Abstinence Reinforcement Therapy for Veterans Who Smoke Tobacco and Are Experiencing Homelessness (New HART)
2026年7月15日 更新者：VA Office of Research and Development
Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans.
Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people.
The purpose of this study study is to evaluate the effectiveness of an intervention to help Veterans experiencing homelessness stop smoking.
The intervention, called Abstinence Reinforcement Therapy + (ART+), includes telehealth-based counseling, smoking cessation aids, and mobile contingency management (mCM).
mCM is an intervention in which participants are paid for smoking abstinence.
120 Veterans who smoke cigarettes and are experiencing homelessness will be randomly assigned to receive either ART+ or usual smoking cessation care.
The primary outcome to be evaluated is the rate at which Veterans assigned to the ART+ condition report smoking abstinence and have their abstinence verified using salivary testing.
研究概览
地位
尚未招聘
条件
详细说明
Significance to VA: Seventy to eighty percent of Veterans experiencing homelessness (VEH) smoke, which is four times the rate of the U.S. population and 2.5 times higher than among impoverished Americans.
Smoking- related deaths among persons experiencing homelessness occur at double the rate seen among more stably housed people.
While there are numerous challenges to smoking cessation among Veterans experiencing homelessness, four in five homeless smokers report interest in quitting.
Innovation and Impact: The investigators recently developed and evaluated the effectiveness of a multi-component intervention called Abstinence Reinforcement Therapy (ART), which combined five sessions of telehealth-based cognitive-behavioral therapy, provision of smoking cessation aids, and four weeks of mobile contingency management (mCM).
The investigators have added an additional CM period of eight weeks and opportunities for booster calls and repeated quit attempts, resulting in an intervention called ART+ to improve outcomes over time.
The innovative use of web-based platform technology in the current proposal will remove numerous barriers that often prevent smokers experiencing homelessness from accessing high-quality, evidence-based care.
There is tremendous inequity in smoking-related outcomes for VEH.
The innovative use of mobile health technology in the current proposal will remove numerous barriers that often prevent Veterans who smoke and experience homelessness from accessing high- quality, evidence-based care.
Specific Aims: Aim 1: Evaluate the comparative effectiveness of ART+ on bio-verified abstinence outcomes at three-, six-and 12-month follow-ups.
The primary endpoint will be bioverified prolonged abstinence at the six-month follow-up.
Aim 2: Assess the relative cost-effectiveness of ART+ to VA standard care smoking cessation on quality adjusted life years (QALY).
Aim 3: Qualitatively evaluate implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs.
Methodology: 120 Veterans experiencing homelessness who smoke cigarettes will be randomly assigned to ART+ or to VA standard smoking cessation care.
Self-reported and bioverified abstinence at six months are the primary outcomes.
Cost-effectiveness analyses will be performed using QALY as the effectiveness measure.
Rapid qualitative analytic methods will be used to evaluate implementation determinants of ART+ following enrollment of all study participants.
Participants for the qualitative analysis will include clinicians and clinical support staff who provide care to Veterans experiencing homelessness, designated VA operations partners, and VA Tobacco Treatment Specialists.
Purposive sampling will be used to identify potential participants and a structured interview guide based upon domains from the Consolidated Framework for Implementation Research (CFIR) will be administered.
The investigators will use rapid qualitative analysis to answer the key qualitative research question: "What determinants will impact implementation of ART+?"
The benefit of decreasing tobacco use (Aim 1) among VEH who smoke is tremendous as it will prevent significant morbidity and mortality.
Moreover, if ART+ is shown to be cost effective (Aim 2) and implementation determinants are identified (Aim 3), the use of mobile phones as a platform to provide behavioral incentives has the potential to transform the delivery of smoking cessation care.
Path to Translation/Implementation: Cost-effectiveness analysis (Aim 2) will help guide implementation decisions.
Qualitative evaluation of the implementation determinants of ART+ within Specialty Smoking Clinics and VA primary care for VEH programs (Aim 3) will provide important information on effective implementation of ART+.
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Angela C Kirby, MS
- 电话号码：7456 (919) 286-0411
- 邮箱：angela.kirby@va.gov
学习地点
-
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North Carolina
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Durham、North Carolina、美国、27705-3875
- Durham VA Medical Center, Durham, NC
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接触：
- Angela C Kirby, MS
- 电话号码：7456 919-286-0411
- 邮箱：angela.kirby@va.gov
-
首席研究员：
- Jean C Beckham, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Are homeless
- Smoke at least 5 cigarettes daily with CO indicating current smoking at time of screening assessment
- Are willing to try to quit smoking in next 30 days
Exclusion Criteria:
- Have uncontrolled psychotic symptoms
- Have active substance dependence other than nicotine (participants in partial remission with at least one month sobriety will be included)
- Have severely impaired hearing or speech
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Abstinence Reinforcement Therapy +
Abstinence Reinforcement Therapy +, or ART+, includes five sessions and several booster sessions of cognitive-behavioral therapy for smoking cessation, two forms of nicotine replacement therapy plus bupropion or varenicline, and mobile contingency management for smoking cessation.
|
Five core sessions of CBT plus up to four monthly booster sessions designed to help Veterans prepare to quit smoking, make a quit attempt, and prevent relapse to smoking.
其他名称：
NRT is a group of over-the-counter medications designed to help users quit smoking.
Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).
其他名称：
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
其他名称：
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
其他名称：
Smoking abstinence will be intermittently reinforced.
For each carbon monoxide (CO) reading that a participant provides that suggest smoking abstinence, the participant will earn spins on a virtual prize wheel that has financial prizes.
其他名称：
|
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有源比较器：Standard Care Condition
Standard Care Condition will involve referral to local VA clinic-based smoking cessation care.
This care often includes pharmacotherapy, counseling options, and/or use of a telephone-based, texting-based or app-based smoking cessation program.
|
NRT is a group of over-the-counter medications designed to help users quit smoking.
Standard of care often involves use of nicotine patch plus one rescue method (either gum or lozenge).
其他名称：
Bupropion is an FDA-approved prescription smoking cessation aid.
Participants will be prescribed 150-300 mg.
其他名称：
Varenicline is an FDA-approved prescription smoking cessation aid.
Participants will be 0.5 to 2 mg.
其他名称：
Participants assigned to the usual care condition may participate in group counseling for smoking cessation, which can also include use of phone-based smoking cessation resources such as a telephone quit line, a texting program, and a smoking cessation app.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants whose self-report of prolonged smoking abstinence is bioverified
大体时间：6-month follow-up, about six months after baseline
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Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)
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6-month follow-up, about six months after baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants whose self-report of prolonged smoking abstinence is bioverified
大体时间：3-month follow-up, about three months after baseline
|
Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL)
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3-month follow-up, about three months after baseline
|
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Number of participants whose self-report of prolonged smoking abstinence is bioverified
大体时间：12-month follow-up, about twelve months after baseline
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Prolonged abstinence is defined as 30 days abstinent.
For participants who are not using NRT/vapes/e-cigarettes at follow-up, abstinence will be based upon: 1) self-reported abstinence; 2) no biochemical samples indicating smoking (CO ≥ 5 ppm or cotinine ≥ 6 ng/mL); and 3) at least one sample indicating abstinence (CO < 5 ppm and/or cotinine < 6 ng/mL
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12-month follow-up, about twelve months after baseline
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Number of participants who self-report 7-day point prevalence abstinence
大体时间：3-month follow-up, about three months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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3-month follow-up, about three months after baseline
|
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Number of participants who self-report 7-day point prevalence abstinence
大体时间：6-month follow-up, about six months after baseline
|
7-day point prevalence abstinence is defined as no smoking in the prior 7 days
|
6-month follow-up, about six months after baseline
|
|
Number of participants who self-report 7-day point prevalence abstinence
大体时间：12-month follow-up, about twelve months after baseline
|
7-day point prevalence abstinence is defined as no smoking in the prior 7 days
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12-month follow-up, about twelve months after baseline
|
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Number of participants who self-report 30-day point prevalence abstinence
大体时间：3-month follow-up, about three months after baseline
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7-day point prevalence abstinence is defined as no smoking in the prior 30 days
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3-month follow-up, about three months after baseline
|
|
Number of participants who self-report 30-day point prevalence abstinence
大体时间：6-month follow-up, about six months after baseline
|
7-day point prevalence abstinence is defined as no smoking in the prior 30 days
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6-month follow-up, about six months after baseline
|
|
Number of participants who self-report 30-day point prevalence abstinence
大体时间：12-month follow-up, about twelve months after baseline
|
30-day point prevalence abstinence is defined as no smoking in the prior 30 days
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12-month follow-up, about twelve months after baseline
|
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Number of participants who self-report early continuous abstinence
大体时间：3-month follow-up, about three months after baseline
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Early continuous abstinence will be defined as reporting two weeks of continuous abstinence during the first four weeks after the quit day
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3-month follow-up, about three months after baseline
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Incremental Cost-Effectiveness Ratio
大体时间：12 months post quit, about 12 months after baseline
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Measure of cost-effectiveness; costs as the numerator and effectiveness as measured by quality-adjusted life years (QALY) as the denominator.
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12 months post quit, about 12 months after baseline
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Percentage of carbon monoxide reading completion by participants in ART+ intervention group
大体时间：3-month follow-up, about three months after baseline
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Patient intervention utilization will be measured by the percentage of prompted carbon monoxide readings that participants in the ART+ condition complete during the treatment period.
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3-month follow-up, about three months after baseline
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Number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in ART+ intervention group
大体时间：3-month follow-up, about three months after baseline
|
Patient intervention utilization will be measured by the number of behavioral cognitive-behavioral therapy (CBT) sessions completed by participants in the ART+ condition during the treatment period
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3-month follow-up, about three months after baseline
|
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Number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period
大体时间：3-month follow-up, about three months after baseline
|
Patient intervention utilization will be measured by the number of participants in ART+ intervention group who withdraw or are lost to contact during the treatment period.
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3-month follow-up, about three months after baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jean C Beckham, PhD、Durham VA Medical Center, Durham, NC
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年3月1日
初级完成 (估计的)
2030年3月1日
研究完成 (估计的)
2030年9月1日
研究注册日期
首次提交
2026年7月15日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月20日
研究记录更新
最后更新发布 (实际的)
2026年7月20日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- HSR2-003-25M
- 1924743 (其他标识符：Durham VA Medical Center IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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