Opioid use following the introduction of an extended-release oxycodone formulation with tamper-resistant properties: Prospective historical chart review in methadone-maintained patients.

Objective: Emerging data are demonstrating that tamper-resistant opioids may play an important role in changing prescription opioid abuse behaviors. This study was a chart review to examine if the reformulation of OxyContin® into a version with tamper-resistant properties (OxyNEO®) had an impact on oxycodone-positive urine drug screens (UDSs) in opioid-dependent patients receiving methadone maintenance therapy (MMT).

Design: The historical element of this study examined 250 eligible charts from patients on MMT who had data during the time periods when only OxyContin was available (baseline period), during the transition to OxyNEO, and when only OxyNEO was available.

Controlled-release oxycodone and naloxone in the treatment of chronic low back pain: a placebo-controlled, randomized study.

Background: For Canadian regulatory purposes, an analgesic study was required to complement previously completed, pivotal studies on bowel effects and analgesia associated with controlled-release (CR) oxycodone⁄CR naloxone.

Objectives: To compare the analgesic efficacy and safety of CR oxycodone⁄CR naloxone versus placebo in patients with chronic low back pain.

Methods: Patients requiring opioid therapy underwent a two- to seven-day opioid washout before being randomly assigned to receive either 10 mg⁄5 mg CR oxycodone⁄CR naloxone or placebo every 12 h, titrated weekly according to efficacy and tolerability to 20 mg⁄10 mg, 30 mg⁄15 mg or 40 mg⁄20 mg every 12 h.

The Pain and Sleep Questionnaire three-item index (PSQ-3): a reliable and valid measure of the impact of pain on sleep in chronic nonmalignant pain of various etiologies.

Background: Sleep disturbance is among the more common complaints reported by chronic pain patients. Because pain-related sleep disturbance may serve as a marker for the assessment of responses to treatment for chronic pain, inclusion of a measure designed to assess the impact of pain on sleep in clinical trial protocols is important, if not necessary. Measures typically used for this purpose lack scales specifically designed for the assessment of the impact of pain on sleep or are based on a single item.

Buprenorphine transdermal system in adults with chronic low back pain: a randomized, double-blind, placebo-controlled crossover study, followed by an open-label extension phase.

Background: Buprenorphine is a mixed-activity, partial mu-opioid agonist. Its lipid solubility makes it well suited for transdermal administration.

Objective: This study assessed the efficacy and safety profile of a 7-day buprenorphine transdermal system (BTDS) in adult (age >18 years) patients with moderate to severe chronic low back pain previously treated with > or =1 tablet daily of an opioid analgesic.

Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.

Objective: The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks.

Methods: Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS.