Cocaine-Metyrapone Interaction Study - 1

This study is ongoing, but not recruiting participants.

First Received: April 5, 2002 Last Updated: October 23, 2007 History of Changes

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Cincinnati VA Medical Center
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00033098

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

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Cocaine-Metyrapone Interaction Study

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride Metyrapone

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Cocaine craving

Estimated Enrollment:	12
Study Start Date:	November 2001
Estimated Study Completion Date:	May 2002

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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033098

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Cincinnati VA Medical Center

Investigators

Principal Investigator:

Theresa Winhusen, Ph.D.

Cincinnati VA Medical Center

More Information

No publications provided

Study ID Numbers:	NIDA-CTO-0006-1
Study First Received:	April 5, 2002
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00033098 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Antimetabolites
Cocaine-Related Disorders
Metyrapone
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Antimetabolites
Cocaine-Related Disorders
Molecular Mechanisms of Pharmacological Action
Metyrapone
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009