altrexone and bupropion for the treatment of methamphetamine use disorder

Phase 4

• Conditions: Addiction; Methamphetamine use disorder; Mental Health - Addiction

• Registration Number: ACTRN12623000866606
• Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-11
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Greater than or equal to 18 years of age

Able to provide informed consent

Interested in managing, reducing, or stopping methamphetamine use

Meet DSM-5-TR diagnostic criteria for Stimulant Use Disorder – Amphetamine-Type Substance assessed at enrolment

Self-report methamphetamine use at least 14 days out of the previous 28 at baseline using the Timeline Follow-back (TLFB) method, assessed within 24 hours of first scheduled study dose

Opioid free for at least 7 concurrent days (self-report), assessed within 24 hours of first scheduled study dose

Provide a urine sample positive for methamphetamine and negative for opioids within 24 hours of first scheduled study dose

If person of childbearing potential, willingness to undergo a pregnancy test within 24 hours of first scheduled study dose and avoid pregnancy during the entire study duration

Meet subjective and objective measures of being opioid-free prior to naltrexone induction, according to the determination of the PI at enrolment

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

Agree to use a smartphone to self-report daily adherence to the study medication

Exclusion Criteria

Currently pregnant or breastfeeding, or planning on becoming pregnant during the course of the study

Presence of any psychiatric or physical comorbidity that would interfere with study participation as assessed by the PI

Presence of any factors that increase risk of seizure, including a history of epilepsy, seizure disorder, or head trauma with associated loss of consciousness that required hospitalisation, current anorexia nervosa or bulimia, or any other conditions that increase seizure risk in the opinion of the study’s medical monitor

Coexisting dependence on alcohol, benzodiazepines, GHB, or opiates, or undergoing treatment for any other substance use disorder

Expected need for opioid-containing medications at any point during the study (e.g. planned surgery)

Current use of medications associated with serotonin syndrome, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)

Liver function tests (LFT) indicating elevated levels as follows: AST/ALT results > 5 times ULN, total bilirubin > 2 times ULN, or platelets below 75 x 103/µL

Contraindications for naltrexone hydrochloride as per the Australian Product Information Sheet:
oPatients receiving opioid analgesics.
oPatients currently dependent on opioids since an acute withdrawal syndrome may ensue.
oPatients in acute opioid withdrawal.
oAny individual with a history of sensitivity to naltrexone or any other components of this product. It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids.
oAny individual with acute hepatitis or liver failure. Naltrexone GH should not be given to patients with acute hepatitis or liver failure.

Contraindications for bupropion hydrochloride sustained release tablets as per the Australian Product Information Sheet:
oPatients with hypersensitivity to bupropion or any of the other components of the preparation.
oPatients with a current seizure disorder or any history of seizures.
oPatients with a known central nervous system (CNS) tumour.
oPatients undergoing abrupt withdrawal from alcohol or benzodiazepines.
oPatients currently being treated with any other preparation containing bupropion as the incidence of seizures is dose dependent.
oPatients with a current or previous diagnosis of bulimia or anorexia nervosa.
oConcomitant use of bupropion hydrochloride and monoamine oxidase inhibitors (MAOIs). At least 14 days should elapse between discontinuation of MAOIs and initiation of treatment with bupropion hydrochloride tablets.

Study & Design

• Study Type: Interventional
• Study Design: Not specified