Jail-Based Use of Smoking Cessation Treatment Study (JUST)
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|ClinicalTrials.gov Identifier: NCT03799315|
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use||Drug: Nicotine Replacement Therapy Behavioral: Counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County|
|Actual Study Start Date :||January 14, 2019|
|Actual Primary Completion Date :||March 16, 2020|
|Actual Study Completion Date :||August 29, 2020|
Experimental: Jail-Based Use of Smoking Cessation Treatment (JUST)
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
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.
No Intervention: Enhanced Treatment As Usual (TAU)
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.
- Bioverified 7-day point prevalence abstinence from smoking [ Time Frame: Over 3 weeks ]Bioverified 7-day point prevalence abstinence from smoking
- Time to Lapse [ Time Frame: 1 week, 3 weeks, 12 weeks ]Days to first lapse (i.e., any cigarette use, even a puff)
- Time to Relapse [ Time Frame: 3 weeks, 12 weeks ]Days to first relapse
- Bio-verified 7-day point prevalence abstinence from smoking [ Time Frame: Over 12 weeks ]Bioverified 7-day point prevalence abstinence from smoking
- Health-related quality of life [ Time Frame: 1 week, 3 weeks, 12 weeks ]Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health.
- Depressive symptoms [ Time Frame: 1 week, 3 weeks, 12 weeks ]The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms.
- Self-Reported Affect [ Time Frame: 1 week, 3 weeks, 12 weeks ]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.
- Health care utilization [ Time Frame: 1 week, 3 weeks, 12 weeks ]Self-reported hospitalizations and use of the emergency department
- Substance abuse [ Time Frame: 1 week, 3 weeks, 12 weeks ]Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799315
|United States, Minnesota|
|Hennepin Healthcare Research Institute|
|Minneapolis, Minnesota, United States, 55415|