Divided or Single Exposure (DOSE) Study

NCT05459402 | Recruiting Phase 2

• 3 other identifiers: IRB003186421R01DA0560451R01DA056045-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Change in worst pain rating- past 24 hour as assessed by the Brief Pain Inventory scale

  Using the Brief Pain Inventory rating of "Worst Pain" in the past 24 hours, rated on a scale of 1-10, collected once weekly during weeks 1 through 12 of the intervention.

  Week 1 up to week 12

Secondary Outcomes (3)

• Change in Pain Tolerance Latency

  Weeks 1, 6, and 12

• Change in Pain Interference- past 7 days as assessed by Pain-related Disability Scale Total Score

  Week 1 up to 12

• Change in Opioid Withdrawal Severity- past 24 hours as assessed by the Subjective Opioid Withdrawal Scale

  Week 1 up to 12

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants in treatment as usual group will receive 100% active methadone in AM + placebo in PM.

Drug: Methadone (100% dose)

Split-dosing

EXPERIMENTAL

Participants in split dosing group will receive 50% active methadone + placebo twice daily.

Drug: Methadone (50% dose)

Interventions

Methadone (50% dose) DRUG

Methadone for the treatment of opioid use disorder

Split-dosing

Methadone (100% dose) DRUG

Methadone for the treatment of opioid use disorder

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Addiction Treatment Services (ATS)

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Kelly E Dunn, PhD, M.B.A.

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Denis Antoine, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly E Dunn, PhD, M.B.A.

CONTACT

802-922-1682; kelly.dunn@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be done to prevent biasing participants or staff about the suspected group assignments. Blinded medication doses will be over-encapsulated by the research pharmacy, which will manage all randomization and blinding. Participants will be informed as part of their enrollment that no increases in methadone dosing will be permitted during the active intervention period; dose decreases will be permitted if determined necessary for safety purposes by medical providers and any changes will be implemented in a double-blinded manner by the study pharmacist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled for a 14-week Phase II between-group intervention period followed by a 6-month follow-up period with once monthly visits. All participants will be transitioned from liquid to tablet methadone within a 1 to 2-week period before being randomized to treatment as usual versus split daily methadone dosing for a 12-week period. Participants will complete monthly follow-up visits during months 4 - 9.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: February 21, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)