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

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ClinicalTrials.gov Identifier: NCT00218127
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE November 2001
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
drug use [ Time Frame: herion use over 20 week period ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Substance use and retention
Change History Complete list of historical versions of study NCT00218127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
Behavioral and pyschological measures during stable dosing and dose reduction
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens
Official Title  ICMJE Opioid Maintenance: Optimum Stabilization and Withdrawal
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heroin Dependence
  • Opioid-Related Disorders
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2005)
142
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00218127
Other Study ID Numbers  ICMJE NIDA-13664-1
R01-13664-1
DPMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party F. Gerard Moeller, M.D., University of Texas Medical School at Houston
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Grabowski, PhD The University of Texas Health Science Center, Houston
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date October 2016

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