Cocaine-Metyrapone Interaction Study - 1

NCT ID: NCT00033098

Last Updated: 2017-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2002-05-31

Brief Summary

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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

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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.

Conditions

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Cocaine-Related Disorders Infusions, Intravenous

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Metyrapone

Intervention Type DRUG

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cincinnati VA Medical Center

OTHER_GOV

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Theresa Winhusen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cincinnati VA Medical Center

Locations

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Cincinnati VA Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NIDA-CTO-0006-1

Identifier Type: -

Identifier Source: org_study_id

NCT00024778

Identifier Type: -

Identifier Source: nct_alias

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