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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


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
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