NCT00344812

Brief Summary

A 17 week, double-blind, randomized, parallel group, four arm design outpatient study comparing LAAM, buprenorphine and two dose levels of methadone for the treatment of opioid dependence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1996

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1998

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2006

Completed
Last Updated

June 27, 2006

Status Verified

March 1, 2006

First QC Date

June 26, 2006

Last Update Submit

June 26, 2006

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (2)

  • Study retention

  • Drug use

Secondary Outcomes (1)

  • Safety

Interventions

LAAM. buprenorphine and methadoneDRUG

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 21 to 55 years
  • diagnosis of opioid dependence by criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
  • evidence of recent opioid use on toxicologic screening

You may not qualify if:

  • serious medical or psychiatric illness requiring long-term medication
  • positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Johnson RE, Chutuape MA, Strain EC, Walsh SL, Stitzer ML, Bigelow GE. A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependence. N Engl J Med. 2000 Nov 2;343(18):1290-7. doi: 10.1056/NEJM200011023431802.

    PMID: 11058673RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Rolley E Johnson, PharmD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 27, 2006

Study Start

January 1, 1996

Study Completion

June 1, 1998

Last Updated

June 27, 2006

Record last verified: 2006-03

Locations

US(1)