Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management

Summary

Background:

\- The treatment of addiction often hinges on preventing relapse into drug-using behaviors, which occurs at high rates even after prolonged abstinence. Some methadone patients continue to abuse cocaine and heroin during treatment, even with extensive psychosocial services. More research is needed to look at the results from earlier studies of continued drug use during methadone treatment, focusing on the results of fixed vs. flexible doses of methadone to reduce the likelihood of continued drug use and the role of monetary vouchers as an incentive to continue abstinence from illicit substances.

Objectives:

\- To determine if the combination of flexible methadone dosing and voucher-based contingency management can improve rates of abstinence from heroin and cocaine.

Eligibility:

\- Individuals between 18 and 65 years of age or older who are dependent on opioids (cocaine and/or heroin).

Design:

* The study will last 40 weeks. After the initial screening, participants will receive daily methadone and weekly drug counseling sessions that will continue throughout the study.
* After 6 weeks of methadone treatment, participants who continue to use heroin and cocaine will be randomized to one of four groups for 16 weeks of study. Each group will receive a flexible or fixed dose of methadone, and one of two contingency management conditions.
* Flexible-dose participants will receive individualized dose increases, based on drug use and withdrawal. Fixed-dose participants will be set at a specific dose of methadone that will not be changed.
* The two contingency management conditions will be monetary vouchers given for regular cocaine-negative urine samples, or vouchers independent of urine cocaine screen results.
* After the study phase, participants will have 10 weeks of standard individual counseling and stable doses of methadone. Urine samples will continue to be collected, but no vouchers will be given.
* At the end of the study, participants will have the choice of transferring to a community clinic or undergoing a 10-week taper from methadone.

Conditions

• Opiate-Related Disorders
• Cocaine-Related Disorders

Interventions

DRUG

Methadone

100 mg/day orally

BEHAVIORAL

Contingency Management

Incentives given for cocaine abstinence

DRUG

Methadone dose

flexible methadone dosing to 190 mg/day daily orally

BEHAVIORAL

Contingency Management/Noncontingent Incentives

Incentives given independent of drug use

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

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-02-01

Primary Completion

2013-08-09

Completion

2013-08-09

Countries

• United States

Study Locations