Cocaine-Metyrapone Interaction Study - 1

Cocaine-Related Disorders Clinical Trial

Official title:

Cocaine-Metyrapone Interaction Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00033098
• Other study ID #: NIDA-CTO-0006-1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 5, 2002
• Last updated: January 10, 2017
• Start date: November 2001
• Est. completion date: May 2002

Study information

• Verified date: August 2003
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00024778

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: May 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Infusions, Intravenous

Intervention

Drug:
• Metyrapone

Locations

Country	Name	City	State
United States	Cincinnati VA Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Cincinnati VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cocaine craving