RECRUITING

Divided or Single Exposure (DOSE) Study

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Conditions

Opioid Use DisorderChronic PainMethadone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-02-21
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05459402

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18 years of age or older
  2. * Currently receiving methadone for treatment of OUD for \>90 days and have been consuming the same dose for \>30 days
  3. * Have previously received a take-home dose of methadone as part of routine care
  4. * Willing to comply with study schedule
  5. * Report pain (specific definition blinded)
  6. * Have a cellular phone or be willing to carry phone provided by the study during one phase of the study
  1. * Pregnant
  2. * Presence of acute medical problem that requires immediate and intense medical management
  3. * Presence of a serious and unstable mental illness that interferes with provision of voluntary informed consent and/or adherence to study visits
  4. * Plans to leave methadone treatment during the study period
  5. * Maintained on a dose of methadone that would prevent effective splitting of doses
  6. * Currently receiving split doses of methadone
  7. * 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
  8. * Does not meet criteria for mild-severe disability (definition blinded)

Contacts and Locations

Study Contact

Kelly E Dunn, PhD, M.B.A.
CONTACT
802-922-1682
kelly.dunn@som.umaryland.edu

Principal Investigator

Kelly E Dunn, PhD, M.B.A.
PRINCIPAL_INVESTIGATOR
University of Maryland
Denis Antoine, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21
Study Completion Date2028-10

Study Record Updates

Study Start Date2023-02-21
Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Chronic Pain
  • Methadone