Feasibility and Acceptability of a Smoking Cessation Program for Individuals Released From an Urban, Pretrial Jail: A Pilot Randomized Clinical Trial

Tyler N A Winkelman, Becky R Ford, Shira Dunsiger, Michelle Chrastek, Sarah Cameron, Ella Strother, Beth C Bock, Andrew M Busch, Tyler N A Winkelman, Becky R Ford, Shira Dunsiger, Michelle Chrastek, Sarah Cameron, Ella Strother, Beth C Bock, Andrew M Busch

Abstract

Importance: Tobacco use prevalence among individuals involved in the criminal-legal system is 125% higher than that of the general population and leads to high levels of smoking-related morbidity and mortality.

Objective: To examine the acceptability, feasibility, and preliminary clinical outcomes of a smoking cessation intervention for individuals who are incarcerated.

Design, setting, and participants: This pilot randomized clinical trial was conducted from January 2019 to May 2020. Participants were recruited in a pretrial county jail in a large Midwestern US city and were followed up after release. Participants were incarcerated, smoked daily before incarceration, desired to stay quit or reduce cigarette smoking upon release, and expected to be released to the community within 90 days of enrollment. Data analysis was performed from June to October 2020.

Interventions: Participants randomized to the counseling plus nicotine replacement therapy (NRT) group received 1 hour of smoking cessation counseling in jail, a supply of nicotine lozenges upon release, and up to 4 telephone counseling sessions after release. Those randomized to brief health education (BHE) received 30 minutes of general health education in jail.

Main outcomes and measures: The primary clinical outcome was biologically verified 7-day point prevalence abstinence (PPA) at 3 weeks after release. Secondary clinical outcomes included 7-day PPA at 12 weeks, changes in number of cigarettes per day, and time to smoking lapse and relapse.

Results: A total of 46 participants (42 men [91%]; mean [SD] age, 38.2 [9.1] years) were enrolled and remained eligible at release; 23 were randomized to the counseling plus NRT group and 23 were randomized to the BHE group. Recruitment, enrollment, and retention of participants was feasible and acceptable. There were no significant differences in smoking abstinence between groups as determined by 7-day PPA at 3 weeks (adjusted 7-day PPA, 11.9% for counseling plus NRT vs 10.6% for BHE; odds ratio, 1.13; 95% CI, 0.14-9.07) and at 12 weeks (adjusted 7-day PPA, 11.1% for counseling plus NRT vs 14.3% for BHE; odds ratio, 0.75; 95% CI, 0.09-6.11). Cigarettes per day for the counseling plus NRT group decreased more compared with the BHE group at both 3 weeks (difference [SE], -4.58 [1.58] cigarettes per day; 95% CI, -7.67 to -1.48 cigarettes per day; P = .007) and 12 weeks (difference [SE], -3.26 [1.58] cigarettes per day; 95% CI, -5.20 to -0.20 cigarettes per day; P = .04) after release.

Conclusions and relevance: Initiation of counseling plus NRT during incarceration and continuing after release is feasible and acceptable to participants and may be associated with reduced cigarette use after release. However, additional supports are needed to increase engagement in telephone counseling after release. A larger clinical trial is warranted to determine the effectiveness of counseling plus NRT.

Trial registration: ClinicalTrials.gov Identifier: NCT03799315.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Winkelman reported receiving grants from ClearWay Minnesota, National Institute on Drug Abuse, Minnesota Department of Health, National Institute on Minority Health and Health Disparities, National Center for Advancing Translational Sciences, and Health Resources and Services Administration outside the submitted work. Dr Dunsiger reported receiving consultant payments from Hennepin Healthcare Research Institute during the conduct of the study. Dr Busch reported receiving grants from ClearWay Minnesota during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.. CONSORT Diagram of Participant Flow…
Figure 1.. CONSORT Diagram of Participant Flow Through Trial
NRT indicates nicotine replacement therapy.
Figure 2.. Cigarettes per Day Over Time
Figure 2.. Cigarettes per Day Over Time
BHE indicates brief health education; NRT, nicotine replacement therapy.

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