A Randomized, Single-blind, Placebo-controlled Phase II Study to Assess the Effects of Cariprazine on Brain and Behavior in Subjects With Cocaine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues.
研究概览
简要总结
This is a phase II, randomized, single-blind, placebo-controlled study to examine whether cariprazine (1.5 or 3 mg/d) 1) alters brain and/or behavioral responses to probes of reward and inhibition and 2) decreases cocaine use in individuals with cocaine use disorder. Subjects will be tested as inpatients during fMRI sessions. After the 2-week inpatient/medication induction phase, study medication will continue for 8 outpatient weeks, during which time cocaine use will be tracked. Subjects will be monitored during a 4-wk followup phase thereafter.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 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
- 未提供
研究组 & 干预措施
Placebo
干预措施: Placebo oral capsule (Drug)
1.5 mg/d cariprazine
干预措施: Cariprazine Oral Capsule [Vraylar] (Drug)
3.0 mg/d cariprazine
干预措施: Cariprazine Oral Capsule [Vraylar] (Drug)
结局指标
主要结局
Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues.
时间窗: Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment.
The primary fMRI outcome is the extracted BOLD signal change during visual stimuli reminiscent of cocaine (i.e., cocaine cues) in an a priori circuit-level ROI.
Primary clinical outcome measure - percentage of urines cocaine-positive or missing during outpatient phase.
时间窗: Urines are collected 3x per week during the 8 week outpatient phase.
The primary clinical outcome is percentage of urines cocaine-positive or missing (assessed by urines positive for benzoylecgonine (BE), a metabolite of cocaine) throughout the outpatient treatment phase \[Urines are counted as BE-positive if BE exceeds 300 ng/ml or if they are missing (no sample provided for a time point)\].
次要结局
- Secondary fMRI outcome measure - BOLD signal change during attempted inhibition of cue-triggered drug craving.(Collected during fMRI scan 2, which takes place approximately 13-14 days after subject enrollment.)
- Attentional bias scores(Completed on approximately day 14-15 after subject enrollment.)
- Affective bias scores(Completed on approximately day 14-15 after subject enrollment.)
- Balloon Analogue Risk Task scores(Completed on approximately day 14-15 after subject enrollment.)
- Go-NoGo Task scores(Completed on approximately day 14-15 after subject enrollment.)
研究者
Anna Rose Childress, Ph.D.
Research Professor of Psychology in Psychiatry
University of Pennsylvania