The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1

NCT00158288 | Completed Phase 2

• 2 other identifiers: NIDA-09876-1R01-09876-1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Although LAAM, a derivative of methadone, has been successfully used as an alternative to methadone maintenance in opioid addicts, its effect on concurrent opioid and cocaine abuse has not been ascertained. Thus, this study proposes to examine the clinical efficacy of low- and high-dose LAAM maintenance on opioid and cocaine use in opioid-dependent cocaine abusers. In addition, since contingency management procedures have demonstrated some success in decreasing cocaine use in cocaine-abusing individuals, this study also proposes to examine the clinical efficacy of the presence or absence of contingency management procedures targeting illicit drug use.

Conditions

Behavior Therapy; Cocaine; Contingency Management; Heroin Dependence; LAAM; Opioid Dependence; Substance-Related Disorders; Alcohol & Drug Use

Keywords

Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Urine toxicology for cocaine

Interventions

LAAM BEHAVIORAL

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• One hundred forty male and female cocaine-abusing, opioid-dependent individuals between the ages 21-55, with at least 40% women and 40% Afro-Americans, who not be currently enrolled in treatment, will be entered into the study. Subjects must have current opioid dependence as evidenced by documentation of prior treatment for opioid dependence or signs of withdrawal upon administration of naloxone (0.8 mg, i.m.), and opioid-positive urine screen. Subjects also must be current users of cocaine with self-reported use of \> 12 gms during the preceding 12 months, self-reported use of \> 1 gm/week in the month preceding study entry, and cocaine-positive urine screen. Subjects must fulfill DSM-III-R criteria for opioid and cocaine dependence. These criteria will be ascertained using the substance abuse section of the SCID interview developed for use with DSM-III-R

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead
• Yale University: collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

• Oliveto A, Poling J, Sevarino KA, Gonsai KR, McCance-Katz EF, Stine SM, Kosten TR. Efficacy of dose and contingency management procedures in LAAM-maintained cocaine-dependent patients. Drug Alcohol Depend. 2005 Aug 1;79(2):157-65. doi: 10.1016/j.drugalcdep.2005.01.007.

  PMID: 16002025 RESULT

MeSH Terms

Conditions

Heroin Dependence; Opioid-Related Disorders; Substance-Related Disorders

Interventions

Methadyl Acetate

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methadone; Ketones; Organic Chemicals

Study Officials

• Alison Oliveto, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: March 1, 1997
• Study Completion: August 1, 2001
• Last Updated: January 12, 2017

Record last verified: 2005-09

Locations

US (1)