Opioid Trials: time for A New Approach? Enriched Enrollment Randomized Gradual Withdrawal Designs

References

• Katz N . Methodological issues in clinical trials of opioids for chronic pain. Neurology65(Suppl. 4), S32–S49 (2005).
   PubMedGoogle Scholar
• Nadeau SE , WuJK , LawhernRA. Opioids and chronic pain: an analytic review of the clinical evidence. Front. Pain. Res.2, 721357 (2021).
   Google Scholar
• Cherny N , RipamontiC , PereiraJet al. Strategies to manage the adverse effects of oral morphine: an evidence-based report. J. Clin. Oncol.19, 2542–2554 (2001).
   PubMed Web of Science ®Google Scholar
• Quang-Cantagrel N , WallaceMS , MagnusonSK. Opioid substitution to improve the effectiveness of chronic noncancer pain control: a chart review. Anesth. Analg.90, 933–937 (2000).
   PubMed Web of Science ®Google Scholar
• Banks S , KernsR. Explaining high rates of depression in chronic pain: a diathesis-stress framework. Psychol. Bull.119, 95–110 (1996).
   Web of Science ®Google Scholar
• Hale ME , AhdiehH , MaT , RauckR, Oxymorphone ER Study Group 1. Efficacy and safety of OPANA ER (oxymorphone extended release) for relief of moderate to severe low back pain in opioid-experienced patients: a 12-week, randomized, double-blind, placebo-controlled study. J. Pain8, 175–184 (2007).
   PubMed Web of Science ®Google Scholar
• Breivik H , BorchgrevinkPC , AllenSMet al. Assessment of pain. Br. J. Anaesthesia101, 17–24 (2008).
   PubMed Web of Science ®Google Scholar
• Kim J , LeeKS , KongSWet al. Correlations between electrically quantified pain degree, subjectively assessed visual analogue scale, and the McGill Pain Questionnaire: a pilot study. Ann. Rehabil. Med.38, 665–672 (2014).
   PubMedGoogle Scholar
• Moore RA , WiffenPJ , EcclestonCet al. Systematic review of enriched enrolment, randomised withdrawal trial designs in chronic pain: a new framework for design and reporting. Pain156, 1382–1395 (2015).
   PubMed Web of Science ®Google Scholar
• Meske DS , LawalOD , ElderH , LangbergV , PaillardF , KatzN. Efficacy of opioids versus placebo in chronic pain: a systematic review and meta-analysis of enriched enrollment randomized withdrawal trials. J. Pain Res.11, 923–934 (2018).
   PubMed Web of Science ®Google Scholar
• Gimbel J , SpieringsELH , KatzN , XiangQ , TzanisE , FinnA. Efficacy and tolerability of buccal buprenorphine in opioid-experienced patients with moderate to severe chronic low back pain: results of a Phase III, enriched enrollment, randomized withdrawal study. Pain157(11), 2517–2526 (2016).
   PubMed Web of Science ®Google Scholar
• Kawamata M , IsekiM , KawakamiMet al. Efficacy and safety of controlled-release oxycodone for the management of moderate to severe chronic low back pain in Japan: results of an enriched enrollment randomized withdrawal study followed by an open-label extension study. J. Pain Res.12, 363–375 (2019).
   PubMed Web of Science ®Google Scholar
• Shaheed CA , MaherCG , WilliamsKA , DayR , McLachlanAJ. Efficacy, tolerability, and dose-dependent effects of opioid analgesics for low back pain. A systematic review and meta-analysis. JAMA Intern. Med.176(7), 958–968 (2016).
   PubMed Web of Science ®Google Scholar
• Busse JW , WangL , KamaleldinMet al. Opioids for chronic noncancer pain. A systematic review and meta-analysis. JAMA320, 2448–2460 (2018).
   PubMed Web of Science ®Google Scholar
• Katz N . Enriched enrollment randomized withdrawal trial designs of analgesics. Focus on methodology. Clin. J. Pain25, 797–807 (2009).
   PubMed Web of Science ®Google Scholar
• Kopec JA , AbrahamowiczM , EsdaileJM. Randomized discontinuation trials: utility and efficiency. J. Clin. Epidemiol.46(9), 959–971 (1993).
   PubMed Web of Science ®Google Scholar
• Kim Y . Missing data handling in chronic pain trials. J. Biopharm. Stat.21(2), 311–325 (2011).
   PubMed Web of Science ®Google Scholar
• Schneider LS , TariotPN , DagermanKSet al. Effective of atypical antipshychotic drugs in patients with Alzheimer’s disease. N. Engl. J. Med.355, 1525–1538 (2006).
   PubMed Web of Science ®Google Scholar
• Dehbi H , RoystonP , HackshawA. Life expectancy differences and life expectancy ratio: two measures of treatment effects in randomised trials with non-proportional hazards. BMJ357, j2250 (2017).
   PubMedGoogle Scholar
• Royston P , ParmarMK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med. Res. Methodol.13, 152 (2013).
   PubMed Web of Science ®Google Scholar
• Da Costa BR , PereiraTV , SaadatPet al. Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis. BMJ375, n2321 (2021).
   PubMedGoogle Scholar
• Skelly AC , ChouR , DettoriJRet al. Noninvasive nonpharmacological treatment for chronic pain: a systematic review. Comparative Effectiveness Review No. 209. AHRQ Publication No. 18-EHC013-EF doi:10.23970/AHRQEPCCER209 (2018) (Epub ahead of print).
   Google Scholar
• Skelly AC , ChouR , DettoriJRet al. Noninvasive nonpharmacological treatment for chronic pain: a systematic review update. Comparative Effectiveness Review No. 227. AHRQ Publication No. 20-EHC009. doi:10.23970/AHRQEPCCER227 (2020) (Epub ahead of print).
   Google Scholar
• Park TW , SaitzR , GanoczyD , IlgenMA , BohnertASB. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ350, h2698 (2015).
   PubMed Web of Science ®Google Scholar
• Xu KY , HartzSM , BorodovskyJT , BierutLJ , GruczaRA. Association between benzodiazepine use with or without opioid use and all-cause mortality in the United States, 1999–2015. JAMA Network Open3(12), e2028577 (2020).
   Web of Science ®Google Scholar
• Bohnert ASB , ValensteinM , BairMJet al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA305, 1315–1321 (2011).
   PubMed Web of Science ®Google Scholar
• Gomes T , JuurlinkDN , DhallaIA , Mailis-GagnonA , PatersonJM , MamdaniMM. Trends in opioid use and dosing among socio-economically disadvantaged patients. Open Med.5, 13–22 (2011).
   PubMedGoogle Scholar
• Cowley NJ , OwenA , BionJF. Interpreting arterial blood gas results. BMJ346(f16), 1–7 (2013).
   Google Scholar
• Krebs EE , LorenzKA , BairMJet al. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J. Gen. Intern. Med.24(6), 733–738 (2009).
   PubMed Web of Science ®Google Scholar