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

Opioid-Related Disorders Clinical Trial

Official title:

Opioid Maintenance: Optimum Stabilization and Withdrawal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218127
• Other study ID #: NIDA-13664-1
• Secondary ID: R01-13664-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 11, 2017
• Start date: November 2001
• Est. completion date: July 2005

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Levoacetyl Methadol
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
• Levoacetyl Methadol
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
• Levoacetyl Methadol
LAAM Fixed Dose evaluation up to 48 mg 48 mg

Locations

Country	Name	City	State
United States	Department of Psychatiry, Mental Services	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drug use		herion use over 20 week period	No