- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000344
Buprenorphine/Naloxone for Treatment of Opiate Dependence - 9
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
Trial of Buprenorphine/Naloxone for Treatment of 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
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
40
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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California
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Los Angeles, California, United States, 90025
- Friends Research Institute
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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
21 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.
Exclusion Criteria:
Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.
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: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Completion (Actual)
August 1, 2000
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 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
August 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- 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-3-0010-9
- Y01-3-0010-9
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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University of ArkansasNational Institute on Drug Abuse (NIDA)CompletedOpioid Dependence | Opioid Withdrawal | Opioid DetoxificationUnited States
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Vanderbilt University Medical CenterCompletedOpioid Use | Opioid-use DisorderUnited States
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University of PennsylvaniaCompletedSurgery | Opioid Use | Opioid Misuse | Prescription Opioid MisuseUnited States
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The University of Texas Health Science Center at...TerminatedOpioid Dependence | Opioid Abuse, UnspecifiedUnited States
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University of MinnesotaRecruitingOpioid Dependence | Opioid Abuse | Opioid-use DisorderUnited States
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Brigham and Women's HospitalOhio State UniversityActive, not recruitingOpioid Dependence | Opioid Use | Opioid-use DisorderUnited States
Clinical Trials on Buprenorphine/naloxone
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Duke UniversityNational Institute on Drug Abuse (NIDA); The Emmes Company, LLCCompletedOpioid Use DisorderUnited States
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Montefiore Medical CenterRecruiting
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Yale UniversityNational Institute on Drug Abuse (NIDA)CompletedOpiate DependenceUnited States
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INSYS Therapeutics IncCompletedStudy of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy VolunteersOpiate DependenceUnited States
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Indivior Inc.Completed
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Wayne State UniversityCompletedEffects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence (BOS)Heroin Dependence | Opioid Use DisorderUnited States
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National Institute on Drug Abuse (NIDA)Cincinnati MDRUCompletedSubstance-Related Disorders | Opioid-Related DisordersUnited States
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National Institute on Drug Abuse (NIDA)CompletedOpioid-Related DisordersUnited States
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National Institute on Drug Abuse (NIDA)New York MDRUCompletedOpioid-Related Disorders | Heroin DependenceUnited States