At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 27 enrolled
Drug / intervention
oxycodone 15 mg +2 moredrug
Likely dose
Oxycodone 15 mg or 30 mg once daily orallyAI-extracted
Key inclusion· 5
- ✓Current opioid abuse (but not dependence)
- ✓History of opioid use for medical or recreational purposes at least twice in lifetime without serious adverse effects
- ✓Good physical health and normal body weight
- ✓Women with regular menstrual cycles of 24-35 days
Key exclusion· 13
- ✕Current or lifetime opioid dependence
- ✕On parole or probation, or recently convicted of a violent crime
- ✕History of significant violent behavior
- ✕Current Axis I psychopathology or significant Axis II disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prescription Opioid Effects in Drug and Non-drug Abusers - 1
In Brief
A Phase 2 clinical trial evaluating oxycodone 15 mg, oxycodone 30 mg, and 1 other intervention for Opioid-Related Disorders and Substance-Related Disorders. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
First PostedSep 2005
Primary CompletionJun 2009
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartJun 1, 2004
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago
Interventions
oxycodone 15 mgdrug
15 mg/70 kg oxycodone administered once per day, orally.
oxycodone 30 mgdrug
30 mg/70 kg oxycodone administered once per day, orally.
Placebo 0 mgdrug
0 mg placebo dose administered once a day, orally.