A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users
NCT ID: NCT01825447
Last Updated: 2013-10-08
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
89 participants
INTERVENTIONAL
2013-07-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment A
Placebo
0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
Treatment B
Oxycodone + Naltrexone
Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
Treatment C
Oxycodone
Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.
Interventions
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Placebo
0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
Oxycodone + Naltrexone
Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
Oxycodone
Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.
Eligibility Criteria
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Inclusion Criteria
* Non-dependent, recreational opioid users
* Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).
Exclusion Criteria
* Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
* History of sleep apnea.
18 Years
55 Years
ALL
Yes
Sponsors
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Lifetree Clinical Research Center, Salt Lake City, Utah
UNKNOWN
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Salt Lake City, Utah, United States
Countries
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Related Links
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Other Identifiers
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B4981002
Identifier Type: -
Identifier Source: org_study_id