Cocaine-Metyrapone Interaction Study - 1
This trial is active, not recruiting.
|Conditions||cocaine-related disorders, infusions, intravenous|
|Sponsor||National Institute on Drug Abuse (NIDA)|
|Collaborator||Cincinnati VA Medical Center|
|Start date||November 2001|
|End date||May 2002|
|Trial size||12 participants|
|Trial identifier||NCT00033098, NCT00024778, NIDA-CTO-0006-1|
The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.
|Intervention model||crossover assignment|
Male or female participants from 18 years up to 45 years old.
Inclusion Criteria: Male or Females between 18 and 45 yrs of age; cocaine dependence according to DSM-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments. Exclusion Criteria: Additional criteria available during screening at the site.
|Official title||Cocaine-Metyrapone Interaction Study|
|Principal investigator||Theresa Winhusen, Ph.D.|
|Description||To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week. Secondary study goals are to evaluate the possible efficacy of MRP as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. This study will utilize a Double Blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.|
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