Cocaine-Metyrapone Interaction Study - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 5, 2002

Last Updated Date

October 23, 2007

Start Date ^ICMJE

November 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cocaine craving

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00033098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Cocaine-Metyrapone Interaction Study - 1

Official Title ^ICMJE

Cocaine-Metyrapone Interaction Study

Brief 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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Cocaine-Related Disorders
Infusions, Intravenous

Intervention ^ICMJE

Drug: Metyrapone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

May 2002

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00033098

Responsible Party

Study ID Numbers ^ICMJE

NIDA-CTO-0006-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Cincinnati VA Medical Center

Investigators ^ICMJE

Principal Investigator:

Theresa Winhusen, Ph.D.

Cincinnati VA Medical Center

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP