Back to resultsOpioid Maintenance Medications Comparison Study
Primary Purpose
Opioid Dependence
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LAAM. buprenorphine and methadone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence
Eligibility Criteria
Inclusion 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 Exclusion serious medical or psychiatric illness requiring long-term medication positive pregnancy test
Sites / Locations
- Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus
Outcomes
Primary Outcome Measures
Study retention
Drug use
Secondary Outcome Measures
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00344812
Brief Title
Opioid Maintenance Medications Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
LAAM. buprenorphine and methadone
Primary Outcome Measure Information:
Title
Study retention
Title
Drug use
Secondary Outcome Measure Information:
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
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
Exclusion
serious medical or psychiatric illness requiring long-term medication
positive pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolley E Johnson, PharmD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11058673
Citation
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.
Results Reference
result
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Opioid Maintenance Medications Comparison Study
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