Smoking Cessation for People Living With HIV/AIDS
Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
In this proposed study with People Living with HIV/AIDS (PLWHA), we will use a stepped care model called a Sequential Multiple Assignment Randomized Trial (SMART) to examine the efficacy of low- and high-intensity smoking cessation treatments for nicotine dependent PLWHA that incorporate the current standard of care and prize-based contingency management. Intervention will be administered in a community-based HIV integrated care clinic in downtown Detroit, which has the highest prevalence rates of HIV/AIDS and smoking in Michigan. Phase 1 will last 4 weeks, and will involve brief intervention to help participants stop smoking. For phase 2, participants will be assigned to different study arms depending on whether they are Responders (reduced their smoking) or Non-responders (continued to smoke).
- Phase 1: We hypothesize that brief high-magnitude prize contingency management will result in greater reduction in smoking than standard of care alone.
- Phase 2a: We hypothesize that non-responders who are assigned to contingency management will be more likely to reduce their smoking throughout treatment and to abstain from smoking at all follow-up points.
- Phase 2b: We hypothesize that responders who are assigned to monitoring and low-magnitude prize contingency management will be more likely to maintain their reduced or abstinent smoking status at all follow-up time-points.
研究概览
地位
详细说明
All research related activities will take place at the Tolan Park Medical Building located at 3901 Chrysler Service Dr, Detroit, 48201.
Participants in Phase 1 will be randomized to one of two brief interventions based on standard of care guidelines (SoC): A) brief counseling and bupropion (SoC); or B) SoC plus brief high-magnitude prize CM (HM-CM). At the end of Phase 1, participants will be classified as responders or non-responders on the basis of smoking reduction/abstinence. All participants will continue to receive bupropion. Non-responders will enter Phase 2a and be randomly assigned to: A) continued counseling and monitoring support to quit smoking (MS); or B) MS plus prize CM for abstinence (MS+CM). Phase 1 responders will be entered into Phase 2b and randomly assigned to: A) no additional treatment (NAT); or B) Continued monitoring and low intensity prize CM (LI-CM). The primary dependent variables will include cotinine and carbon monoxide (CO) levels, and longest duration of abstinence from cigarettes. Seven-day point prevalence will be used to assess outcome at post-treatment, 6-month and 12-month follow-up points.
Participants will be paid $35 for intake and $25 for each follow-up interview, which will occur at post-phase 1, post-phase 2, and 6-months and 12-months after treatment initiation. Some assessments as well as treatment sessions will be recorded to ensure data quality.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Michigan
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Detroit、Michigan、美国、48201
- Tolan Park Medical Building
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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:
- Age 18 years or older
- Able to read and understand English
- Smoke more than 10 cigarettes/day
- Patient enrolled in the HIV clinic with HIV or AIDS diagnosis
Exclusion Criteria:
- Are actively suicidal or have uncontrolled manic or psychotic symptoms requiring immediate care
- Are in recovery for pathological gambling (PG)
- Have contraindications for bupropion treatment (e.g., presence of epilepsy or other seizure disorder, use of monoamine oxidase inhibitors or other antidepressants, presence of eating disorders or very low weight)
- Are already participating in other smoking cessation interventions.
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：Phase 1: Standard of Care (A)
Brief counseling and bupropion
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Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
其他名称：
Participants are provided with brief counseling for smoking cessation.
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实验性的：Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
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Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
其他名称：
Participants are provided with brief counseling for smoking cessation.
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
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实验性的：Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
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Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
其他名称：
Participants are provided with brief counseling for smoking cessation.
Brief supportive sessions and monitoring of smoking cessation efforts.
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实验性的：Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
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Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
其他名称：
Brief supportive sessions and monitoring of smoking cessation efforts.
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
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实验性的：Phase 2b: Responders (A)
Bupropion, no additional treatment.
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Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
其他名称：
No additional treatment will be given.
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实验性的：Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
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Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
其他名称：
Brief supportive sessions and monitoring of smoking cessation efforts.
Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
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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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Urinary Cotinine
大体时间：Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
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Urinary cotinine is a metabolite of nicotine, and can be detected in urine.
The presence of cotinine in urine shows recent cigarette smoking.
Cotinine is measured using an instant test that give a score from 0 to 6 on a semi-quantitative scale.
Declining scores show an individual has stopped or significantly reduced their smoking.
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Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
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Longest Duration of Continuous Abstinence
大体时间：Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
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This is the longest period of consecutive days during treatment where the participant has not smoked.
Longest duration of abstinence is calculated through self-report of smoking abstinence verified by scores on biological measures (negative scores on carbon monoxide or urinary cotinine tests).
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Change from baseline: Weekly through treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group)
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Seven-Day Point-Prevalence
大体时间：Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
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At each follow-up assessment, participants will be asked if they had smoked in the preceding seven days.
They will also participate in cotinine and carbon monoxide testing.
Negative scores are given when the participant reports no smoking and all tests are negative.
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Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
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Carbon Monoxide Results
大体时间：Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
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Participants will provide breath carbon monoxide samples at each visit by blowing into a hand-held carbon monoxide reader.
Carbon monoxide is produced when substances (such as cigarettes) are burned.
Thus this test can show if an individual has been smoking recently.
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Change from baseline: weekly in treatment phase 1; between 0 to 16 times during treatment phase 2 (non-responders meet 16 times; responders meet 0 or 6 times depending on group); Follow-up interviews (Post-phase 1, Post-phase 2, 6-months and 12-months)
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合作者和调查者
调查人员
- 首席研究员：David Ledgerwood, PhD、Wayne State University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
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