
- Derived from this study: PubMed 26014453Parker 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.
- Derived from this study: PubMed 25702731Clarke 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.
- Derived from this study: PubMed 23567902Clarke 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.
- Derived from this study: PubMed 21974746Clarke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer G Clarke, MD principal investigator
Memorial Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing/CBT in people with Cigarette Smoking and Tobacco Smoking, run by Memorial Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer G Clarke, MD (401-729-3400, Jennifer_Clarke@mhri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01122589, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010; AzTrials last refreshed its copy on 27 Oct 2026.