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Completed

NCT Number: NCT00015080

Naltrexone in Treatment of Cocaine Dependence - 5

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.

Completed

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati MDRU

Cincinnati, Ohio, 45220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Naltrexone

Drug

Primary outcomes

  1. Retention

  2. Cocaine use

  3. Depression

  4. Anxiety

  5. Addiction severity

  6. Global improvement

  7. Psychopathology

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • Cincinnati MDRU

Registry information

Official study title

Naltrexone in Treatment of Cocaine Dependence

Important dates

Study start
1995
Primary completion
1996
Study completion
1996
First posted
Apr 18, 2001
Registry last updated
Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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