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Variations in alcohol craving and negative mood during a clinical trial of ibudilast for alcohol use disorder.

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Τίτλος: Variations in alcohol craving and negative mood during a clinical trial of ibudilast for alcohol use disorder.
Συγγραφείς: Meredith LR; Department of Psychology, University of California, Los Angeles, California, USA., Grodin EN; Department of Psychology, University of California, Los Angeles, California, USA.; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, California, USA.; Brain Research Institute, University of California, Los Angeles, California, USA., Enders CK; Department of Psychology, University of California, Los Angeles, California, USA., Ray LA; Department of Psychology, University of California, Los Angeles, California, USA.; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, California, USA.; Brain Research Institute, University of California, Los Angeles, California, USA.
Πηγή: Alcohol, clinical & experimental research [Alcohol Clin Exp Res (Hoboken)] 2025 Nov; Vol. 49 (11), pp. 2604-2618. Date of Electronic Publication: 2025 Oct 02.
Τύπος έκδοσης: Journal Article; Randomized Controlled Trial
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Wiley Periodicals Country of Publication: United States NLM ID: 9918609780906676 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2993-7175 (Electronic) Linking ISSN: 29937175 NLM ISO Abbreviation: Alcohol Clin Exp Res (Hoboken) Subsets: MEDLINE
Imprint Name(s): Original Publication: Hoboken, NJ : Wiley Periodicals, [2023]-
Ιατρικοί όροι (MeSH): Affect*/drug effects , Alcoholism*/drug therapy , Alcoholism*/psychology , Alcoholism*/diagnostic imaging , Craving*/drug effects , Pyridines*/therapeutic use, Adult ; Female ; Humans ; Male ; Middle Aged ; Anxiety ; Depression ; Double-Blind Method ; Magnetic Resonance Imaging ; Secondary Data Analysis ; Indolizines ; Pyrazoles
Περίληψη: Background: Immune medications, including ibudilast, have shown early potential in mitigating alcohol intake in preclinical models and small-scale trials for alcohol use disorder (AUD). To elucidate clinical utility and clinical mechanisms of these novel treatments, research should carefully assess medication-related changes in AUD symptomatology, including craving and negative mood, over time.
Methods: This is a secondary analysis of a 12-week randomized clinical trial of ibudilast for AUD. Participants were 102 individuals (40% female, average age 44 years) seeking treatment for AUD and randomized to ibudilast (50 mg twice-daily) or matched placebo. Clinical symptom measures of alcohol craving, depression, and anxiety were collected monthly. Growth models compared rates of change in clinical symptomatology between treatment groups and tested whether changes were moderated by sex. A subsample (n = 25) completed a functional magnetic resonance imaging scan with an alcohol cue-reactivity task at week four to assess a brain-based craving marker.
Results: At pretreatment, participants reported moderate craving symptoms and nonclinically elevated negative mood symptoms, on average. Participants taking ibudilast showed significantly steeper reductions in craving during the trial, as compared with placebo (1.32 vs. 0.52 points lower per month; p = 0.035). At treatment endpoint, female participants taking ibudilast reported lower craving than female participants taking placebo (p < 0.001). Greater cue-elicited brain activation in bilateral insula, bilateral orbitofrontal cortex, and right precuneus (p's < 0.02) was detected among the placebo subsample, compared to ibudilast. Rates of change for depression and anxiety did not differ between medication conditions, nor were they moderated by sex. Depression symptoms decreased during the trial, while anxiety symptoms remained relatively stable.
Conclusions: Consistent with prior research, ibudilast reduced neurobiological and self-report markers of craving, with female participants showing a stronger treatment response by trial endpoint. Despite shared neuroimmune correlates between negative mood and addiction, ibudilast did not alleviate negative mood symptoms beyond placebo effects.
(© 2025 The Author(s). Alcohol, Clinical and Experimental Research published by Wiley Periodicals LLC on behalf of Research Society on Alcohol.)
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Grant Information: F32AA027699 United States AA NIAAA NIH HHS; K24 AA025704 United States AA NIAAA NIH HHS; K01AA029712 United States AA NIAAA NIH HHS; F31 AA029295 United States AA NIAAA NIH HHS; Anthony Pritzker Family Foundation; R01 AA026190 United States AA NIAAA NIH HHS; K24AA025704 United States AA NIAAA NIH HHS; F31AA029295 United States AA NIAAA NIH HHS; F32 AA027699 United States AA NIAAA NIH HHS; R01AA026190 United States AA NIAAA NIH HHS; K01 AA029712 United States AA NIAAA NIH HHS
Contributed Indexing: Keywords: alcohol use disorder; craving; immune; negative mood; pharmacotherapy
Substance Nomenclature: M0TTH61XC5 (ibudilast)
0 (Pyridines)
0 (Indolizines)
0 (Pyrazoles)
Entry Date(s): Date Created: 20251003 Date Completed: 20251121 Latest Revision: 20260127
Update Code: 20260130
PubMed Central ID: PMC12638289
DOI: 10.1111/acer.70178
PMID: 41039752
Βάση Δεδομένων: MEDLINE
FullText Text:
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DbLabel: MEDLINE
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PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Variations in alcohol craving and negative mood during a clinical trial of ibudilast for alcohol use disorder.
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  Data: Background: Immune medications, including ibudilast, have shown early potential in mitigating alcohol intake in preclinical models and small-scale trials for alcohol use disorder (AUD). To elucidate clinical utility and clinical mechanisms of these novel treatments, research should carefully assess medication-related changes in AUD symptomatology, including craving and negative mood, over time.&lt;br /&gt;Methods: This is a secondary analysis of a 12-week randomized clinical trial of ibudilast for AUD. Participants were 102 individuals (40% female, average age 44 years) seeking treatment for AUD and randomized to ibudilast (50 mg twice-daily) or matched placebo. Clinical symptom measures of alcohol craving, depression, and anxiety were collected monthly. Growth models compared rates of change in clinical symptomatology between treatment groups and tested whether changes were moderated by sex. A subsample (n = 25) completed a functional magnetic resonance imaging scan with an alcohol cue-reactivity task at week four to assess a brain-based craving marker.&lt;br /&gt;Results: At pretreatment, participants reported moderate craving symptoms and nonclinically elevated negative mood symptoms, on average. Participants taking ibudilast showed significantly steeper reductions in craving during the trial, as compared with placebo (1.32 vs. 0.52 points lower per month; p = 0.035). At treatment endpoint, female participants taking ibudilast reported lower craving than female participants taking placebo (p &amp;lt; 0.001). Greater cue-elicited brain activation in bilateral insula, bilateral orbitofrontal cortex, and right precuneus (p&#39;s &amp;lt; 0.02) was detected among the placebo subsample, compared to ibudilast. Rates of change for depression and anxiety did not differ between medication conditions, nor were they moderated by sex. Depression symptoms decreased during the trial, while anxiety symptoms remained relatively stable.&lt;br /&gt;Conclusions: Consistent with prior research, ibudilast reduced neurobiological and self-report markers of craving, with female participants showing a stronger treatment response by trial endpoint. Despite shared neuroimmune correlates between negative mood and addiction, ibudilast did not alleviate negative mood symptoms beyond placebo effects.&lt;br /&gt; (&#169; 2025 The Author(s). Alcohol, Clinical and Experimental Research published by Wiley Periodicals LLC on behalf of Research Society on Alcohol.)
– Name: Ref
  Label: References
  Group: RefInfo
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        Text: English
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      – SubjectFull: Adult
        Type: general
      – SubjectFull: Female
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      – SubjectFull: Humans
        Type: general
      – SubjectFull: Male
        Type: general
      – SubjectFull: Middle Aged
        Type: general
      – SubjectFull: Anxiety
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      – SubjectFull: Depression
        Type: general
      – SubjectFull: Double-Blind Method
        Type: general
      – SubjectFull: Magnetic Resonance Imaging
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      – SubjectFull: Secondary Data Analysis
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      – SubjectFull: Alcoholism drug therapy
        Type: general
      – SubjectFull: Alcoholism psychology
        Type: general
      – SubjectFull: Alcoholism diagnostic imaging
        Type: general
      – SubjectFull: Craving drug effects
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      – SubjectFull: Pyridines therapeutic use
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    Titles:
      – TitleFull: Variations in alcohol craving and negative mood during a clinical trial of ibudilast for alcohol use disorder.
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            – D: 01
              M: 11
              Text: 2025 Nov
              Type: published
              Y: 2025
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            – TitleFull: Alcohol, clinical & experimental research
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