Divided or Single Exposure (DOSE) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2028-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid Use Disorder Chronic Pain Methadone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Treatment as Usual (TAU)

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

Group Type ACTIVE_COMPARATOR

Methadone (100% dose)

Intervention Type DRUG

Methadone for the treatment of opioid use disorder

Split-dosing

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

Group Type EXPERIMENTAL

Methadone (50% dose)

Intervention Type DRUG

Methadone for the treatment of opioid use disorder

Interventions

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Methadone (100% dose)

Methadone for the treatment of opioid use disorder

Intervention Type DRUG

Methadone (50% dose)

Methadone for the treatment of opioid use disorder

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No