FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Gender- and sex-sensitive psychopharmacotherapy of alcohol use disorder: a systematic review and meta-analysis protocol

Por: Hiss · I. C. · Hoffmann · S. · Reinhard · I. · Siegmann · E.-M. · Bach · P. · Kiefer · F. · Fischer · R. · Jäger · K. · Lenz · B.
Introduction

Alcohol use disorder (AUD) is a prevalent, chronic condition generating considerable global morbidity, mortality and socioeconomic burden. Despite the availability of established pharmacotherapies, overall treatment uptake remains low and effect sizes are moderate at best. Emerging evidence highlights substantial differences in treatment response between sexes and genders, yet these factors are rarely systematically considered in clinical trials or routine care. Existing reviews have limited scope and often exclude gender-diverse populations. This project aims to (1) Synthesise evidence on gender- and sex-specific efficacy, safety and adherence in AUD pharmacotherapies, (2) Evaluate the consideration of sex and gender beyond binary classifications in existing research and (3) Develop recommendations for gender- and sex-sensitive treatment strategies.

Methods and analysis

A systematic review and meta-analysis will be conducted using (PubMed, Web of Science, Scopus, Google Scholar, German Clinical Trials Register and ClinicalTrials.gov). We will include randomised controlled trials of pharmacotherapies for AUD with a minimum treatment duration of 4 weeks, reporting gender-specific and/or sex-specific results. The literature search will cover studies published up to October 2025, with inclusion restricted to articles published in English or German, regardless of setting. Two reviewers will independently screen records and assess risk of bias (Cochrane RoB), with evidence certainty evaluated using Grading of Recommendations Assessment, Development and Evaluation and aligned to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 and Sex and Gender Equity in Research guidelines.

Ethics and dissemination

Ethics approval is not required as only data from already completed studies and supplementary information directly provided by study authors are used. Findings and recommendations will be disseminated in peer-reviewed journals and presented at conferences and workshops.

PROSPERO registration number

CRD420251079160.

Impact of dextroamphetamine substitution on the use of illicit amphetamines in adults with amphetamine dependence: a study protocol for the multicentre double blind randomised controlled trial ATLAS4Dependence

Por: Chalabianloo · F. · Fadnes · L. T. · Mordal · J. · Spigset · O. · Loberg · E.-M. · Halmoy · A. · Lid · T. G. · Andersen · C. D. · Daltveit · J. T. · Assmus · J. · Erga · A. H. · K Solli · K. · Askjer · J. F. · Hansen · M. A. K. · Ohldieck · C. · Ezard · N. · Lintzeris · N. · Johansson · K
Introduction

There is limited evidence on how to effectively treat individuals from marginalised populations with dependence on amphetamine and/or methamphetamine (collectively referred to hereafter as amphetamine dependence). The disease burden is extremely high in this population, especially related to psychiatric comorbidities, cardiovascular complications, injection-related infections and poor social functioning. ATLAS4Dependence is a multi-centre randomised, placebo-controlled, double-blind trial that will investigate the effectiveness and safety of substitution treatment with dextroamphetamine compared with placebo in people with amphetamine dependence.

Methods and analysis

The trial will recruit 226 adult patients in several outpatient clinics in Norway.Inclusion criteria comprise individuals with amphetamine dependence, defined as use on three or more days per week during the past 28 days, who currently inject or have formerly injected drugs. This includes individuals both with and without comorbid opioid dependence, as well as those currently receiving or not receiving opioid agonist treatment. Participants will be randomly assigned 1:1 to receive either dextroamphetamine or placebo for 12 weeks. Flexible doses within the range of 30–120 mg daily will be provided based on individual assessments. The participants in both arms will be offered standard psychosocial and medical follow-up in accordance with current clinical practice. The endpoint assessments will be conducted at 12 weeks with weekly self-reports and safety assessments and a follow-up assessment at 52 weeks. The primary objective of the study is to assess the impact of 12 weeks daily prescribed oral dextroamphetamine versus placebo on the use of illicit amphetamines as well as on the total amount of amphetamines used (including both illicit and prescribed sources). Secondary outcomes are the differences between the groups at 12 weeks regarding psychological distress, symptoms of psychosis, quality of life, cardiovascular risk factors, injection-related infections, executive functioning, attention-deficit hyperactivity disorder-related symptoms, sleep, violence risk, fatigue, symptoms of craving and withdrawal, treatment retention, days of use of illicit amphetamines and use at 4 weeks and 8 weeks during the intervention period, use of other illicit substances and alcohol, as well as a cost-effectiveness analysis (using private economy, criminal activity and health service utilisation) and a qualitative approach to assess overall experiences with the study intervention. Analysis and reporting will follow the Consolidated Standards of Reporting Trials guidelines. All tests will be two-sided. Descriptive results and the estimated effectiveness will be presented with 95% CIs. The difference between the groups at the primary time point (at the end of the 12-week trial) will be assessed using 2 test (for use of illicit amphetamines measured by monthly urine tests) and Analysis of Covariance (ANCOVA) (for weekly self-reported total amount of amphetamines). Analyses for the primary endpoint will be undertaken on an intention-to-treat basis and reported on as such, but sensitivity analyses with per protocol analyses will also be presented.

Ethics and dissemination

The study is approved by European Medicines Agency, Clinical Trial Information System (CTIS). Written informed consent will be obtained from all patients. Study results will be published in international peer-reviewed medical journals.

Trial registration number

CTIS 2023-510404-44-00.

Economic evaluation of Koreas COVID-19 response projects in Uzbekistan

Por: Song · E.-M. · Kwon · Y. D. · Noh · J.-W.
Objectives

This study aims to assess the economic feasibility and broader policy implications of the Korea International Cooperation Agency’s (KOICA) official development assistance (ODA) projects for the COVID-19 emergency response in Uzbekistan through a cost–benefit analysis. The primary research question is to evaluate whether the interventions provide sufficient economic returns relative to their costs while informing future pandemic preparedness of response strategies.

Design

A cost–benefit analysis using quantitative methods was performed to assess the financial impact of the COVID-19 ODA projects.

Setting

The study was conducted in Uzbekistan, focusing on KOICA’s COVID-19 emergency response projects from January 2020 to December 2021.

Interventions

The intervention involved the implementation of KOICA’s COVID-19 emergency response activities, including early diagnosis support, establishment of rapid response bases, provision of medical equipment and emergency relief efforts in Uzbekistan.

Primary and secondary outcome measures

The primary outcome measure is the net present value (NPV) and benefit/cost ratio of the project. Secondary outcome measures are the project’s effectiveness in terms of death prevention, reduction in medical costs and timely COVID-19 testing.

Results

The analysis revealed a total programme cost of US$11 353 173, with a net benefit ranging from US$21 026 032 to US$34 573 403, and a benefit/cost ratio between 1.85 and 3.05. A detailed examination of costs and benefits highlighted the programme’s positive NPV and benefit/cost ratio, indicating its economic feasibility. The study also underscored the programme’s effectiveness in preventing deaths, reducing medical costs and providing timely COVID-19 testing.

Conclusions

The findings confirm that KOICA’s COVID-19 emergency response projects in Uzbekistan were economically viable and effective. The study highlights the importance of integrating economic evaluations into ODA assessments, particularly for emergency response and infectious disease control. It recommends expanding the use of quantitative analysis to optimise resource allocation and improve decision-making in future global health crises.

❌