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

Primary Purpose

Behavior Therapy, Cocaine, Contingency Management

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LAAM
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behavior Therapy focused on measuring Substance Use Disorders

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Criteria for exclusion include current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco); ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder); respiratory condition (e.g., asthma); history of major psychiatric disorder (psychosis, schizophrenia, bipolar, major depression); current suicidality; LFT's (i.e., liver enzymes) greater than 3 times normal levels; and pregnancy.

Sites / Locations

  • VA Connecticut Healthcare System

Outcomes

Primary Outcome Measures

Urine toxicology for cocaine

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00158288
Brief Title
The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1
Official Title
LAAM With Behavioral Treatment for Opioid/Cocaine Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Yale University

4. Oversight

5. Study Description

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.
Detailed Description
One hundred forty male and female opioid-dependent cocaine abusers will be stratified by sex and randomly assigned to one of four treatment groups according to a 2 x 2 experimental design: low-dose LAAM (99 mg/wk) with adjunct contingency management procedures; low-dose LAAM (99 mg/wk) without adjunct contingency management procedures; high-dose LAAM (330 mg/wk) with adjunct contingency management procedures; and high-dose LAAM (330 mg/wk) without adjunct contingency management procedures. The duration of the study will be 24 weeks, with LAAM being administered on a thrice-weekly (MWF) basis. Subjects are inducted onto LAAM during weeks 1-3 and then maintained on their assigned maintenance dose (99 mg/wk or 330 mg/wk) through week 24. During maintenance, the Friday dose will be 1.3 times greater than the Monday and Wednesday dose. At the conclusion of the study, subjects undergo detoxification from LAAM over a 4-week period. For those in the contingency management procedure group, each drug-free urine submitted will result in a voucher worth a certain monetary value that increases for consecutively drug-free urines (weeks 1-12) or a monetary voucher with a fixed value (weeks 13-24). Subjects not assigned to the contingency management procedure will receive monetary vouchers (weeks 1-24) according to a yoked-control schedule (that is, not contingent upon illicit drug abstinence). Vouchers can be exchanged for mutually agreed upon goods and services at any time during the study. Outcome measures will include: 1) treatment retention, 2) illicit drug use, 3) self-reported adverse and opioid withdrawal symptoms, and 4) psychosocial functioning. Follow-up interviews at nine months and/or one year post-study entry will be conducted to determine status post-treatment. Prognostic factors (i.e., sex, post-traumatic stress disorder, and depression), will also be examined in relation to treatment outcome and post-treatment status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Therapy, Cocaine, Contingency Management, Heroin Dependence, LAAM, Opioid Dependence, Substance-Related Disorders, Alcohol & Drug Use
Keywords
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
LAAM
Primary Outcome Measure Information:
Title
Urine toxicology for cocaine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Criteria for exclusion include current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco); ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder); respiratory condition (e.g., asthma); history of major psychiatric disorder (psychosis, schizophrenia, bipolar, major depression); current suicidality; LFT's (i.e., liver enzymes) greater than 3 times normal levels; and pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16002025
Citation
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.
Results Reference
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The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1

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