NCT00218127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

3.7 years

First QC Date

September 16, 2005

Last Update Submit

January 11, 2017

Conditions

Heroin DependenceOpioid-Related Disorders

Keywords

Heroin dependence

Outcome Measures

Primary Outcomes (1)

  • drug use

    herion use over 20 week period

Study Arms (3)

1

EXPERIMENTAL

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

Drug: Levoacetyl Methadol

2

EXPERIMENTAL

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

Drug: Levoacetyl Methadol

3

EXPERIMENTAL

LAAM Fixed Dose up to 48 mg 48 mg

Drug: Levoacetyl Methadol

Interventions

Levoacetyl MethadolDRUG

WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day

Also known as: LAAM
1

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current opiate dependence
  • Provides acceptable proof of identity
  • History of 5 or more years of regular heroin use or dependence
  • Reads and writes English

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychatiry, Mental Services

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Heroin DependenceOpioid-Related Disorders

Interventions

Methadyl Acetate

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MethadoneKetonesOrganic Chemicals

Study Officials

  • John Grabowski, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

November 1, 2001

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)