Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Bioverified 7-day point prevalence abstinence from smoking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nicotine Replacement Therapy (Drug)
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.
干预措施: Counseling (Behavioral)
结局指标
主要结局
Bioverified 7-day point prevalence abstinence from smoking
时间窗: Over 3 weeks
Bioverified 7-day point prevalence abstinence from smoking
次要结局
- Time to Lapse(1 week, 3 weeks, 12 weeks)
- Bio-verified 7-day point prevalence abstinence from smoking(Over 12 weeks)
- Depressive symptoms(1 week, 3 weeks, 12 weeks)
- Health-related quality of life(1 week, 3 weeks, 12 weeks)
- Substance abuse(1 week, 3 weeks, 12 weeks)
- Health care utilization(1 week, 3 weeks, 12 weeks)
- Time to Relapse(3 weeks, 12 weeks)
- Self-Reported Affect(1 week, 3 weeks, 12 weeks)
研究者
Tyler Winkelman
Clinician-Investigator
Hennepin Healthcare Research Institute