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

Primary Purpose

Heroin Dependence, Opioid-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levoacetyl Methadol
Levoacetyl Methadol
Levoacetyl Methadol
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring Heroin dependence

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Psychatiry, Mental Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks

LAAM MaxEffect to 48 mg Adjust to effect (+/-)

LAAM Fixed Dose up to 48 mg 48 mg

Outcomes

Primary Outcome Measures

drug use

Secondary Outcome Measures

Full Information

First Posted
September 16, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218127
Brief Title
Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens
Official Title
Opioid Maintenance: Optimum Stabilization and Withdrawal
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Opioid-Related Disorders
Keywords
Heroin dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
LAAM WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day for 20 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
LAAM MaxEffect to 48 mg Adjust to effect (+/-)
Arm Title
3
Arm Type
Experimental
Arm Description
LAAM Fixed Dose up to 48 mg 48 mg
Intervention Type
Drug
Intervention Name(s)
Levoacetyl Methadol
Other Intervention Name(s)
LAAM
Intervention Description
WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Levoacetyl Methadol
Other Intervention Name(s)
LAAM
Intervention Description
MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-)
Intervention Type
Drug
Intervention Name(s)
Levoacetyl Methadol
Other Intervention Name(s)
LAAM
Intervention Description
LAAM Fixed Dose evaluation up to 48 mg 48 mg
Primary Outcome Measure Information:
Title
drug use
Time Frame
herion use over 20 week period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Grabowski, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychatiry, Mental Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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