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Cocaine-Metyrapone Interaction Study - 1 - Article


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Immune Globulin Intravenous Injection

Gamimune N; Gammagard S/D; Gammar-IV; Gammar-P I.V.; IGIV; Iveegam; Panglobulin; Polygam S/D; Sandoglobulin; Venoglobulin-S


Clinical Trial: Cocaine-Metyrapone Interaction Study - 1

This study is no longer recruiting patients.

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
VA Medical Center-Cincinnati
Information provided by: National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.

Condition Treatment or Intervention Phase
Cocaine-Related Disorders
Infusions, Intravenous
 Drug: Metyrapone
Phase I

MedlinePlus related topics:  Cocaine Abuse

Study Type: Interventional
Study Design: Treatment, Double-Blind, Placebo Control, Crossover Assignment

Official Title: Cocaine-Metyrapone Interaction Study

Further Study Details: 

Expected Total Enrollment:  12

Study start: November 2001;  Study completion: May 2002

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

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  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.


Location Information


Ohio
      Cincinnati VA Medical Center, Cincinnati,  Ohio,  45220,  United States

Study chairs or principal investigators

Theresa Winhusen, Ph.D.,  Principal Investigator,  VA Medical Center-Cincinnati   

More Information

Study ID Numbers:  NIDA-CTO-0006-1
Record last reviewed:  August 2003
Last Updated:  February 16, 2005
Record first received:  April 5, 2002
ClinicalTrials.gov Identifier:  NCT00033098
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: June 1, 2005
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