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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218127
First received: September 16, 2005
Last updated: August 18, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Drug: Levoacetyl Methadol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Opioid Maintenance: Optimum Stabilization and Withdrawal

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • drug use [ Time Frame: herion use over 20 week period ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: November 2001
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218127

Locations
United States, Texas
Department of Psychatiry, Mental Services
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: John Grabowski, PhD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: F. Gerard Moeller, M.D., University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00218127     History of Changes
Other Study ID Numbers: NIDA-13664-1, R01-13664-1, DPMC
Study First Received: September 16, 2005
Last Updated: August 18, 2008
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Methadyl Acetate
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014