A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting 7-day Point-prevalence Abstinence
研究概览
简要总结
The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- •Diagnosed with HIV (based on self-report).
- •Be 18 years and older
- •Have smoked ≥ 5 cigarettes/day in the past year
- •Be interested in making a quit attempt in the next 30 days
- •Own a smartphone (apple/android), and plan to keep it active for the next 6 months
- •Able to consent
- •Have no plans to move in the next 6 months
- •Are not pregnant or planning to be pregnant in the following 6 months
- •Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
排除标准
- •Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
- •Are currently being treated for a psychiatric condition.
- •Are currently being treated for smoking cessation, alcoholism, or illicit drug use
- •Are adults unable to consent
- •Are individuals who are not yet adults
- •Are pregnant women
- •Are prisoners
研究组 & 干预措施
MT plus NRT Group-Phase 1
Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
干预措施: Nicotine Replacement Therapy (Drug)
MT plus NRT Group-Phase 1
Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
干预措施: Mindfulness Training Smoking Cessation Intervention (Behavioral)
CM plus NRT Group-Phase1
Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
干预措施: Nicotine Replacement Therapy (Drug)
CM plus NRT Group-Phase1
Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
干预措施: Contingency Management Smoking Cessation Intervention (Behavioral)
MT plus NRT with additional CM Group-Phase2
Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
干预措施: Nicotine Replacement Therapy (Drug)
MT plus NRT with additional CM Group-Phase2
Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
干预措施: Mindfulness Training Smoking Cessation Intervention (Behavioral)
MT plus NRT with additional CM Group-Phase2
Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
干预措施: Contingency Management Smoking Cessation Intervention (Behavioral)
CM plus NRT with additional MT Group-Phase2
Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
干预措施: Nicotine Replacement Therapy (Drug)
CM plus NRT with additional MT Group-Phase2
Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
干预措施: Mindfulness Training Smoking Cessation Intervention (Behavioral)
CM plus NRT with additional MT Group-Phase2
Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
干预措施: Contingency Management Smoking Cessation Intervention (Behavioral)
结局指标
主要结局
Number of Participants Reporting 7-day Point-prevalence Abstinence
时间窗: 4 weeks (end of treatment), and 3 months
Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.
次要结局
- Retention Rate(3 months)
- Treatment Specific Adherence Rates(3 months)
研究者
Taghrid Asfar
Research Assistant Professor
University of Miami