Clinical trial NCT03799315: Jail-Based Use of Smoking Cessation Treatment Study
Official title: Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Keywords: Incarceration
Smoking
Counseling
Nicotine Replacement
Disparities
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Hennepin County Adult Detention Center
name: Brown University
First posted: 2019-01-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bioverified 7-day point prevalence abstinence from smoking
timeFrame: Over 3 weeks
Secondary outcomes:
measure: Time to Lapse
timeFrame: 1 week, 3 weeks, 12 weeks
measure: Time to Relapse
timeFrame: 3 weeks, 12 weeks
measure: Bio-verified 7-day point prevalence abstinence from smoking
timeFrame: Over 12 weeks
measure: Health-related quality of life
timeFrame: 1 week, 3 weeks, 12 weeks
measure: Depressive symptoms
timeFrame: 1 week, 3 weeks, 12 weeks
measure: Self-Reported Affect
timeFrame: 1 week, 3 weeks, 12 weeks
measure: Health care utilization
timeFrame: 1 week, 3 weeks, 12 weeks
measure: Substance abuse
timeFrame: 1 week, 3 weeks, 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
Study officials:
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