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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00218127
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

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 individuals.

Condition or disease Intervention/treatment Phase
Heroin Dependence Opioid-Related Disorders Drug: Levoacetyl Methadol Phase 2

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 the efficacy of ORLAAM in treating heroin dependent individuals. In addition, this study will determine the most effective dosing regimen of ORLAAM.

This study will last 20 weeks. Participants will be randomly assigned to receive one of three dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal symptoms associated with opiate use; doses may be adjusted throughout the study. All participants will receive cognitive behavioral therapy throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioid Maintenance: Optimum Stabilization and Withdrawal
Study Start Date : November 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heroin

Arm Intervention/treatment
Experimental: 1
LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks
Drug: Levoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Other Name: LAAM

Experimental: 2
LAAM MaxEffect to 48 mg Adjust to effect (+/-)
Drug: Levoacetyl Methadol
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Other Name: LAAM

Experimental: 3
LAAM Fixed Dose up to 48 mg 48 mg
Drug: Levoacetyl Methadol
LAAM Fixed Dose evaluation up to 48 mg 48 mg
Other Name: LAAM

Primary Outcome Measures :
  1. drug use [ Time Frame: herion use over 20 week period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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)

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 identifier (NCT number): NCT00218127

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United States, Texas
Department of Psychatiry, Mental Services
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
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Principal Investigator: John Grabowski, PhD The University of Texas Health Science Center, Houston

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Responsible Party: F. Gerard Moeller, M.D., University of Texas Medical School at Houston Identifier: NCT00218127     History of Changes
Other Study ID Numbers: NIDA-13664-1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
Heroin dependence
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadyl Acetate
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents