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Nalmefene in Alcohol Use Disorder Subjects with Psychiatric Comorbidity: A Naturalistic Study

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Abstract

Introduction

Nalmefene is the first drug to be approved for reducing alcohol consumption in alcohol use disorder (AUD) patients at high drinking risk. In real-world settings, there is a high prevalence of concurrent psychiatric disorders in AUD subjects, with associated increased morbidity and worse prognosis. This study evaluated the use of nalmefene in AUD patients with stabilized psychiatric comorbidity previously treated unsuccessfully for alcohol dependence, and assessed craving reduction and safety.

Methods

Sixty-five AUD outpatients treated with as-needed 18 mg nalmefene for 24 weeks were included. Primary outcome measures were: changes in heavy drinking days (HDDs) and total alcohol consumption (TAC, g/day). Secondary outcome measures were: changes in drinking risk level and craving (obsessive–compulsive drinking scale and visual analogue scale for craving).

Results

Forty-two AUD subjects (64.6%) had one or more stabilized psychiatric comorbidity. There was a significant reduction in HDDs, TAC and craving measures (p < 0.001), with no differences between subjects with and without psychiatric comorbidity. Nalmefene was safe and well tolerated in all patients.

Conclusion

As-needed nalmefene reduced drinking and craving in AUD subjects with and without psychiatric comorbidity. These findings suggest that nalmefene is a valid therapeutic option in real-world clinical settings, where comorbid conditions are common, and has the potential to engage AUD patients who may otherwise not have sought help.

Funding

Lundbeck Italia S.P.A.

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Acknowledgements

No funding or sponsorship was received for this study. Article processing charges were funded by Lundbeck Italia S.P.A. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published.

Disclosures

Marco Di Nicola, Sergio De Filippis, Giovanni Martinotti, Luisa De Risio, Mauro Pettorruso, Simone De Persis, Angelo Giovanni Icro Maremmani, Icro Maremmani, Massimo di Giannantonio and Luigi Janiri have nothing to disclose.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 and 2008. Informed consent was obtained from all patients before being included in the study.

Data Availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

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Correspondence to Marco Di Nicola.

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Di Nicola, M., De Filippis, S., Martinotti, G. et al. Nalmefene in Alcohol Use Disorder Subjects with Psychiatric Comorbidity: A Naturalistic Study. Adv Ther 34, 1636–1649 (2017). https://doi.org/10.1007/s12325-017-0546-3

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