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

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.

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.