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

September 16, 2005
August 18, 2008
November 2001
July 2005   (final data collection date for primary outcome measure)
drug use [ Time Frame: herion use over 20 week period ] [ Designated as safety issue: No ]
Substance use and retention
Complete list of historical versions of study NCT00218127 on ClinicalTrials.gov Archive Site
Not Provided
Behavioral and pyschological measures during stable dosing and dose reduction
Not Provided
Not Provided
 
Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens
Opioid Maintenance: Optimum Stabilization and Withdrawal

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heroin Dependence
  • Opioid-Related Disorders
  • Drug: Levoacetyl Methadol
    WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
    Other Name: LAAM
  • Drug: Levoacetyl Methadol
    MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
    Other Name: LAAM
  • Drug: Levoacetyl Methadol
    LAAM Fixed Dose evaluation up to 48 mg 48 mg
    Other Name: LAAM
  • Experimental: 1
    LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks
    Intervention: Drug: Levoacetyl Methadol
  • Experimental: 2
    LAAM MaxEffect to 48 mg Adjust to effect (+/-)
    Intervention: Drug: Levoacetyl Methadol
  • Experimental: 3
    LAAM Fixed Dose up to 48 mg 48 mg
    Intervention: Drug: Levoacetyl Methadol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
July 2005
July 2005   (final data collection date for primary outcome measure)

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)
Both
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00218127
NIDA-13664-1, R01-13664-1, DPMC
Yes
F. Gerard Moeller, M.D., University of Texas Medical School at Houston
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: John Grabowski, PhD The University of Texas Health Science Center, Houston
National Institute on Drug Abuse (NIDA)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP