Divided or Single Exposure (DOSE) Study

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jul 12, 2022

Keywords

ClinConnect Summary

The DOSE Study is a clinical trial designed to explore whether taking methadone once a day is just as effective as taking it twice a day for people who have both opioid use disorder (OUD) and chronic pain. Methadone is a medication commonly used to help manage symptoms of OUD and relieve pain. By comparing these two dosing schedules, the study aims to find the best way to help individuals who are facing both challenges.

To participate in this study, you need to be at least 18 years old, have been on a stable dose of methadone for more than 30 days, and report experiencing pain. You should also be comfortable with using a cellular phone provided by the study during part of the trial. If you are pregnant, have a serious medical condition that needs immediate attention, or plan to stop your methadone treatment during the study, you won't be eligible. Participants can expect to attend regular study visits and will receive support throughout the trial. This research could help improve treatment options for people dealing with OUD and chronic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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)