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Published in: Trials 1/2020

Open Access 01-12-2020 | Study protocol

Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial

Authors: Elizabeth M. Burnette, Wave-Ananda Baskerville, Erica N. Grodin, Lara A. Ray

Published in: Trials | Issue 1/2020

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Abstract

Background

Alcohol use disorder (AUD) is a chronic and relapsing condition for which current pharmacological treatments are only modestly effective. The development of efficacious medications for AUD remains a high research priority with recent emphasis on identifying novel molecular targets for AUD treatment and to efficiently screen new compounds aimed at those targets. Ibudilast, a phosphodiesterase inhibitor, has been advanced as a novel addiction pharmacotherapy that targets neurotrophin signaling and neuroimmune function.

Methods

This study will conduct a 12-week, double-blind, placebo controlled randomized clinical trial of ibudilast (50 mg BID) for AUD treatment. We will randomize 132 treatment-seeking men and women with current AUD. We will collect a number of alcohol consumption outcomes. Primary among these is percent heavy drinking days (PHDD); secondary drinking outcomes include drinks per day, drinks per drinking day, percent days abstinent, percent subjects with no heavy drinking days, and percent subjects abstinent, as well as measures of alcohol craving and negative mood. Additionally, participants will have the option to opt-in to a neuroimaging session in which we examine the effects of ibudilast on neural activation to psychosocial stress and alcohol cues. Finally, we will also collect plasma levels of proinflammatory markers, as well as subjective and biological (salivary cortisol) markers of stress response.

Discussion

This study will further develop ibudilast, a safe and promising novel compound with strong preclinical and clinical safety data for AUD, and will probe biological mechanisms underlying the effects of Ibudilast on stress, neuroinflammation, and alcohol cue-reactivity and craving. If ibudilast proves superior to placebo in this study, it will set the stage for a confirmatory multi-site trial leading to FDA approval of a novel AUD treatment.

Trial registration

ClinicalTrials.gov NCT03594435 “Ibudilast for the Treatment of Alcohol Use Disorder”. Registered on 20 July 2018.
Appendix
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Metadata
Title
Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
Authors
Elizabeth M. Burnette
Wave-Ananda Baskerville
Erica N. Grodin
Lara A. Ray
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04670-y

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