NCT03799315

Jail-Based Use of Smoking Cessation Treatment Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hennepin Healthcare Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
DRUG	Nicotine Replacement Therapy	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.
BEHAVIORAL	Counseling	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.

Timeline

• Start date: 2019-01-14
• Primary completion: 2020-03-16
• Completion: 2020-08-29
• First posted: 2019-01-10
• Last updated: 2020-09-14

Locations

1 site across 1 country: United States