Divided or Single Exposure (DOSE) Study

Официальное название

Divided or Single Exposure (DOSE) Study: Randomized Controlled Trial for Pain in Persons Receiving Methadone Treatment

Обзор

This study will evaluate whether once versus twice daily dosing of methadone will be an effective method for managing comorbid pain and opioid use disorder.

Подробное описание

This study follows a successfully completed project (NCT03254043) to now pursue the investigators overarching goal of optimizing methadone dosing as a method for managing comorbid chronic pain and opioid use disorder (OUD) among persons receiving methadone for the treatment of OUD. Up to 62% of persons maintained on methadone for OUD experience clinically significant pain, versus 31% in the general population. Pain in methadone-maintained persons (MMP) is associated with poor OUD treatment outcomes and severe distress. No effective treatment for comorbid pain and OUD currently exists; though preclinical and human data suggest divided methadone dosing may be a more optimal strategy for managing pain than once daily dosing, this has never been empirically examined. This study will evaluate an intervention for comorbid chronic pain among MMP using a Phase II double-blind, randomized, placebo-controlled comparison of treatment as usual (TAU) versus split daily methadone dosing for 12-weeks. Methadone will be remotely managed via an electronic pillbox. Outcomes will include weekly assessments of pain and OUD outcomes, ecological momentary assessment of pain before and after dosing, and point-prevalence measures of laboratory-induced pain to explore mechanism of effects. If effective, this approach could transform the care of MMP with pain because it would be feasible to implement within the operational structure of a methadone clinic and would impose low provider burden. Results could provide a high magnitude treatment for the substantial number of MMP who experience daily pain with no reliable form of treatment.

Вмешательства

• Препарат Methadone (100% dose)
  Methadone for the treatment of opioid use disorder
• Препарат Methadone (50% dose)
  Methadone for the treatment of opioid use disorder

Первичные конечные точки

• Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale [Срок оценки: Week 1 up to week 12]

Вторичные конечные точки (3)

• Change in Pain Tolerance Latency [Срок оценки: Weeks 1, 6, and 12]
• Change in Pain Interference- past 7 days as assessed by Pain-related Disability Scale Total Score [Срок оценки: Week 1 up to 12]
• Change in Opioid Withdrawal Severity- past 24 hours as assessed by the Subjective Opioid Withdrawal Scale [Срок оценки: Week 1 up to 12]

Критерии участия

Критерии включения

• Aged 18 years of age or older
• Currently receiving methadone for treatment of OUD for >90 days and have been consuming the same dose for >30 days
• Have previously received a take-home dose of methadone as part of routine care
• Willing to comply with study schedule
• Report pain (specific definition blinded)
• Have a cellular phone or be willing to carry phone provided by the study during one phase of the study

Критерии исключения

• Pregnant
• Presence of acute medical problem that requires immediate and intense medical management
• Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits
• Plans to leave methadone treatment during the study period
• Maintained on a dose of methadone that would prevent effective splitting of doses
• Currently receiving split doses of methadone
• Currently receiving treatment for pain for which the split-dosing of methadone is judged by medical staff to be contraindicated or otherwise interfere with study conduct or integrity
• Does not meet criteria for mild-severe disability (definition blinded)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Addiction Treatment Services (ATS) — Baltimore

Публикации

• McKendrick G, Davis W, Sklar M, Brown N, Pattillo E, Finan PH, Antoine D, Walters V, Dunn KE. The IMPOWR Network Divided or Single Exposure Study (DOSE) Protocol: A Randomized Controlled Comparison of Once Versus Split Dosing of Methadone for the Treatment of Comorbid Chronic Pain and Opioid Use Disorder. Subst Use Addctn J. 2025 Jan;46(1):197-200. doi: 10.1177/29767342241239167. Epub 2024 Mar 25. PMID 38528704

Идентификаторы

NCT: NCT05459402 · IRB00318642 · 1R01DA056045 · 1R01DA056045-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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