CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
sugar pill +2 moredrug
Likely dose
Carvedilol 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00566969
NCT00566969N/ACompleted

Cocaine Withdrawal and Pharmacotherapy Response

Yale University·interventional·Posted Dec 4, 2007·Updated Apr 2, 2020

In Brief

A clinical study evaluating sugar pill, Carvedilol 25 mg, and 1 other intervention for Cocaine Dependence and Opiate Dependence. Completed, enrolled 106 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.6 years ago

Interventions

sugar pilldrug

Subjects randomized to placebo, carvedilol 25mg or 50mg

Carvedilol 25 mgdrug

subjects randomized to placebo, carvedilol 25mg or 50mg

Carvedilol 50 mgdrug

subjects randomized to placebo, carvedilol 25mg or 50mg