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Naltrexone in Treatment of Cocaine Dependence - 5

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ClinicalTrials.gov Identifier: NCT00015080
Recruitment Status : Completed
First Posted : April 18, 2001
Last Update Posted : January 16, 2017
Sponsor:
Collaborator:
Cincinnati MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Naltrexone Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: Naltrexone in Treatment of Cocaine Dependence
Study Start Date : May 1995
Actual Primary Completion Date : June 1996
Actual Study Completion Date : July 1996

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Retention
  2. Cocaine use
  3. Depression
  4. Anxiety
  5. Addiction severity
  6. Global improvement
  7. Psychopathology


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00015080


Locations
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United States, Ohio
Cincinnati MDRU
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Cincinnati MDRU
Investigators
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Principal Investigator: Eugene Somoza, M.D., Ph.D. Cincinnati MDRU
Publications:
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

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ClinicalTrials.gov Identifier: NCT00015080    
Other Study ID Numbers: NIDA-5-0012-5
Y01-5-0012-5
First Posted: April 18, 2001    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: December 1996
Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents