At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 45 enrolled
Drug / intervention
ALO-02 weight-matched placebo +3 moredrug
Likely dose
crushed ALO-02 30 mg/3.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended Release Capsules) Compared To Oxycodone Immediate Release, And Placebo When Administered Intranasally To Non-dependent, Recreational Opioid Users.
In Brief
A Phase 1 clinical trial evaluating ALO-02 weight-matched placebo, crushed ALO-02 30 mg/3.6 mg, and 2 other interventions for Healthy. Completed, enrolled 45 participants across 1 site.
Detailed Summary
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
CollaboratorsSyneos Health
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionJul 2013
TodayJul 2026
First PostedJan 24, 2013
Enrollment StartFeb 1, 2013
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.4 years ago
Interventions
ALO-02 weight-matched placebodrug
crushed sugar spheres (powder) x 1 dose
crushed ALO-02 30 mg/3.6 mgdrug
crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
oxycodone weight-matched placebodrug
crushed lactose tablets (powder) x 1 dose
crushed oxycodone IR 30 mgdrug
Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose