NCT00015340

Brief Summary

The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
582

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 1999

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

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

August 1, 1999

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 18, 2001

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2001

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

April 18, 2001

Last Update Submit

January 11, 2017

Conditions

Opioid DependenceSubstance-Related Disorders

Keywords

Opioid Dependence

Outcome Measures

Primary Outcomes (4)

  • Craving

  • Retention

  • Opioid withdrawal

  • Subjective rating

Study Arms (1)

Buprenorphine/Naloxone

EXPERIMENTAL
Drug: Buprenorphine/naloxone

Interventions

Buprenorphine/naloxoneDRUG
Buprenorphine/Naloxone

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Completion of Cooperative Study 1008 A/B

You may not qualify if:

  • \- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California

Los Angeles, California, 90095, United States

Location

VA Medical Center

Tampa, Florida, 33612, United States

Location

VA Medical Center

Hines, Illinois, 60141, United States

Location

New York VAMC

New York, New York, 10010, United States

Location

VA PUget Sound Helath Care System

Seattle, Washington, 98108, 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

  • Paul Casadonte, M.D.

    New York VAMC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

April 18, 2001

First Posted

April 18, 2001

Study Start

August 1, 1999

Primary Completion

August 1, 2001

Study Completion

September 1, 2001

Last Updated

January 12, 2017

Record last verified: 2016-08

Locations

US(5)