Divided or Single Exposure (DOSE) Study

Description

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.

Conditions

Opioid Use Disorder, Chronic Pain, Methadone

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Study Overview

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Study Details

Study overview

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.

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

Divided or Single Exposure (DOSE) Study

Condition
Opioid Use Disorder
Intervention / Treatment

-

Contacts and Locations

Baltimore

Addiction Treatment Services (ATS), Baltimore, Maryland, United States, 21224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Kelly E Dunn, PhD, M.B.A., PRINCIPAL_INVESTIGATOR, University of Maryland

Denis Antoine, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2028-10