Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Anna Rose Childress, Ph.D.
Study ID
NCT03430544
Phase
PHASE2
Status
Terminated

Conditions

  • Cocaine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine Oral Capsule [Vraylar] — DRUG
    Cariprazine Groups (1.5 or 3mg/d): Cariprazine (VRAYLAR) capsules will be administered orally, once per day. Subjects in the 1.5mg group will receive 1 VRAYLAR capsule containing 1.5 mg cariprazine each day that study drug is administered. Subjects in the 3 mg group will be gradually titrated up to full dose: they will receive 1 VRAYLAR capsule containing 1.5mg cariprazine on the first and second days that study drug is administered and will receive 1 VRAYLAR capsule containing 3mg cariprazine each day for the rest of the medication period. The study medication period begins during the inpatient/induction phase and ends on the last day of outpatient treatment week 8 (approx. 10 weeks total). All VRAYLAR capsules will be over-encapsulated by the University of Pennsylvania Investigational Drug Services (IDS).
  • Placebo oral capsule — DRUG
    PLACEBO Group: Visually identical placebo capsules will be supplied by the University of Pennsylvania Investigational Drug Service, with a dosing regimen matching the cariprazine groups.

Study Details

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.

Key Dates

Start date
Apr 4, 2018
Status verified
Sep 2020
Primary completion
Sep 4, 2020
Completion
Sep 4, 2020

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: 1.5 mg/d cariprazine
  • Experimental: 3.0 mg/d cariprazine

Primary Outcome Measure

Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues. [ Time Frame: Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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