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Cocaine-Metyrapone Interaction Study - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00033098
Recruitment Status : Unknown
Verified August 2003 by National Institute on Drug Abuse (NIDA).
Recruitment status was:  Active, not recruiting
First Posted : April 8, 2002
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Cincinnati VA Medical Center
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE April 5, 2002
First Posted Date  ICMJE April 8, 2002
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE November 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Cocaine craving
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Cocaine-Related Disorders
  • Infusions, Intravenous
Intervention  ICMJE Drug: Metyrapone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June 23, 2005)
12
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2002
Primary Completion Date Not Provided
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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00033098
Other Study ID Numbers  ICMJE NIDA-CTO-0006-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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
PRS Account 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