Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients

Summary

Background:

* The effectiveness of methadone maintenance for treatment of heroin addiction has been well established. However, patients maintained on methadone may relapse to cocaine use, even when they are enrolled in a comprehensive treatment program. Relapse has been attributed to several factors, including drug-associated environmental stimuli.
* Aripiprazole is a drug used to treat schizophrenia and bipolar disorder, but it may have other uses. Research has shown that aripiprazole can reduce cocaine-seeking behavior in rats, and it has been investigated for use in treating amphetamine dependence. More research is needed to determine whether aripiprazole can prevent relapse to cocaine use in patients being treated with methadone.

Objectives:

\- To determine whether aripiprazole prevents relapse to cocaine use more effectively than placebo in cocaine-abstinent patients maintained on methadone.

Eligibility:

\- Individuals between 18 and 60 years of age who are current cocaine users seeking methadone treatment.

Design:

* The study will last up to 41 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers.
* Patients will be stabilized on daily methadone over the first 14 days of the study.
* Weeks 1 14: Participants will receive vouchers for regular cocaine-free urine samples. Those who successfully complete this phase will continue to the next part of the study.
* Weeks 13 27: Participants will receive either aripiprazole or placebo along with their methadone. During this part of the study, participants will keep electronic diaries to record cocaine use or craving and to record data on mood and activity.
* Weeks 28 33: Participants will stop taking the aripiprazole or placebo, but will continue the methadone treatment. Participants will continue to use the electronic diaries.
* Weeks 34 41: Participants will have the choice of transferring to a community clinic or gradually reducing doses of methadone to end the study.
* Participants will return for a follow-up visit and urine sample 6 months after the end of the study.

Conditions

• Cocaine Dependence
• Cocaine-Related Disorders
• Opioid-Related Disorders

Interventions

DRUG

Airipiprazole

Participants receive aripiprazole (orally, up to 15 mg/day) plus standard methadone maintenance (daily oral methadone and weekly individual counseling).

DRUG

Placebo

Participants receive identical capsules containing no active medication plus standard methadone maintenance (daily oral methadone and weekly individual counseling).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  lead NIH

Principal Investigators

• Kenzie Preston, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-05-08

Primary Completion

2013-04-16

Completion

2013-04-16

Countries

• United States

Study Locations