Cariprazine Effects on Brain and Behavior in Cocaine Use Disorder

NCT ID: NCT03430544

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-04
• Study Completion Date: 2020-09-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: 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.

1.5 mg/d cariprazine

Group Type: EXPERIMENTAL

Cariprazine Oral Capsule [Vraylar]

Intervention Type: 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).

3.0 mg/d cariprazine

Group Type: EXPERIMENTAL

Cariprazine Oral Capsule [Vraylar]

Intervention Type: 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).

Interventions

Cariprazine Oral Capsule [Vraylar]

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).

Intervention Type: DRUG

Placebo oral capsule

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Anna Rose Childress, Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Anna Rose Childress, Ph.D.

Research Professor of Psychology in Psychiatry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anna Rose Childress, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

828585

Identifier Type: -

Identifier Source: org_study_id