Cocaine-Metyrapone Interaction Study - 1
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine-Related Disorders; Infusions, Intravenous
Intervention: Metyrapone (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
Theresa Winhusen, Ph.D., Principal Investigator, Affiliation: Cincinnati VA Medical Center
Summary
The purpose of this study is to examine the safety of two consecutive days of metyrapone
(MRP) in subjects who may use cocaine concurrently.
Clinical Details
Official title: Cocaine-Metyrapone Interaction Study
Study design: Treatment, Double-Blind, Placebo Control, Crossover Assignment
Primary outcome: Cocaine craving
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Cincinnati VA Medical Center, Cincinnati, Ohio 45220, United States
Additional Information
Starting date: November 2001
Ending date: May 2002
Last updated: October 23, 2007
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