Buprenorphine Naltrexone-P1 A-Cocaine
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
1 other identifier
interventional
8
1 country
1
Brief Summary
The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2008
Shorter than P25 for phase_1
1 active site
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
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedJanuary 12, 2017
October 1, 2009
4 months
August 11, 2008
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Opioid Effects of study drug
daily
Secondary Outcomes (1)
Adverse Events
Daily
Study Arms (1)
1
ACTIVE COMPARATOREach subject will receive all 3 doses of suboxone and placebo
Interventions
4/1mg, 8/2mg 16/4mg
Eligibility Criteria
You may qualify if:
- Provide written informed consent
- Be male/female between the ages of 18-55
- Be in good physical and mental health as determined by interview and physical exam
- Have a body mass index between 18 and 30, inclusive
- Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo
- Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone
- Be able to comply with protocol requirements
- If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo
You may not qualify if:
- please contact site for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Drug Dependence Research Center
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 13, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
January 12, 2017
Record last verified: 2009-10