Divided or Single Exposure (DOSE) Study

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459402
• Other study ID #: IRB00318642
• Secondary ID: 1R01DA0560451R01
• Status: Recruiting
• Phase: Phase 2
• Start date: February 21, 2023
• Est. completion date: October 2028

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Kelly E Dunn, PhD, M.B.A.
• Phone: 410-550-2254
• Email: kdunn9[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Methadone
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Addiction Treatment Services (ATS)	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Pain Tolerance Latency	Time in seconds (0-300) to removal of hand from cold pressor measure of laboratory-induced pain, collected point-prevalence during weeks 1, 6, and 12 of the intervention.	Weeks 1, 6, and 12
Secondary	Change in Pain Interference- past 7 days as assessed by Pain-related Disability Scale Total Score	Past 7 day Pain-related Disability Scale Total Score (range 0-70), collected once weekly during weeks 1 through 12 of the intervention.	Week 1 up to 12
Secondary	Change in Opioid Withdrawal Severity- past 24 hours as assessed by the Subjective Opioid Withdrawal Scale	Past 24 hour total score (range 0-64) for the Subjective Opioid Withdrawal Scale (SOWS), collected once weekly during weeks 1 through 12 of the intervention.	Week 1 up to 12