Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 8, 2024
Date Accepted: Jun 4, 2025
Use of Naltrexone for Stimulant Use Disorder (StUD) among Stimulants Users in Malaysia: Protocol of a retrospective cohort study
ABSTRACT
Background:
Naltrexone (NT) is an opioid receptor antagonist. NT is used to block the euphoric and sedative effects of drugs such as heroin, codeine and morphine. The medication helps to bind and block opioid receptors in order to decrease the opioid craving. In Malaysia, NT has been used for maintenance treatments for heroin and alcohol since 1996. However, since 2011, NT has been used as an off label to treat stimulant use disorder (StUD) to achieve abstinence.
Objective:
The aim of this study is to determine the abstinence among StUD and non-StUD patients treated with and without NT.
Methods:
We will conduct a retrospective cohort study on the effect of NT or treatment as usual (TAU) by examining the data for both StUD and non-StUD patients. We will utilize patients’ clinical record from the hospital registry. All the adult patients (aged 18 - 65 years old) who were diagnosed with StUD or non-StUD treated with NT and standard care from 1 January 2011 to 31 December 2023 will be screened. All StUD and non-StUD patients who were offered the NT treatment or with TAU at the beginning of treatment will be recruited. All data will be extracted using a standardized data extraction form. Descriptive analysis will be performed to describe the distribution on the characteristic of the patients, sociodemographic profiles and percentage of abstinence and treatment retention. We will conduct univariable analysis to determine the association of stimulant abstinence, as well as treatment retention between NT and TAU among both StUD and non-StUD patients. All significant independent variables will be further analyzed using cross-sectional time series method for categorical variables.
Results:
Recruitment is scheduled to begin in June 2025. Data analysis will begin after completing data collection, planned in January 2026. The expected main outcome of this study is to observe the significant associations of StUD abstinence, as well as treatment retention between TAU and NT among StUD and non-StUD patients are expected to be observed. The findings from this study may provide preliminary evidence regarding the use of NT in treating StUD.
Conclusions:
Currently, there is no specific medication to treat amphetamine, or methamphetamine use disorder. The effect of NT with psychosocial interventions for StUD is unclear. Public health approaches recognize the multi-faceted nature of substance misuse and focus on addressing the myriads of individuals, environmental, and social factors that contribute to StUD.
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