Journal of opioid management
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Randomized Controlled Trial Multicenter Study Comparative Study
A Phase II, multicenter, randomized, double-blind, placebo-controlled crossover study of CJC-1008--a long-acting, parenteral opioid analgesic--in the treatment of postherpetic neuralgia.
CJC-1008 is a chemical modification of the opioid peptide dynorphin A (1-13) (Dyn A) that promotes dynorphin's covalent attachment to human serum albumin in vivo after administration, thus prolonging its duration of action. The primary objective of this study was to evaluate the preliminary efficacy and safety of CJC-1008 as compared with placebo in patients with postherpetic neuralgia (PHN). ⋯ This study provides evidence of a greater analgesic effect when using CJC-1008 compared to placebo in patients with PHN. However, the effect only lasted through eight hours postdose and diminished by 24 hours. This study provides evidence of a peripheral action of dynorphin, since CJC-1008 does not cross the blood-brain barrier.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
The ACTION study: a randomized, open-label, multicenter trial comparing once-a-day extended-release morphine sulfate capsules (AVINZA) to twice-a-day controlled-release oxycodone hydrochloride tablets (OxyContin) for the treatment of chronic, moderate to severe low back pain.
This large, open-label, randomized, parallel-group, multicenter study compared two oral sustained-release opioids (SROs)--AVINZA (A-MQD), morphine sulfate extended-release capsules given once a day, and OxyContin (O-ER), oxycodone modified-release tablets given twice a day--in SRO-naive subjects ages 30 to 70 with chronic, moderate to severe low back pain. Of the 392 subjects enrolled and randomized, 266 (132 in the A-MQD group and 134 in the O-ER group) completed the opioid dose titration phase and entered an eight-week evaluation phase. During the evaluation phase, A-MQD achieved significantly better pain control than O-ER, as demonstrated by a greater decrease from baseline in pain scores obtained four times daily during weeks one, four, and eight (p = 0.002). ⋯ The incidence and severity of elicited opioid side effects were similar in the two groups. This trial demonstrated that once-daily A-MQD provides consistent around-the-clock pain relief in patients with low back pain. In patients who completed opioid dose titration, A-MQD was significantly better than O-ER for reducing pain and improving sleep, while requiring a lower daily opioid dose.
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Multicenter Study Comparative Study Clinical Trial
Adverse effects and cognitive function among primary care patients taking opioids for chronic nonmalignant pain.
Chronic opioid therapy is commonly prescribed for chronic nonmalignant pain. Few published data describe the adverse effects experienced by patients with chronic nonmalignant pain being treated by primary care physicians. A prevalence study was conducted on a sample of 1,009 patients (889 receiving chronic opioids) being treated by 235 primary care physicians. ⋯ A regression model suggests that psychological measures and pain severity are more predictive of decrements in cognitive function than specific opioid preparations or daily opioid dose. Physicians should closely monitor patients for adverse effects and adequacy of pain control when using chronic opioid therapy for chronic pain treatment. Psychological health, an important predictor of cognitive dysfunction, is a particularly important measure to actively monitor and manage.