Jail-Based Use of Smoking Cessation Treatment Study (JUST)

Hennepin Healthcare

Status: Completed

Conditions: Tobacco Use

Treatments: Drug: Nicotine Replacement Therapy; Behavioral: Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03799315

RC-2018-0013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Jail-Based Use of Smoking Cessation Treatment (JUST)

Experimental group

Description:

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.

Treatment:

Drug: Nicotine Replacement Therapy

Behavioral: Counseling

Enhanced Treatment As Usual (TAU)

No Intervention group

Description:

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.