Conditions: Pain
Keywords: ATC, Opioid, withdrawal, switch
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 39
Healthy volunteers: no

Brief summary:
The primary aim of this study is to determine if chronic pain subjects on around-the-clock opioids who are receiving 100 to 220 mg oral morphine sulfate equivalent (MSE) can be safely transitioned on to buprenorphine hydrochloride (HCl) buccal film at 50% of their MSE dose without inducing opioid withdrawal or reversing analgesic effects.

Detailed description:

Arms:
arm 1: Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period arm 2: Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo film + over-encapsulated ATC opioid (morphine sulfate or oxycodone) at 50% MSE daily dose in the alternate period

Interventions: intervention 1: Buprenorphine intervention 2: Placebo film intervention 3: Oxycodone intervention 4: Morphine sulfate intervention 5: Placebo capsule
Intervention descriptions: intervention 1: None intervention 2: Matching placebo buccal film intervention 3: Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets intervention 4: Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets intervention 5: Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets

Protocol document: