Pharmacotherapy & CM for Opioid and Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of the combined treatment modafinil +
      Contingency Management (CM) to either treatment condition alone or to yoked-controls on
      cocaine abstinence.

      To investigate the role of modafinil-related improvements in memory, impulse control, and
      attention in mediating cocaine abstinence.
    

Detailed description: 
      We hypothesize that the treatment group receiving the combination of modafinil + Contingency
      Management will have significantly lower cocaine use than the other treatment conditions. We
      also hypothesize that improvements in memory, impulse control, and attention will be a
      significant contributor to the treatment improvements investigated in Specific Aim #1.

      Opioid and cocaine dependence are major problems among veteran and non-veterans and no
      effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust
      effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals
      who have developed cocaine dependence. This study is designed to test a new pharmacotherapy
      for cocaine dependence and is a placebo-controlled trial.
    

Intervention name(s): Modafinil; Sugar Pill; Contingency Management; Methadone; cognitive behavioral treatment; Voucher Control
Intervention type(s): Drug; Drug; Behavioral; Drug; Behavioral; Behavioral
Intervention description(s): Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study.; placebo, sugar pill will mirror active drug; Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample.; Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo.; All subjects will receive a manual-guided CBT treatment over the course of their 16-week participation. This manual-guided therapy promotes abstinence through a functional analysis of high-risk situations and coping skills training.; Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth.
Other intervention name(s): Placebo
Intervention MeSH terms: Methadone; Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment for addiction; Methadone given for opioid dependence; Cocaine; Opiates