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Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
Elizabeth M Burnette1,2, Wave-Ananda Baskerville3, Erica N Grodin3
1Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA. eburnette@g.ucla.edu.
Trials
|September 11, 2020
Summary
This clinical trial investigates ibudilast as a novel treatment for alcohol use disorder (AUD). The study aims to determine if ibudilast reduces heavy drinking days and craving in AUD patients.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Medicine
Background:
- Alcohol use disorder (AUD) is a chronic condition with limited effective pharmacological treatments.
- Novel molecular targets and compounds are needed for AUD treatment.
- Ibudilast, a phosphodiesterase inhibitor, targets neurotrophin signaling and neuroimmune function for addiction pharmacotherapy.
Purpose of the Study:
- To evaluate the efficacy of ibudilast in treating alcohol use disorder (AUD).
- To assess the effects of ibudilast on alcohol consumption, craving, and mood.
- To explore the impact of ibudilast on neuroinflammation, stress response, and neural reactivity to alcohol cues.
Main Methods:
- A 12-week, double-blind, placebo-controlled randomized clinical trial involving 132 treatment-seeking individuals with AUD.
- Primary outcome: percent heavy drinking days (PHDD). Secondary outcomes: drinks per day, abstinence rates, craving, and mood.
- Optional neuroimaging and collection of inflammatory and stress markers (proinflammatory markers, salivary cortisol).
Main Results:
- This section is to be filled after the study is completed.
Conclusions:
- Ibudilast is a safe, promising compound for AUD with potential to reduce craving and heavy drinking.
- The study will elucidate mechanisms of ibudilast's action on stress, neuroinflammation, and cue-reactivity.
- Positive results could lead to a confirmatory trial for FDA approval of ibudilast for AUD treatment.
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