Jail-Based Use of Smoking Cessation Treatment Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tobacco Use

Intervention / Treatment
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* Drug: Nicotine Replacement Therapy
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jail-Based Use of Smoking Cessation Treatment (JUST)<br>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<br>* 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.<br>Behavioral: Counseling<br>* 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.<br>|
| No Intervention: Enhanced Treatment As Usual (TAU)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioverified 7-day point prevalence abstinence from smoking | Bioverified 7-day point prevalence abstinence from smoking | Over 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Lapse | Days to first lapse (i.e., any cigarette use, even a puff) | 1 week, 3 weeks, 12 weeks | 
| Time to Relapse | Days to first relapse | 3 weeks, 12 weeks | 
| Bio-verified 7-day point prevalence abstinence from smoking | Bioverified 7-day point prevalence abstinence from smoking | Over 12 weeks | 
| Health-related quality of life | Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health. | 1 week, 3 weeks, 12 weeks | 
| Depressive symptoms | The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms. | 1 week, 3 weeks, 12 weeks | 
| Self-Reported Affect | 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. | 1 week, 3 weeks, 12 weeks | 
| Health care utilization | Self-reported hospitalizations and use of the emergency department | 1 week, 3 weeks, 12 weeks | 
| Substance abuse | Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse. | 1 week, 3 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incarceration, Smoking, Counseling, Nicotine Replacement, Disparities