Placebo-Controlled Evaluation of the Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percentage of Positive Toxicology Swabs for Illicit Substances
研究概览
简要总结
This study examines whether isolated doses of d-cycloserine enhance the efficacy of an exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance dependence.
详细描述
This is a placebo-controlled trial of the efficacy of 50mg d-cycloserine or matching pill placebo for enhancing the efficacy of CBT.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients with significantly unstable or uncontrolled medical illness which may interfere with participation in treatment (e.g., patients likely to require hospitalization during the study period).
- •Patients with a psychotic or organic mental disorder according to DSM-IV criteria.
- •Patients receiving medication affecting methadone metabolism (e.g. rifampin).
- •Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria for mania or hypomania or meeting criteria for rapid cycling in the last year (as indicated by structured questioning of all patients meeting criteria for bipolar disorder).
- •Patients unable to complete the informed consent or unable to understand study procedures in the informed consent process.
- •Pregnancy or current alcohol use.
研究组 & 干预措施
DCS-augmented CBT-IC
D-cycloserine-augmented CBT-IC
干预措施: D-cycloserine (Drug)
Placebo-augmented CBT-IC
Placebo-augmented CBT-IC
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Positive Toxicology Swabs for Illicit Substances
时间窗: Weekly assessments with summation over three time periods: baseline, treatment (week 12), and follow-up (week 18)
The primary outcome assessment for this study was the percentage of oral toxicology swabs that were positive of illicit substances. Participants completed these swabs at each assessment point, as well as at each study therapy session. Toxicology swabs were supervised by study staff and used oral specimen collection to screen for opiates, methadone, cocaine, benzodiazepines, amphetamines, THC, and barbiturates.
次要结局
- Addiction Severity Index (ASI) Drug Use Composite Score(Baseline, Mid Treatment (week 6), End of Treatment (week 12), Follow-up 1 (week 15), Follow-up 2 (week 18))
研究者
Michael Otto
Ph.D.
Boston University Charles River Campus