Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

Anna Rose Childress, Ph.D.

Status and phase: Terminated; Phase 2

Conditions: Cocaine Use Disorder

Treatments: Drug: Cariprazine Oral Capsule [Vraylar]; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03430544

828585

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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, when applicable.

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, when applicable.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo oral capsule

1.5 mg/d cariprazine

Experimental group

Treatment:

Drug: Cariprazine Oral Capsule [Vraylar]

3.0 mg/d cariprazine

Experimental group

Treatment:

Drug: Cariprazine Oral Capsule [Vraylar]