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Cocaine-Metyrapone Interaction Study - 1

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2003 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cincinnati VA Medical Center
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00033098
First received: April 5, 2002
Last updated: October 23, 2007
Last verified: August 2003
History of Changes
  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 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cocaine-Metyrapone Interaction Study

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
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

ClinicalTrials.gov Identifier: NCT00033098     History of Changes
Obsolete Identifiers: NCT00024778
Other Study ID Numbers: NIDA-CTO-0006-1
Study First Received: April 5, 2002
Last Updated: October 23, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Metyrapone
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013