Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/6/2018 |
| Start Date: | April 4, 2018 |
| End Date: | July 31, 2020 |
| Contact: | Stefanie Darnley, BS |
| Email: | stefd@pennmedicine.upenn.edu |
| Phone: | 2157462767 |
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
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 and behavioral task sessions. 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.
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 and behavioral task sessions. 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.
Inclusion Criteria (limited):
1. An informed consent voluntarily signed and dated by the subject.
2. Physically healthy males and females with cocaine use disorder.
3. Ability to read at or above eighth grade level and speak, understand, and write in
English.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.
5. Available for an inpatient stay.
Exclusion Criteria (limited):
1. Certain psychological disorders that could put subjects at risk during participation
in the study.
2. Certain lifetime or current medical disorders or conditions that could put subjects at
risk during participation in the study.
3. Medical contraindications for MRI.
4. Has received medication that could interact adversely with cariprazine within the time
of administration of study agent based on the study physician's guidance.
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-746-1820
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