Trial of Buprenorphine/Naloxone for Opiate Dependence - 2 | NCT00000353

Studies
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2

NCT00000353

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

Phase

Phase 2

Conditions

Opioid-Related Disorders
Substance-Related Disorders

Interventions

Buprenorphine/naloxone

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

ID	Type	Description	Link
Y01-3-0012-2

Status Module

Record Verification Date

Dec 2002

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1996

Primary Completion Date

Sep 1997Actual

Completion Date

Oct 1997Actual

First Submitted Date

Sep 20, 1999

First Submission Date that Met QC Criteria

Sep 20, 1999

First Posted Date

Sep 21, 1999Estimated

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

Jan 17, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Name	Class
University of Pennsylvania	OTHER

Description Module

Brief Summary

The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate dependence treatment.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Buprenorphine/naloxone	Drug

Eligibility Module

Eligibility Criteria

Please contact site for information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

57 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles O'Brien, M.D., Ph.D.	PDVAMC Treatment Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104 6178	United States

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders
D019966	Substance-Related Disorders

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069479	Buprenorphine, Naloxone Drug Combination

Ancestor Terms

ID	Term
D002047	Buprenorphine
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided