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Completed

NCT Number: NCT03799315

Jail-Based Use of Smoking Cessation Treatment Study

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.

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Key information

Conditions

Tobacco Use Behavior Smoking

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, 55415, United States

About this study

Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Bioverified 7-day point prevalence abstinence from smoking

    Time frame: Over 3 weeks

    Bioverified 7-day point prevalence abstinence from smoking

Secondary outcomes

  1. Time to Lapse

    Time frame: 1 week, 3 weeks, 12 weeks

    Days to first lapse (i.e., any cigarette use, even a puff)

  2. Time to Relapse

    Time frame: 3 weeks, 12 weeks

    Days to first relapse

  3. Bio-verified 7-day point prevalence abstinence from smoking

    Time frame: Over 12 weeks

    Bioverified 7-day point prevalence abstinence from smoking

  4. Health-related quality of life

    Time frame: 1 week, 3 weeks, 12 weeks

    Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health.

  5. Depressive symptoms

    Time frame: 1 week, 3 weeks, 12 weeks

    The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms.

  6. Self-Reported Affect

    Time frame: 1 week, 3 weeks, 12 weeks

    10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.

  7. Health care utilization

    Time frame: 1 week, 3 weeks, 12 weeks

    Self-reported hospitalizations and use of the emergency department

  8. Substance abuse

    Time frame: 1 week, 3 weeks, 12 weeks

    Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.

Sponsors and collaborators

Lead sponsor

Hennepin Healthcare Research Institute

Other

Collaborators

  • Brown University
  • Hennepin County Adult Detention Center

Registry information

Official study title

Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County

Acronym: JUST

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2019
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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