Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Study Type

Interventional

Enrollment (Actual)

582

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California
    • Florida
      • Tampa, Florida, United States, 33612
        • Va Medical Center
    • Illinois
      • Hines, Illinois, United States, 60141
        • Va Medical Center
    • New York
      • New York, New York, United States, 10010
        • New York VAMC
    • Washington
      • Seattle, Washington, United States, 98108
        • VA PUget Sound Helath Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Completion of Cooperative Study 1008 A/B

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buprenorphine/Naloxone
Drug: Buprenorphine/naloxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Craving
Retention
Opioid withdrawal
Subjective rating

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Collaborators

New York MDRU

Investigators

  • Study Chair: Paul Casadonte, M.D., New York VAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (Actual)

August 1, 2001

Study Completion (Actual)

September 1, 2001

Study Registration Dates

First Submitted

April 18, 2001

First Submitted That Met QC Criteria

April 17, 2001

First Posted (Estimate)

April 18, 2001

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-5-0013-14
  • Y01-5-0013-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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