Status:
COMPLETED
A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Lifetree Clinical Research Center, Salt Lake City, Utah
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getti...
Eligibility Criteria
Inclusion
- Healthy subjects
- 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
- Diagnosis of substance and/or alcohol dependence
- Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
- History of sleep apnea.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01825447
Start Date
July 1 2013
End Date
September 1 2013
Last Update
October 8 2013
Active Locations (1)
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1
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84106