Cocaine Withdrawal and Pharmacotherapy Response
Completed · Not applicable · Has a placebo group
Conditions studied: Cocaine Dependence, Opiate Dependence
In brief
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.
Key facts
- Study ID
- NCT00566969
- Run by
- Yale University
- People needed
- 106
- Starts
- 2007-09-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2020-04-02
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Current opioid dependence as evidenced by documented prior treatment for opioid dependence or signs of opiate withdrawals, self-reported history of opioid dependence for a consecutive 12 month period and a positive urine for opiates.
- Current cocaine use with self-reported use of cocaine > 1 time/week in at least on month preceding study entry, provision of a cocaine-positive urine and fulfilled DSM-IV criteria for cocaine dependence
- For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.
You may not qualify if…
- current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco);
- serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, hepatic disorders;
- current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts;
- screening liver function tests (AST or ALT) greater than 3 times normal;
- known allergy or intolerance for carvedilol or methadone.
Where it is running
- Veterans Hospital — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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