Behavioral Smoking Cessation Treatment for People Living With HIV/AIDS
试验速览
- 阶段
- 不适用
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Urinary Cotinine
研究概览
简要总结
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.
详细描述
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 80 Years（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 read and understand English
- •Smoke more than 10 cigarettes/day
- •Patient enrolled in the HIV clinic with HIV or AIDS diagnosis
排除标准
- •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.
研究组 & 干预措施
Phase 1: Standard of Care (A)
Brief counseling and bupropion
干预措施: Bupropion (Drug)
Phase 1: Standard of Care (A)
Brief counseling and bupropion
干预措施: Brief Counseling (Behavioral)
Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
干预措施: Bupropion (Drug)
Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
干预措施: Brief Counseling (Behavioral)
Phase 1: Standard of Care (B)
Brief counseling, bupropion, and brief high-magnitude prize contingency management.
干预措施: High-magnitude prize contingency management (Behavioral)
Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
干预措施: Bupropion (Drug)
Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
干预措施: Brief Counseling (Behavioral)
Phase 2a Non-Responders (A)
Bupropion, continued counseling, monitored support to quit smoking.
干预措施: Monitored support to quit smoking (Behavioral)
Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
干预措施: Bupropion (Drug)
Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
干预措施: Monitored support to quit smoking (Behavioral)
Phase 2a: Non-Responders (B)
Bupropion, monitored support to quit smoking, prize contingency management for abstinence.
干预措施: Prize contingency management for abstinence (Behavioral)
Phase 2b: Responders (A)
Bupropion, no additional treatment.
干预措施: Bupropion (Drug)
Phase 2b: Responders (A)
Bupropion, no additional treatment.
干预措施: No additional treatment (Behavioral)
Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
干预措施: Bupropion (Drug)
Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
干预措施: Monitored support to quit smoking (Behavioral)
Phase 2b: Responders (B)
Bupropion, continued monitoring and low intensity prize contingency management.
干预措施: Low intensity prize contingency management (Behavioral)
结局指标
主要结局
Urinary Cotinine
时间窗: 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)
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.
Longest Duration of Continuous Abstinence
时间窗: 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)
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).
Seven-Day Point-Prevalence
时间窗: Follow-up interviews: Post-phase 1, Post-phase 2, 6-months and 12-months after treatment initiation.
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.
Carbon Monoxide Results
时间窗: 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)
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.
次要结局
未报告次要终点
研究者
David Ledgerwood
Associate Professor
Wayne State University