Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder
- Conditions
- Cocaine Use Disorder
- Interventions
- Drug: Placebo oral capsule
- Registration Number
- NCT03430544
- Lead Sponsor
- Anna Rose Childress, Ph.D.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1.5 mg/d cariprazine Cariprazine Oral Capsule [Vraylar] - 3.0 mg/d cariprazine Cariprazine Oral Capsule [Vraylar] - Placebo Placebo oral capsule -
- Primary Outcome Measures
Name Time Method Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues. 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. 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 \[Urines are counted as BE-positive if BE exceeds 300 ng/ml or if they are missing (no sample provided for a time point)\].
- Secondary Outcome Measures
Name Time Method 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. The secondary fMRI outcome is the extracted BOLD signal change during attempted inhibition of cue-triggered drug craving in an a priori ROI .
Attentional bias scores Completed on approximately day 14-15 after subject enrollment. Attentional bias scores derived from reaction time (msec) during attentional bias task
Affective bias scores Completed on approximately day 14-15 after subject enrollment. Affective bias scores derived from reaction time (msec) during affective bias task
Balloon Analogue Risk Task scores Completed on approximately day 14-15 after subject enrollment. # of average adjusted pumps on BART
Go-NoGo Task scores Completed on approximately day 14-15 after subject enrollment. # of errors of commission
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States