This trial is active, not recruiting.

Conditions cocaine-related disorders, infusions, intravenous
Treatment metyrapone
Phase phase 1
Sponsor National Institute on Drug Abuse (NIDA)
Collaborator Cincinnati VA Medical Center
Start date November 2001
End date May 2002
Trial size 12 participants
Trial identifier NCT00033098, NCT00024778, NIDA-CTO-0006-1


The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model crossover assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Cocaine craving
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Cocaine-Metyrapone Interaction Study
Principal investigator Theresa Winhusen, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).