A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
NCT ID: NCT02218021
Last Updated: 2014-12-02
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
59 participants
INTERVENTIONAL
2014-08-31
2014-11-30
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
DOUBLE
Study Groups
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Samidorphan Dose 1
Samidorphan
Samidorphan Dose 2
Samidorphan
Samidorphan Dose 3
Samidorphan
Placebo
Placebo
Oxycodone Dose 1
Oxycodone
Oxycodone Dose 2
Oxycodone
Interventions
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Samidorphan
Placebo
Oxycodone
Eligibility Criteria
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Inclusion Criteria
* Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
* Recreational opioid use experience for non-therapeutic purposes (at \>/= 10 times in lifetime and \>/= 1 in previous 3 months
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply
Exclusion Criteria
* History of or current infection with hepatitis B virus, hepatitis C virus or HIV
* Current or history of any clinically significant medical or psychiatric condition
* Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
* Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)
* Additional criteria may apply
18 Years
55 Years
ALL
Yes
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sanjeev Pathak, MD
Role: STUDY_DIRECTOR
Alkermes, Inc.
Locations
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Alkermes Investigational Site
Overland Park, Kansas, United States
Countries
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Other Identifiers
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ALK33-012
Identifier Type: -
Identifier Source: org_study_id