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At the 12-month mark, opioid discontinuation occurred in 29% of patients in the intervention cohort compared with only 7% in the usual care group.
Patients with chronic pain due to nonmalignant causes receiving group-based educational intervention, which included group and individual support as well as skill-based learning, were able to significantly reduce patient-reported opioid use compared with patients receiving usual care, according to an article published in The Journal of the American Medical Association (JAMA).1 Despite these findings, the intervention had no effect on the perceived pain interference with daily life activities.
According to an Agency for Healthcare Research and Quality report, opioids may have small beneficial effects for the chronic nonmalignant causes of pain. However, they were not superior to nonopioid therapy and are linked to an increased risk of both short- and long-term harms.2
“Optimal methods for reducing opioid use remain unclear,” wrote Andrea Furlan, MD, PhD, Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada, and colleagues. ”Tapering opioids quickly without providing alternatives for pain management has potential to cause harm, including suicide, or mental health crisis. However, prior studies that used pain self-management, complementary medicine, pharmacological and biomedical intervention, and opioid replacement to reduce chronic opioid use were limited by poor study methodology or lack of evidence of safety.”
A multicenter, randomized clinical trial of patients treated with strong opioids to treat chronic nonmalignant pain enrolled 608 adults from 191 primary care centers in England between May 2017 and January 2019. The follow-up period occurred in March 2020. Opioids included diamorphine, fentanyl, hydromorphone, buprenorphine, dipipanone, morphine, papaveretum, pentazocine, methadone, oxycodone, pethidine, tapentadol, and tramadol. Race and ethnicity data were self-reported and were used to assess the generalizability of results within this patient population.
Patients were randomized to receive either usual care or 3-day group sessions which stressed skill-based learning and education, designed to encourage opioid cessation, along with 1-on-1 support by a nurse and lay person for an additional 12 months. Randomization occurred using a minimization program stratified by location, baseline score for pain intensity, and baseline morphine equivalent dose of opioids. Usual care consisted of My Opioid Manager, a self-help booklet, as well as a relaxation CD.
The primary endpoints were the Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score and the proportion of patients who self-reported opioid discontinuation.
At the 12-month mark, opioid discontinuation occurred in 29% (n = 65/225) of patients in the intervention cohort and only 7% (n = 15/208) in the usual care group (odds ratio [OR], 5.55 [95% confidence interval (CI), 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P < .001).
Serious adverse events were reported in 8% (n = 25/305) of patients receiving the intervention and 5% (n = 16/303) of those in the usual care group. Serious adverse events included gastrointestinal and locomotor musculoskeletal. A total of 4 patients (1%) in the intervention group received additional medical care for opioid withdrawal symptoms, which included fever, pain, small intestinal bleed, hot flushes, shortness of breath, and an overdose suicide attempt.
Investigators noted that limitations included self-reported opioid use, which were not validated with blood or urine samples. Further, patients recruited in the assessment were not blinded and the study coordinators were regularly unblinded by study participants. As participants volunteered to participate, they were therefore more likely to be committed to reduce the use of opioid medications when compared with patients who chose not to participate. Lastly, approximately half (47%) of patients randomized to the intervention cohort fully adhered to the protocol.