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Cocaine-Metyrapone Interaction Study - 1

Primary Purpose

Cocaine-Related Disorders, Infusions, Intravenous

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metyrapone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati VA Medical Center

Outcomes

Primary Outcome Measures

Cocaine craving

Secondary Outcome Measures

Full Information

First Posted
April 5, 2002
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00033098
Brief Title
Cocaine-Metyrapone Interaction Study - 1
Official Title
Cocaine-Metyrapone Interaction Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2003
Overall Recruitment Status
Unknown status
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Cincinnati VA Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-Related Disorders, Infusions, Intravenous

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Metyrapone
Primary Outcome Measure Information:
Title
Cocaine craving

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, Ph.D.
Organizational Affiliation
Cincinnati VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati VA Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cocaine-Metyrapone Interaction Study - 1

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