Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
8 participants
INTERVENTIONAL
2008-08-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
Each subject will receive all 3 doses of suboxone and placebo
Suboxone
4/1mg, 8/2mg 16/4mg
Interventions
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Suboxone
4/1mg, 8/2mg 16/4mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Responsible Party
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NIDA
Locations
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Drug Dependence Research Center
San Francisco, California, United States
Countries
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Other Identifiers
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N01DA-6-8867
Identifier Type: -
Identifier Source: org_study_id
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