跳至主要内容
临床试验/NCT00158288
NCT00158288已完成2 期

LAAM With Behavioral Treatment for Opioid/Cocaine Abuse

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 1997年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Urine toxicology for cocaine

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Urine toxicology for cocaine

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (2)

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