N/A
N=106
Cocaine Withdrawal and Pharmacotherapy Response
Cocaine Dependence · Opiate Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00566969 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Percent Days Abstinent From Cocaine - Self Report — 72.9; 72.9; 59.3 percentage of days — p=.10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- sugar pill (Drug); Carvedilol 25 mg (Drug); Carvedilol 50 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Days Abstinent From Cocaine - Self Report |
72.9; 72.9; 59.3 | .10 |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00566969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.