Table 1

Eligibility criteria

Inclusion criteriaExclusion criteria
All participants must/must be:All participants must not:
  • ≥18 years of age

  • Be currently pregnant, breastfeeding or planning on becoming pregnant during the course of the study

  • Able to provide informed consent

  • Have presence of any psychiatric or physical comorbidity that would interfere with study participation

  • Meet DSM-5-TR diagnostic criteria for Stimulant Use Disorder – Amphetamine-Type Substance (methamphetamine), as determined by a specialist in addiction medicine or psychiatry

  • Have coexisting dependence on or withdrawal from alcohol, non-prescribed benzodiazepines or GHB, or undergoing treatment for any other substance use disorder which in the opinion of the site principal investigator would interfere with study participation (with the exception of cannabis and nicotine)

  • Opioid-free for at least 7 days by self-report

  • Be currently receiving opioid analgesics, or:

    1. Dependent on opioids,

    2. In acute opioid withdrawal, or

    3. Has an anticipated need for opioid-containing medications at any point during the study (eg, planned surgery)

  • Provide a urine drug screen point of care test positive for methamphetamines (during screening) and negative for opioids (during screening, repeated on the first day of study drug)

  • Likely or planned surgery, travel, incarceration or other engagement during the study period that may interfere with study participation

  • Willing to avoid pregnancy for study duration if a person of childbearing potential

  • Have a history of sensitivity to naltrexone, bupropion or any other components of investigational product

  • Willing and able to comply with all study requirements, including the ability to store study medications securely

  • Be currently treated with any other preparation containing bupropion or naltrexone

  • Agree to use a smartphone to self-report daily adherence to the provided medication and daily methamphetamine use

  • Have acute hepatitis, liver failure or liver impairment (aspartate aminotransferase or alanine transaminase >5 times upper limit of normal (ULN), total bilirubin>ULN)

  • Have a seizure disorder or any history of seizures

  • Have a known CNS tumour

  • Have a current or previous diagnosis of bulimia or anorexia nervosa

  • Be concomitantly prescribed MAOIs (at least 14 days should elapse between discontinuation of MAOIs and initiation of treatment with the investigational product)

  • Have hypertension uncontrolled by a single antihypertensive agent

  • Currently enrolled in another treatment trial of MAUD or clinical trial which would interfere in participation in this study as determined by the PI

  • CNS, Central Nervous System; DSM-5 TR, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision; GHB, gamma-hydroxybutyrate; MAOI, monoamine oxidase inhibitor; MAUD, methamphetamine use disorder; PI, principal investigator.