Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of participants who attended coaching sessions
研究概览
简要总结
This study is investigating tobacco use and providing tobacco treatment among people experiencing homelessness in California, in San Francisco and Los Angeles.
详细描述
PRIMARY OBJECTIVES:
I. Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up.
II. Use expired carbon monoxide (CO) to confirm self-reports of abstinence using a cut-off of CO ≤5 parts per million (ppm).
SECONDARY OBJECTIVES:
I. Biochemically-verified 7-day point prevalence tobacco abstinence at 3-months follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Able to understand study procedures and to comply with them for the entire length of the study.
- •Ability of individual to understand a written informed consent document, and the willingness to sign it.
- •Staying at the recruitment site and meeting criteria for homelessness as defined by the Homeless Emergency and Rapid Transition to Housing Act.
- •Current smoking (smoking at least 5 cigarettes per day (cpd), verified via expired carbon monoxide (CO) >= 8 ppm using Micro+pro Smokerlyzer).
- •Having an intention to quit smoking within the next six months.
- •English speaking.
排除标准
- •Contraindication to any study-related procedure or assessment.
- •Reasons that preclude the use of nicotine replacement therapy (NRT) (e.g., pregnancy or myocardial infarction in the past two weeks).
研究组 & 干预措施
Treatment (extended intervention for tobacco use)
Participants receive pharmacist provided one-time tobacco treatment using the five As: Ask, Advise, Assess, Assist and Arrange (5As) model and receives an initial monthly delivery of nicotine replacement therapy (NRT) for 3 months. Participants then receive the extended intervention for tobacco use (EXIT) that consists of: 1) health coach-delivered, weekly-to-monthly wellness-focused telephone coaching for 6 months addressing tobacco use within the context of co-occurring psychiatric and substance-use comorbidities and other life stressors, and 2) an additional session of pharmacist-delivered 5As with monthly delivery of NRT for an additional 6 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
Treatment (extended intervention for tobacco use)
Participants receive pharmacist provided one-time tobacco treatment using the five As: Ask, Advise, Assess, Assist and Arrange (5As) model and receives an initial monthly delivery of nicotine replacement therapy (NRT) for 3 months. Participants then receive the extended intervention for tobacco use (EXIT) that consists of: 1) health coach-delivered, weekly-to-monthly wellness-focused telephone coaching for 6 months addressing tobacco use within the context of co-occurring psychiatric and substance-use comorbidities and other life stressors, and 2) an additional session of pharmacist-delivered 5As with monthly delivery of NRT for an additional 6 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.
干预措施: Wellness Coaching (Behavioral)
Pharm-only
Participants receive pharmacist provided one-time tobacco treatment using the 5As and receive monthly delivery of NRT for 3 months. Participants will provide CO samples for biochemical verification of smoking abstinence and complete questionnaires throughout the study.
干预措施: Nicotine Replacement Therapy (NRT) (Drug)
结局指标
主要结局
Percentage of participants who attended coaching sessions
时间窗: up to 6 months
The percentage of participants who attended at least 75% or 7 of the 14 coaching sessions will be reported.
Percentage of participants who used nicotine replacement therapy (NRT)
时间窗: up to 6 months
The percentage of participants who used at least 75% will adhere to using NRT for at least half of the treatment duration will be reported.
7-day point prevalence tobacco abstinence at month 6
时间窗: 6 months
Biochemically verified 7-day point prevalence tobacco abstinence at 6-months follow-up will be reported.
次要结局
- 7-day point prevalence tobacco abstinence at month 3(3 months)