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

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Department of Psychatiry, Mental Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • LAAM
Drug: Levoacetyl Methadol
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Other Names:
  • LAAM
Drug: Levoacetyl Methadol
LAAM Fixed Dose evaluation up to 48 mg 48 mg
Other Names:
  • LAAM
Experimental: 2
LAAM MaxEffect to 48 mg Adjust to effect (+/-)
Drug: Levoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Other Names:
  • LAAM
Drug: Levoacetyl Methadol
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Other Names:
  • LAAM
Drug: Levoacetyl Methadol
LAAM Fixed Dose evaluation up to 48 mg 48 mg
Other Names:
  • LAAM
Experimental: 3
LAAM Fixed Dose up to 48 mg 48 mg
Drug: Levoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Other Names:
  • LAAM
Drug: Levoacetyl Methadol
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Other Names:
  • LAAM
Drug: Levoacetyl Methadol
LAAM Fixed Dose evaluation up to 48 mg 48 mg
Other Names:
  • LAAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
drug use
Time Frame: herion use over 20 week period
herion use over 20 week period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: John Grabowski, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-13664-1
  • DPMC (Other Identifier: NIDA)
  • R01-13664-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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