{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,5,17]],"date-time":"2024-05-17T19:40:01Z","timestamp":1715974801227},"reference-count":0,"publisher":"Weston Medical Publishing","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J of Opioid Management"],"abstract":"<jats:p>Objective: To evaluate whether intact or crushed doses of an extended-release formulation of morphine sulfate surrounding an inner core of sequestered naltrexone (MSN) induces signs and symptoms of withdrawal in opioid-dependent patients.&#x0D;\nDesign: Randomized, double-blind, two-way crossover study.&#x0D;\nSetting: Single center.&#x0D;\nPatients: Fourteen patients with chronic moderate-to-severe noncancer pain receiving opioids were enrolled into the study; six completed the maintenance and treatment phases prior to early study discontinuation for issues with manufacturing; eight discontinued: adverse effects (4), noncompliance (1), patient decision (1), study termination (2).&#x0D;\nInterventions: Patients were titrated to a stable dose of MSN (ranging from 30\/1.2 to 100\/4.0 mg of morphine\/naltrexone) that was used in the single-dose crossover evaluation of crushed and intact MSN.&#x0D;\nMain outcome measures: Clinical Opiate Withdrawal Scale (COWS).&#x0D;\nResults: Clinically significant withdrawal (COWS \u2265 13) was observed with rapid onset (\u2265 0.8 hours postdose) in three patients (50 percent) following treatment with crushed MSN at the highest doses administered of \u2265 60\/2.4 mg. Although naltrexone exposure was negligible following exposure to intact MSN, increasing plasma levels of naltrexone and 6-\u03b2-naltrexol were associated with COWS score \u2265 13 in patients who received crushed MSN. COWS \u2265 13 was observed in one patient receiving intact MSN without quantifiable naltrexone concentrations.&#x0D;\nConclusion: Crushing the MSN capsule may precipitate moderate-to-severe signs and symptoms of opioid withdrawal in opioid-dependent individuals. The negligible exposure to naltrexone following exposure to intact MSN supports that intact capsules may be taken safely without precipitating withdrawal in opioid-dependent individuals.<\/jats:p>","DOI":"10.5055\/jom.2013.0155","type":"journal-article","created":{"date-parts":[[2014,3,28]],"date-time":"2014-03-28T23:42:07Z","timestamp":1396050127000},"page":"139-150","source":"Crossref","is-referenced-by-count":12,"title":["A clinical trial to determine if corelease of morphine and naltrexone from crushed extended-release capsules induces withdrawal in opioid-dependent patients: A descriptive analysis of six patients"],"prefix":"10.5055","volume":"9","author":[{"given":"Beatrice","family":"Setnik, PhD","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carl L.","family":"Roland, PharmD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veeraindar","family":"Goli, MD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth","family":"Sommerville, MD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lynn","family":"Webster, MD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"3008","published-online":{"date-parts":[[2013,3,1]]},"container-title":["Journal of Opioid Management"],"original-title":[],"link":[{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/download\/3425\/3721","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/download\/3425\/3721","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,9]],"date-time":"2023-05-09T13:48:46Z","timestamp":1683640126000},"score":1,"resource":{"primary":{"URL":"https:\/\/wmpllc.org\/ojs\/index.php\/jom\/article\/view\/3425"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,3,1]]},"references-count":0,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2013,3,1]]}},"URL":"https:\/\/doi.org\/10.5055\/jom.2013.0155","relation":{},"ISSN":["1551-7489","1551-7489"],"issn-type":[{"value":"1551-7489","type":"electronic"},{"value":"1551-7489","type":"print"}],"subject":[],"published":{"date-parts":[[2013,3,1]]}}}