Jail-Based Use of Smoking Cessation Treatment Study

NCT03799315 | Completed

• 1 other identifier: RC-2018-0013
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study's findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.

Conditions

Tobacco Use

Keywords

Incarceration; Smoking; Counseling; Nicotine Replacement; Disparities

Outcome Measures

Primary Outcomes (1)

• Bioverified 7-day point prevalence abstinence from smoking

  Bioverified 7-day point prevalence abstinence from smoking

  Over 3 weeks

Secondary Outcomes (8)

• Time to Lapse

  1 week, 3 weeks, 12 weeks

• Time to Relapse

  3 weeks, 12 weeks

• Bio-verified 7-day point prevalence abstinence from smoking

  Over 12 weeks

• Health-related quality of life

  1 week, 3 weeks, 12 weeks

• Depressive symptoms

  1 week, 3 weeks, 12 weeks

Study Arms (2)

Jail-Based Use of Smoking Cessation Treatment (JUST)

EXPERIMENTAL

Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail.

Drug: Nicotine Replacement Therapy; Behavioral: Counseling

Enhanced Treatment As Usual (TAU)

NO INTERVENTION

Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking.

Interventions

Nicotine Replacement Therapy DRUG

All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.

Jail-Based Use of Smoking Cessation Treatment (JUST)

Counseling BEHAVIORAL

All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.

Jail-Based Use of Smoking Cessation Treatment (JUST)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Use of ≥ 1 cigarette per day prior to incarceration
• Expected release from the Hennepin Adult Detention Center to the community within 90 days
• Age 18-64
• English fluency
• Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
• Willing to attempt quitting or reducing smoking at discharge
• Has a telephone
• Cleared for nicotine lozenge safety by jail health care provider and willing to use at discharge

You may not qualify if:

• Active tuberculosis
• Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
• Unable to ambulate independently
• Acute medical condition that would impair participant's ability to follow-up for assessments
• Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
• Active pregnancy
• Heart attack within the last two weeks

Sponsors & Collaborators

• Hennepin Healthcare Research Institute: lead
• Hennepin County Adult Detention Center: collaborator
• Brown University: collaborator

Study Sites (1)

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (24)

• Jamal A, King BA, Neff LJ, Whitmill J, Babb SD, Graffunder CM. Current Cigarette Smoking Among Adults - United States, 2005-2015. MMWR Morb Mortal Wkly Rep. 2016 Nov 11;65(44):1205-1211. doi: 10.15585/mmwr.mm6544a2.

  PMID: 27832052 BACKGROUND

• Winkelman TNA, Vickery KD, Busch AM. Tobacco use among non-elderly adults with and without criminal justice involvement in the past year: United States, 2008-2016. Addict Sci Clin Pract. 2019 Jan 11;14(1):2. doi: 10.1186/s13722-019-0131-y.

  PMID: 30635028 BACKGROUND

• Puljevic C, Kinner SA, de Andrade D. Extending smoking abstinence after release from smoke-free prisons: protocol for a randomised controlled trial. Health Justice. 2017 Dec;5(1):1. doi: 10.1186/s40352-016-0046-6. Epub 2017 Jan 23.

  PMID: 28116579 BACKGROUND

• Binswanger IA, Carson EA, Krueger PM, Mueller SR, Steiner JF, Sabol WJ. Prison tobacco control policies and deaths from smoking in United States prisons: population based retrospective analysis. BMJ. 2014 Aug 5;349:g4542. doi: 10.1136/bmj.g4542.

  PMID: 25097186 BACKGROUND

• Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613.

  BACKGROUND

• Winkelman TN, Kieffer EC, Goold SD, Morenoff JD, Cross K, Ayanian JZ. Health Insurance Trends and Access to Behavioral Healthcare Among Justice-Involved Individuals-United States, 2008-2014. J Gen Intern Med. 2016 Dec;31(12):1523-1529. doi: 10.1007/s11606-016-3845-5.

  PMID: 27638837 BACKGROUND

• Winkelman TN, Choi H, Davis MM. The Affordable Care Act, Insurance Coverage, and Health Care Utilization of Previously Incarcerated Young Men: 2008-2015. Am J Public Health. 2017 May;107(5):807-811. doi: 10.2105/AJPH.2017.303703. Epub 2017 Mar 21.

  PMID: 28323472 BACKGROUND

• Vickery KD, Bodurtha P, Winkelman TNA, Hougham C, Owen R, Legler MS, Erickson E, Davis MM. Cross-Sector Service Use Among High Health Care Utilizers In Minnesota After Medicaid Expansion. Health Aff (Millwood). 2018 Jan;37(1):62-69. doi: 10.1377/hlthaff.2017.0991.

  PMID: 29309230 BACKGROUND

• Frank JW, Linder JA, Becker WC, Fiellin DA, Wang EA. Increased hospital and emergency department utilization by individuals with recent criminal justice involvement: results of a national survey. J Gen Intern Med. 2014 Sep;29(9):1226-33. doi: 10.1007/s11606-014-2877-y. Epub 2014 May 10.

  PMID: 24817280 BACKGROUND

• 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: 21974746 BACKGROUND

• 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: 23567902 BACKGROUND

• Mulder I, Tijhuis M, Smit HA, Kromhout D. Smoking cessation and quality of life: the effect of amount of smoking and time since quitting. Prev Med. 2001 Dec;33(6):653-60. doi: 10.1006/pmed.2001.0941.

  PMID: 11716663 BACKGROUND

• Piper ME, Kenford S, Fiore MC, Baker TB. Smoking cessation and quality of life: changes in life satisfaction over 3 years following a quit attempt. Ann Behav Med. 2012 Apr;43(2):262-70. doi: 10.1007/s12160-011-9329-2.

  PMID: 22160762 BACKGROUND

• Lemon SC, Friedmann PD, Stein MD. The impact of smoking cessation on drug abuse treatment outcome. Addict Behav. 2003 Sep;28(7):1323-31. doi: 10.1016/s0306-4603(02)00259-9.

  PMID: 12915172 BACKGROUND

• Thurgood SL, McNeill A, Clark-Carter D, Brose LS. A Systematic Review of Smoking Cessation Interventions for Adults in Substance Abuse Treatment or Recovery. Nicotine Tob Res. 2016 May;18(5):993-1001. doi: 10.1093/ntr/ntv127. Epub 2015 Jun 11.

  PMID: 26069036 BACKGROUND

• Busch AM, Tooley EM, Dunsiger S, Chattillion EA, Srour JF, Pagoto SL, Kahler CW, Borrelli B. Behavioral activation for smoking cessation and mood management following a cardiac event: results of a pilot randomized controlled trial. BMC Public Health. 2017 Apr 17;17(1):323. doi: 10.1186/s12889-017-4250-7.

  PMID: 28415979 BACKGROUND

• A randomised controlled study of the Health Intervention "SNAP" in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking. Trial Review. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371923. Published October 10, 2017. Accessed December 29, 2017.

  BACKGROUND

• de Andrade D, Kinner SA. Systematic review of health and behavioural outcomes of smoking cessation interventions in prisons. Tob Control. 2016 Sep;26(5):495-501. doi: 10.1136/tobaccocontrol-2016-053297. Epub 2016 Oct 18.

  PMID: 27798322 BACKGROUND

• Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008. https://bphc.hrsa.gov/buckets/treatingtobacco.pdf. Accessed October 17, 2017.

  BACKGROUND

• Prisoner Research FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/ guidance/faq/prisoner-research/index.html. Accessed December 18, 2017.

  BACKGROUND

• Binswanger IA, Nowels C, Corsi KF, Long J, Booth RE, Kutner J, Steiner JF. "From the prison door right to the sidewalk, everything went downhill," a qualitative study of the health experiences of recently released inmates. Int J Law Psychiatry. 2011 Jul-Aug;34(4):249-55. doi: 10.1016/j.ijlp.2011.07.002. Epub 2011 Jul 29.

  PMID: 21802731 BACKGROUND

• Wang EA, White MC, Jamison R, Goldenson J, Estes M, Tulsky JP. Discharge planning and continuity of health care: findings from the San Francisco County Jail. Am J Public Health. 2008 Dec;98(12):2182-4. doi: 10.2105/AJPH.2007.119669. Epub 2008 Apr 1.

  PMID: 18381994 BACKGROUND

• Wang EA, Green J. Incarceration as a key variable in racial disparities of asthma prevalence. BMC Public Health. 2010 May 28;10:290. doi: 10.1186/1471-2458-10-290.

  PMID: 20509891 BACKGROUND

• Winkelman TNA, Ford BR, Dunsiger S, Chrastek M, Cameron S, Strother E, Bock BC, Busch AM. Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2115687. doi: 10.1001/jamanetworkopen.2021.15687.

  PMID: 34228127 DERIVED

MeSH Terms

Conditions

Tobacco Use; Smoking

Interventions

Nicotine Replacement Therapy; Counseling

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Investigator

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 10, 2019
• Study Start: January 14, 2019
• Primary Completion: March 16, 2020
• Study Completion: August 29, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

US (1)