Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
研究概览
地位
详细说明
Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Veterans who are homeless, along with those who have mental health or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at tremendous risk for smoking related morbidity and mortality. This information suggests that smoking needs to be targeted specifically among this high risk population of smokers.
The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is a behavioral therapy that provides positive reinforcers to individuals misusing substances contingent upon objective evidence of abstinence from substance use. Because CM requires verification of abstinence multiple times daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to inpatient and day treatment programs. The application of emerging smart phone technology, however, can overcome this barrier, and may be particularly well suited to homeless Veterans. The innovative smart phone application has made the use of CM for outpatient smoking cessation portable and feasible. The goal of this comparative effectiveness trial is to evaluate the effectiveness of a combined tele-health and mobile CM intervention that the investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose to screen 165 and randomize 126 homeless Veteran smokers to either:
ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM.
VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy.
Specific aims are to:
AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month post-randomization follow-ups.
AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY).
AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.
Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) symptoms on treatment outcome across the two conditions.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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North Carolina
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Durham、North Carolina、美国、27705
- Durham VA Medical Center, Durham, NC
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Veteran
- Homeless
- Enrolled in Durham VA Medical Center for medical care
- Current smoker (at least 10 cigarettes per day)
- Willing to quit smoking in the next 30 days
Exclusion Criteria:
- Active substance dependence other than nicotine
- Uncontrolled psychotic symptoms
- Severely impaired hearing or speech (must be able to respond to telephone calls)
- Lack of interest in receiving telephone care
- Pregnancy
学习计划
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:ART
Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.
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Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date.
Nicotine patches may be provided to control group participants as part of usual care.
其他名称:
Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking.
In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor.
Participants are trained to upload videos of themselves taking CO readings.
Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date.
Nicotine gum or lozenges may be provided to control group participants as part of usual care.
其他名称:
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date.
Bupropion may also be prescribed to control group participants as part of usual care.
其他名称:
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有源比较器:Control Group
Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
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Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date.
Nicotine patches may be provided to control group participants as part of usual care.
其他名称:
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date.
Nicotine gum or lozenges may be provided to control group participants as part of usual care.
其他名称:
Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date.
Bupropion may also be prescribed to control group participants as part of usual care.
其他名称:
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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 |
|---|---|---|
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Number of Participants Self-reported and Bioverified Abstinent From Smoking
大体时间:6 months
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Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intervention Delivery Costs
大体时间:6 months
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Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
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6 months
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合作者和调查者
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
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- D1301-R
- 1828 (其他标识符:VA IRB)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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