Jail-Based Use of Smoking Cessation Treatment Study
- Conditions
- Tobacco Use
- Interventions
- Behavioral: Counseling
- Registration Number
- NCT03799315
- Lead Sponsor
- Hennepin Healthcare Research Institute
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Jail-Based Use of Smoking Cessation Treatment (JUST) Nicotine Replacement Therapy 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. Jail-Based Use of Smoking Cessation Treatment (JUST) Counseling 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.
- Primary Outcome Measures
Name Time Method Bioverified 7-day point prevalence abstinence from smoking Over 3 weeks Bioverified 7-day point prevalence abstinence from smoking
- Secondary Outcome Measures
Name Time Method Time to Lapse 1 week, 3 weeks, 12 weeks Days to first lapse (i.e., any cigarette use, even a puff)
Bio-verified 7-day point prevalence abstinence from smoking Over 12 weeks Bioverified 7-day point prevalence abstinence from smoking
Health-related quality of life 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.
Depressive symptoms 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.
Substance abuse 1 week, 3 weeks, 12 weeks Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.
Health care utilization 1 week, 3 weeks, 12 weeks Self-reported hospitalizations and use of the emergency department
Time to Relapse 3 weeks, 12 weeks Days to first relapse
Self-Reported Affect 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.
Trial Locations
- Locations (1)
Hennepin Healthcare Research Institute
🇺🇸Minneapolis, Minnesota, United States