An interventional study of Nicotine Replacement Therapy and Counseling in Tobacco Use, sponsored by Hennepin Healthcare Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-14.
Sponsored by Hennepin Healthcare Research Institute · Not applicable, Interventional, and Treatment
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.
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.
Hennepin Healthcare Research Institute is the lead sponsor of 69 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: Counseling
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.
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.
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.
Bioverified 7-day point prevalence abstinence from smoking
Bioverified 7-day point prevalence abstinence from smoking
Time frame: Over 3 weeks
Time to Lapse
Days to first lapse (i.e., any cigarette use, even a puff)
Time frame: 1 week, 3 weeks, 12 weeks
Time to Relapse
Days to first relapse
Time frame: 3 weeks, 12 weeks
Bio-verified 7-day point prevalence abstinence from smoking
Bioverified 7-day point prevalence abstinence from smoking
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week, 3 weeks, 12 weeks
Health care utilization
Self-reported hospitalizations and use of the emergency department
Time frame: 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.
Time frame: 1 week, 3 weeks, 12 weeks
Plan to share: Undecided
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Hennepin Healthcare Research Institute