Naltrexone in Treatment of Cocaine Dependence - 5

NCT ID: NCT00015080

Last Updated: 2017-01-16

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

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1995-05-31

Study Completion Date

1996-07-31

Brief Summary

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The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.

Detailed Description

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Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.

Conditions

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Cocaine-Related Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Naltrexone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Meet DSM-III-R criteria for cocaine dependency,
2. 18 to 65 years of age,
3. capable of understanding the study,
4. voluntarily signed consent,
5. male or non-pregnant female using approved form of birth control.

Exclusion Criteria

1. abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values),
2. opioid use within the last 7 days,
3. use of neuroleptics,
4. having a severe acute medical problem,
5. unable to complete psychiatric rating scales, or
6. judged by the investigator to be unlikely to comply with the study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cincinnati MDRU

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Principal Investigators

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Eugene Somoza, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Cincinnati MDRU

Locations

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Cincinnati MDRU

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Somoza, E., et al. A Double-Blind,Placebo Controlled Clinical Trial of Naltrexone as a Treatment for Cocaine Dependence. NIDA Research Monograph, 1998, 179, p. 295.. None

Reference Type BACKGROUND

Other Identifiers

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Y01-5-0012-5

Identifier Type: -

Identifier Source: secondary_id

NIDA-5-0012-5

Identifier Type: -

Identifier Source: org_study_id

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