The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1
Condition: Behavior Therapy; Cocaine; Contingency Management; Heroin Dependence; LAAM; Opioid Dependence; Substance-Related Disorders; Alcohol & Drug Use
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders; Cocaine-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): LAAM
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Substance Use Disorders