Opioid Use Disorder study: Methadone hydrochloride
Official title MethaLoad Dose-Finding Study
ClinicalTrials.gov ID: NCT06877858
What this study is testing
What is Methadone hydrochloride?
An investigational methadone loading dose strategy being studied for opioid use disorder (OUD) in people who use fentanyl.
Also referred to as Methadone.
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 is testing whether a higher first dose of methadone is safe and comfortable for people who use fentanyl. It also looks for the best dose to use in future studies.
- Who it's for
- You may be able to join if you are an adult with opioid use disorder who uses fentanyl.
- What's involved
- You will start methadone while staying in a hospital unit. You will receive either the usual low dose or one of four higher doses, chosen by chance. Neither you nor the staff who check your symptoms will know which dose you get.
- Time commitment
- The study lasts a few weeks while you stay in the hospital and have regular check‑ins. You will need to stay for the initial dosing period and attend follow‑up visits as directed.
- Phase 1: an early, usually small safety study
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 a partner location
- 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 is enrolling
- Philadelphia, Pennsylvania, 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, but 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?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.