A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers
NCT ID: NCT01746901
Last Updated: 2018-10-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
81 participants
INTERVENTIONAL
2013-02-28
2013-08-09
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
OTHER
DOUBLE
Study Groups
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Treatment A
Placebo
Placebo solution + Placebo ALO-02 (intact)
Treatment B
intact ALO-02 60 mg/7.2 mg
Placebo solution + ALO-02 60 mg/7.2 mg (intact)
Treatment C
crushed ALO-02 60 mg/7.2 mg
crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)
Treatment D
crushed oxycodone IR 60 mg
crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)
Treatment E
crushed ALO-02 40 mg/4.8 mg
crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)
Treatment F
crushed oxycodone IR 40 mg
crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)
Interventions
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Placebo
Placebo solution + Placebo ALO-02 (intact)
intact ALO-02 60 mg/7.2 mg
Placebo solution + ALO-02 60 mg/7.2 mg (intact)
crushed ALO-02 60 mg/7.2 mg
crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)
crushed oxycodone IR 60 mg
crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)
crushed ALO-02 40 mg/4.8 mg
crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)
crushed oxycodone IR 40 mg
crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)
Eligibility Criteria
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Inclusion Criteria
* Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year before Screening Visit, and at least once in 8 weeks before the Screening Visit.
Exclusion Criteria
* Subject has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorder.
* History of sleep apnea.
* Positive urine drug screen (UDS) for other that marijuana.
* Positive for Hepatitis B or C and HIV on Screening.
18 Years
55 Years
ALL
Yes
Sponsors
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Syneos Health
OTHER
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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INC Research Toronto, Inc.
Toronto, Ontario, Canada
Countries
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Related Links
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Other Identifiers
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B4531008
Identifier Type: -
Identifier Source: org_study_id
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