drugset / Trial / NCT00566969

Cocaine Withdrawal and Pharmacotherapy Response

NCT00566969

RandomizedParallel-groupDouble-blindHealth-services research

Summary

A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The design will have two phases: 1) a four-week "treatment " phase; and 2) a 4 week " taper and detoxification or transfer" phase. Subjects will be cocaine users who are on stable doses of methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 2 to 4-week period based on an individual's needs, and they will concurrently be tapered off carvedilol.

Timeline

Start
2007-09
Primary completion
2012-12
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carvedilol Other / unclassified 25 mg
Comparator Carvedilol Other / unclassified 50 mg