Conditions: Healthy
Keywords: Relative abuse potential study; oxycodone; nalteone; Opioid-related disorders; drug abusers Chronic pain
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 81
Healthy volunteers: yes

Brief summary:
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused.

Detailed description:
Abuse Liability Study

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: Placebo intervention 2: intact ALO-02 60 mg/7.2 mg intervention 3: crushed ALO-02 60 mg/7.2 mg intervention 4: crushed oxycodone IR 60 mg intervention 5: crushed ALO-02 40 mg/4.8 mg intervention 6: crushed oxycodone IR 40 mg
Intervention descriptions: intervention 1: Placebo solution + Placebo ALO-02 (intact) intervention 2: Placebo solution + ALO-02 60 mg/7.2 mg (intact) intervention 3: crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact) intervention 4: crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact) intervention 5: crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact) intervention 6: crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)

Protocol document: