Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

NCT03430544 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: 828585
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Use Disorder

Keywords

cariprazine; fMRI; D3 receptor; cocaine use disorder; urine

Outcome Measures

Primary Outcomes (2)

• Primary fMRI outcome measure - BOLD signal change during visual cocaine vs. neutral cues.

  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.

  Collected during fMRI scan 1, which takes place approximately 12-13 days after subject enrollment.

• Primary clinical outcome measure - percentage of urines cocaine-positive or missing during 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 \[Urines are counted as BE-positive if BE exceeds 300 ng/ml or if they are missing (no sample provided for a time point)\].

  Urines are collected 3x per week during the 8 week outpatient phase.

Secondary Outcomes (5)

• 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.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule

1.5 mg/d cariprazine

EXPERIMENTAL

Drug: Cariprazine Oral Capsule [Vraylar]

3.0 mg/d cariprazine

EXPERIMENTAL

Drug: Cariprazine Oral Capsule [Vraylar]

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).

1.5 mg/d cariprazine; 3.0 mg/d cariprazine

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent voluntarily signed and dated by the subject.
• Physically healthy males and females with cocaine use disorder.
• Ability to read at or above eighth grade level and speak, understand, and write in English.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Available for an inpatient stay, when applicable.

You may not qualify if:

• Certain psychological disorders that could put subjects at risk during participation in the study.
• Certain lifetime or current medical disorders or conditions that could put subjects at risk during participation in the study.
• Medical contraindications for MRI, when applicable.
• Has received medication that could interact adversely with cariprazine within the time of administration of study agent based on the study physician's guidance.

Sponsors & Collaborators

• Anna Rose Childress, Ph.D.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

cariprazine

Study Officials

• Anna Rose Childress, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor of Psychology in Psychiatry

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 13, 2018
• Study Start: April 4, 2018
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (1)