Opioid Maintenance Medications Comparison Study | NCT00344812

Studies
Opioid Maintenance Medications Comparison Study

NCT00344812

Sponsor

Johns Hopkins University

Status

Completed

Last Update Posted

Jun 27, 2006Estimated

Enrollment

220

Phase

Phase 2

Conditions

Opioid Dependence

Interventions

LAAM. buprenorphine and methadone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 1996

Primary Completion Date

Not provided

Completion Date

Jun 1998

First Submitted Date

Jun 26, 2006

First Submission Date that Met QC Criteria

Jun 26, 2006

First Posted Date

Jun 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2006

Last Update Posted Date

Jun 27, 2006Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220

Name	Type	Description	Arm Group Labels	Other Names
LAAM. buprenorphine and methadone	Drug

Measure	Description	Time Frame
Safety

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rolley E Johnson, PharmD	Johns Hopkins University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Behavioral Pharmacology Research Unit; Johns Hopkins Bayview Campus		Baltimore	Maryland	21224	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11058673	Result	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.

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D007659	Ketones
D009930	Organic Chemicals