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MethaLoad Dose-Finding Study

ConditionOpioid Use Disorder (OUD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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. Investigators aim to recruit n=24 participants with fentanyl OUD to a research unit for monitored methadone initiation. Participants will be randomized to standard initiation vs. loading dose initiation at one of four doses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 alcohol use disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methadone hydrochloride

    Drug

    Methadone loading dose initiation (vs. standard initiation in the TAU arm)

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Treatment as usual (TAU)Active comparator 1 intervention
Group B: Loading DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT) rate

The primary objective of the study is to identify a methadone loading dose approach appropriate for future study as an alternative initiation strategy for individuals with OUD using fentanyl or other high-potency synthetic opioids. The loading dose appropriate for future study will be identified as the highest loading dose with a dose-limiting toxicity (DLT) rate less than 10%. DLT definition: the proportion of individuals in each loading dose arm who meet any one of four safety outcomes within 24 hours of methadone loading dose administration: (1) Richmond Agitation-Sedation Scale (RASS) less than -1, (2) respiratory rate (RR) less than 8 breaths per minute, (3) peripheral oxygen saturation (SpO2) less than 92%, or (4) corrected QT interval (QTc) greater than 500ms.

Time frame
24 hours

Secondary outcomes

1

Opioid withdrawal severity

Peak and time-weighted mean subjective opioid withdrawal (using the Subjective Opioid Withdrawal Scale, SOWS) and the Clinical Opiate Withdrawal Scale (COWS) over 24 hours after initial methadone dose

Time frame
24 hours
2

Opioid craving

Peak and time-weighted mean opioid craving, using a visual analogue scale (VAS) assessment (1-100) over 24 hours after initial methadone dose

Time frame
24 hours after initial methadone dose
3

Peak plasma methadone concentration

Peak plasma methadone concentration after initial loading dose (Day 1) and after first maintenance dose (Day 2)

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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