NCT00000353

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.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1996

Shorter than P25 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

October 1, 1996

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1997

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1997

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

January 18, 2017

Status Verified

December 1, 2002

Enrollment Period

11 months

First QC Date

September 20, 1999

Last Update Submit

January 17, 2017

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

opiate dependence

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age19 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Please contact site for information.

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Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104 6178, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Charles O'Brien, M.D., Ph.D.

    PDVAMC Treatment Research Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

October 1, 1996

Primary Completion

September 1, 1997

Study Completion

October 1, 1997

Last Updated

January 18, 2017

Record last verified: 2002-12

Locations

US(1)