- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000353
Trial of Buprenorphine/Naloxone for Opiate Dependence - 2
January 17, 2017 updated by: National Institute on Drug Abuse (NIDA)
Efficacy/Safety Trial of Buprenorphine/Nx for Opiate Dependence
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
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
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104 6178
- University of Pennsylvania
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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
19 years to 57 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Please contact site for information.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
October 1, 1996
Primary Completion (Actual)
September 1, 1997
Study Completion (Actual)
October 1, 1997
Study Registration Dates
First Submitted
September 20, 1999
First Submitted That Met QC Criteria
September 20, 1999
First Posted (Estimate)
September 21, 1999
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 17, 2017
Last Verified
December 1, 2002
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Disease
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
- Naloxone
- Buprenorphine, Naloxone Drug Combination
Other Study ID Numbers
- NIDA-3-0012-2
- Y01-3-0012-2
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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