Conditions: Opioid Abuse
Keywords: Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 49
Healthy volunteers: yes

Brief summary:
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.

Detailed description:
In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.

Arms:
arm 1: 8x oxycodone/niacin 5/0mg tablets arm 2: 8x oxycodone/niacin 10/0mg tablets arm 3: 8x oxycodone/niacin 5/30mg tablets arm 4: 8x oxycodone/niacin 10/60mg tablets arm 5: Placebo

Interventions: intervention 1: 40/0mg taken first intervention 2: 80/0mg taken first intervention 3: 40/240mg taken first intervention 4: 80/480mg taken first intervention 5: 0/0mg taken first
Intervention descriptions: intervention 1: 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses intervention 2: 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses intervention 3: 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses intervention 4: 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses intervention 5: Placebo All arms taken with a 48 hour washout between doses

Protocol document: