Status:

COMPLETED

Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens

Lead Sponsor:

National Institute on Drug Abuse (NIDA)

Conditions:

Heroin Dependence

Opioid-Related Disorders

Eligibility:

All Genders

25-55 years

Phase:

PHASE2

Brief Summary

Heroin dependence remains a major addiction problem in the United States. The purpose of this study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin dependent indiv...

Detailed Description

Heroin is a highly addictive drug, and its abuse has both medical and social consequences. ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is to determine th...

Eligibility Criteria

Inclusion

  • Current opiate dependence
  • Provides acceptable proof of identity
  • History of 5 or more years of regular heroin use or dependence
  • Reads and writes English

Exclusion

  • Significant suicidal or homicidal ideation, intent, or plan
  • Current AXIS I psychotic, depressive, or anxiety disorder
  • Meets DSM-IV criteria for dependence on any drug other than nicotine
  • Impending legal complications or incarceration
  • On parole or probation that requires reports of drug use or research data
  • Currently receiving treatment for opiate dependence
  • Currently participating in a 12-step substance detoxification program
  • Medical condition that contraindicates administration of ORLAAM
  • Plans to leave Houston, Texas within the year following study entry
  • Pregnant or breastfeeding
  • History of heart problems, including heart arrhythmias
  • Requires psychotropic medications (e.g., antidepressants, antipsychotics, anxiolytics)

Key Trial Info

Start Date :

November 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2005

Estimated Enrollment :

142 Patients enrolled

Trial Details

Trial ID

NCT00218127

Start Date

November 1 2001

End Date

July 1 2005

Last Update

January 12 2017

Active Locations (1)

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1

Department of Psychatiry, Mental Services

Houston, Texas, United States, 77030