NCT00292110

Treatment of Heroin and Cocaine With Methadone Maintenance and Contingency Management

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing Methadone in Opiate-Related Disorders in 140 participants. Completed in 9 August 2013.

Timeline

1 February 2004

Primary endpoint
9 August 2013

9 August 2013

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	140
Start date	1 February 2004
Primary completion	9 August 2013
Estimated completion	9 August 2013
Sites	1 location across United States

Drugs / interventions tested

• Methadone (METHADONE) — full drug profile →
• Contingency Management
• Methadone dose
• Contingency Management/Noncontingent Incentives

Conditions studied

• Opiate-Related Disorders — all drugs for Opiate-Related Disorders →
• Cocaine-Related Disorders — all drugs for Cocaine-Related Disorders →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 65, any sex, with Opiate-Related Disorders or Cocaine-Related Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychosocial interventions for psychostimulant misuse.
   Minozzi S, Saulle R, De Crescenzo F, Amato L. · · 2016 · cited 53× · PMID 27684277 · DOI 10.1002/14651858.cd011866.pub2
2. Psychosocial interventions for stimulant use disorder.
   Minozzi S, Saulle R, Amato L, Traccis F, et al · · 2024 · cited 15× · PMID 38357958 · DOI 10.1002/14651858.cd011866.pub3