Trial protocol of an open-label pilot study of oral <u>na</u>ltrexone-<u>bu</u>propion combination pharmacotherapy for the treatment of methamphetamine use disorder (the NABU trial).

ABSTRACT:

Introduction

Methamphetamine use disorder is a global public health concern with no approved pharmacotherapies for its treatment. One recent randomised controlled trial conducted in the USA examined a combination of bupropion and naltrexone not readily available globally. Here, we report a trial protocol for an oral formulation of combined naltrexone and bupropion.

Methods and analysis

This single-arm, open-label pilot study will assess the safety and feasibility of oral naltrexone and bupropion (40 mg/450 mg daily in divided doses) in adults with methamphetamine use disorder. Participants (n=20) will be outpatients of a stimulant treatment program at an inner-city hospital in Sydney, Australia. The primary endpoint is Day 84. Participants will attend weekly study visits fro

SUBMITTER: Siefried KJ 

PROVIDER: S-EPMC11808914 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature