Cardiovascular, Immune and Psychosocial Benefits of Reduced Cocaine Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Endothelin-1 Levels
研究概览
简要总结
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced cocaine use. These data will be used to change current accepted cocaine treatment endpoints and accelerate identification of therapies for cocaine use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Self-report of recent cocaine use verified by a cocaine-positive urine sample
- •Meet moderate-severe Cocaine Use Disorder Criteria
- •Seeking treatment for their cocaine use
- •Able to commit to 12-week intervention, plus 24-week follow up
排除标准
- •History of serious physical or psychiatric disease (e.g., physical dependence on any drug requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, extreme hypersensitivity/allergy to candida yeast or similar products, severe diagnosis for other substance use disorder) that would interfere with study participation
- •Current physical or psychiatric disease that would interfere with study participation
- •Poor veinous access, precluding blood draws
研究组 & 干预措施
Control Group
This group will receive payment for providing urine samples throughout the trial.
Low Value Alternative Reinforcer Group
This group will receive payment for providing cocaine negative urine samples throughout the trial.
干预措施: Contingency Management (Behavioral)
High Value Alternative Reinforcer Group
This group will receive payment for providing cocaine negative urine samples throughout the trial.
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Endothelin-1 Levels
时间窗: Week 12 of study participation
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Mean Arterial Pressure
时间窗: Week 12 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Endothelin-1 Levels
时间窗: At baseline.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Endothelin-1 Levels
时间窗: Week 6 of study participation
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Mean Arterial Pressure
时间窗: At baseline
Mean Arterial Pressure is recorded during participant visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 1 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 2 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 3 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 4 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 5 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 6 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 7 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 8 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 9 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 10 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 11 of participation
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
次要结局
- Interleukin-10(Week 12 of study participation)
- Hamilton Depression Scale Score(Week 12 of Participation)
- Criteria for Cocaine Use Disorder Diagnosis(Week 12 of Participation)
- Total Sleep Time(Week 12 of participation)
- Reactive Hyperemia Index(Week 12 of participation)
- Total Sleep Time(Week 4 of participation)
- Interleukin-10(At baseline.)
- Interleukin-10(Week 6 of study participation)
- Total Sleep Time(At baseline)
- Total Sleep Time(Week 1 of participation)
- Total Sleep Time(Week 2 of participation)
- Total Sleep Time(Week 3 of participation)
- Total Sleep Time(Week 5 of participation)
- Total Sleep Time(Week 6 of participation)
- Total Sleep Time(Week 7 of participation)
- Total Sleep Time(Week 8 of participation)
- Total Sleep Time(Week 9 of participation)
- Total Sleep Time(Week 10 of participation)
- Total Sleep Time(Week 11 of participation)
- Hamilton Depression Scale Score(At baseline)
- Hamilton Depression Scale Score(Week 1 of Participation)
- Hamilton Depression Scale Score(Week 2 of Participation)
- Hamilton Depression Scale Score(Week 3 of Participation)
- Hamilton Depression Scale Score(Week 4 of Participation)
- Hamilton Depression Scale Score(Week 5 of Participation)
- Hamilton Depression Scale Score(Week 6 of Participation)
- Hamilton Depression Scale Score(Week 7 of Participation)
- Hamilton Depression Scale Score(Week 8 of Participation)
- Hamilton Depression Scale Score(Week 9 of Participation)
- Hamilton Depression Scale Score(Week 10 of Participation)
- Hamilton Depression Scale Score(Week 11 of Participation)
- Criteria for Cocaine Use Disorder Diagnosis(At Baseline)
- Reactive Hyperemia Index(At Baseline)
研究者
William Stoops
Professor
University of Kentucky