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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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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Behavior Therapy Cocaine Contingency Management Heroin Dependence LAAM Opioid Dependence Substance-Related Disorders Alcohol & Drug Use | Behavioral: LAAM | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | LAAM With Behavioral Treatment for Opioid/Cocaine Abuse |
- Urine toxicology for cocaine
| Estimated Enrollment: | 140 |
| Study Start Date: | March 1997 |
| Estimated Study Completion Date: | August 2001 |
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.
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00158288
| United States, Connecticut | |
| VA Connecticut Healthcare System | |
| West Haven, Connecticut, United States, 06516 | |
| Principal Investigator: | Alison Oliveto, Ph.D. | Yale University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00158288 History of Changes |
| Other Study ID Numbers: |
NIDA-09876-1 R01-09876-1 |
| Study First Received: | September 8, 2005 |
| Last Updated: | January 11, 2017 |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Substance Use Disorders |
Additional relevant MeSH terms:
|
Substance-Related Disorders Heroin Dependence Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Opioid-Related Disorders Cocaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 23, 2017