BridgeMD
New treatment option for Opioid Use Disorder
Official title Divided or Single Exposure (DOSE) Study
ClinicalTrials.gov ID: NCT05459402
What this study is testing
What is Methadone (100% dose)?
Methadone (100% dose) is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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)
You likely can't join 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
See the full 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)
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.