BridgeMD
New treatment option for Opioid Use Disorder (OUD)
Official title MethaLoad Dose-Finding Study
ClinicalTrials.gov ID: NCT06877858
What this study is testing
What is Methadone hydrochloride?
Methadone hydrochloride is an investigational medicine, being studied as a potential treatment for opioid use disorder (oud).
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
- The goal of this study is to develop a loading dose approach to starting methadone to treat opioid use disorder with fentanyl use ("fentanyl OUD", herein). This study is a participant- and assessor- blinded dose-finding study using the Bayesian optimal interval (BOIN) design.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male, female, transgender, or non-binary, aged 18 years or older
- DSM-5 criteria for opioid use disorder, moderate-severe
- Fentanyl positive urine drug test
- Able to provide a dated \& written informed consent in English prior to the conduct of any study related procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
You likely can't join if
- Hypersensitivity or allergy to methadone that is previously documented
- Pregnancy or actively lactating (with urine pregnancy test performed on screening and repeated on admission to the unit prior to randomization)
- Taking medications for opioid use disorder, per self-report or per urine drug testing detection of buprenorphine or methadone
- At risk of benzodiazepine or alcohol withdrawal as defined by: prior benzodiazepine or alcohol withdrawal in the past 3 months, current daily use of...
- At risk of severe medetomidine withdrawal based on: serum or urine testing for medetomidine (if available), prior withdrawal syndrome requiring...
- At risk for methadone-induced QT-prolongation: prolonged QTc on screening or admission EKG (greater than 450ms in men, greater than 460ms in women)...
See the full eligibility criteria
- Male, female, transgender, or non-binary, aged 18 years or older
- DSM-5 criteria for opioid use disorder, moderate-severe
- Fentanyl positive urine drug test
- Able to provide a dated \& written informed consent in English prior to the conduct of any study related procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to take oral medication and be willing to adhere to the dosage regimen
- Interest in starting methadone treatment for opioid use disorder at one of three locations: Merakey Parkside at 5000 Parkside, Merakey 5429 Germantown Avenue, or Merakey 1745 North 4th Street
- Reliable access to a working phone
- Hypersensitivity or allergy to methadone that is previously documented
- Pregnancy or actively lactating (with urine pregnancy test performed on screening and repeated on admission to the unit prior to randomization)
- Taking medications for opioid use disorder, per self-report or per urine drug testing detection of buprenorphine or methadone
- At risk of benzodiazepine or alcohol withdrawal as defined by: prior benzodiazepine or alcohol withdrawal in the past 3 months, current daily use of benzodiazepines or alcohol, or DSM-5 criteria for hypnotic-sedative or...
- At risk of severe medetomidine withdrawal based on: serum or urine testing for medetomidine (if available), prior withdrawal syndrome requiring intensive care unit admission within past 6 months, and/or severe...
- At risk for methadone-induced QT-prolongation: prolonged QTc on screening or admission EKG (greater than 450ms in men, greater than 460ms in women), history of QT prolongation, previously documented long QT syndrome...
- Significant hepatic dysfunction, defined as: AST and/or ALT 3x upper limit of normal, or total bilirubin 1.5x upper limit of normal
- Significant renal dysfunction, defined as: eGFR less than or equal to 60 mL/min
- Chronic hypotension (\<90/50 mmHg) or episodic symptomatic hypotension, defined as a history of active or recurrent orthostatic hypotension or syncope
- Significant pulmonary disease, defined as: baseline SpO2 \<95% on screening or admission, requiring oxygen at home (chronically or at bedtime), or COPD with modified MRC Dyspnea Scale greater than 2 ("I stop for breath...
- Suspected gastrointestinal obstruction, per medical history
- Active, chronic use of the CYP3A4-inducers or -inhibitors rifampin, phenytoin, St John's wort, phenobarbital, carbamazepine, voriconazole, efavirenz, nelfinavir, nevirapine, ritonavir, and lopinavir/ritonavir, abacavir...
- Pending legal action that could prohibit participation and/or compliance in study procedures
- Presence of any other psychiatric and/or medical disorder that, in the opinion of the PI, will interfere with completion of the study or place the patient at heightened risk through participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, 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.