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Conditioned open-label placebos (COLPs) have been effective for reducing the dose of active medication required for a clinical response across a wide range of medical conditions. We hypothesise that the addition of COLPs to standard multimodal analgesia will be associated with reduced baseline opioid consumption by 5\u2009days after surgery in comparison to standard multimodal analgesia alone in patients with head and neck cancer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>This randomised controlled trial will evaluate the use of COLP for adjunctive pain management in patients with head and neck cancer. Participants will be randomised with 1:1 allocation to either the treatment as usual or COLP group. All participants will receive standard multimodal analgesia, including opioids. The COLP group will additionally receive conditioning (ie, exposure to a clove oil scent) paired with active and placebo opioids for 5\u2009days. Participants will complete surveys on pain, opioid consumption and depression symptoms through 6\u2009months after surgery. Average change in baseline opioid consumption by postoperative day 5 and average pain levels and opioid consumption through 6\u2009months will be compared between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>There remains a demand for more effective and safer strategies for postoperative pain management in patients with head and neck cancer as chronic opioid dependence has been associated with decreased survival in this patient population. Results from this study may lay the groundwork for further investigation of COLPs as a strategy for adjunctive pain management in patients with head and neck cancer. This clinical trial has been approved by the Johns Hopkins University Institutional Review Board (IRB00276225) and is registered on the National Institutes of Health Clinical Trials Database.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04973748\">NCT04973748<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2022-069785","type":"journal-article","created":{"date-parts":[[2023,7,7]],"date-time":"2023-07-07T09:31:15Z","timestamp":1688722275000},"page":"e069785","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Study protocol: randomised controlled trial of conditioned open-label placebo (COLP) for perioperative pain management in patients with head and neck cancer"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct04973748","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1974-1880","authenticated-orcid":false,"given":"Danielle R","family":"Trakimas","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6503-4709","authenticated-orcid":false,"given":"Luana","family":"Colloca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carole","family":"Fakhry","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marietta","family":"Tan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zubair","family":"Khan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter S","family":"Vosler","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,7,7]]},"reference":[{"key":"2023080101152564000_13.7.e069785.1"},{"key":"2023080101152564000_13.7.e069785.2","doi-asserted-by":"crossref","first-page":"996","DOI":"10.1016\/j.jamcollsurg.2017.10.012","article-title":"Guideline for discharge opioid prescriptions after inpatient general surgical procedures","volume":"226","author":"Hill","year":"2018","journal-title":"J Am Coll Surg"},{"key":"2023080101152564000_13.7.e069785.3","doi-asserted-by":"crossref","first-page":"659","DOI":"10.1002\/lary.28101","article-title":"Postoperative opioid-prescribing practices in otolaryngology: a multiphasic study","volume":"130","author":"Dang","year":"2020","journal-title":"Laryngoscope"},{"doi-asserted-by":"publisher","key":"2023080101152564000_13.7.e069785.4","DOI":"10.1002\/lary.23886"},{"doi-asserted-by":"publisher","key":"2023080101152564000_13.7.e069785.5","DOI":"10.1176\/appi.psy.48.2.142"},{"key":"2023080101152564000_13.7.e069785.6","first-page":"397","article-title":"A review of depression in the head and neck cancer patient","volume":"7","author":"Lydiatt","year":"2009","journal-title":"Clin Adv Hematol Oncol"},{"doi-asserted-by":"publisher","key":"2023080101152564000_13.7.e069785.7","DOI":"10.1097\/PSY.0b013e3181cbd38b"},{"doi-asserted-by":"crossref","unstructured":"Morales-Quezada L , Mesia-Toledo I , Estudillo-Guerra A , et al . 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