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A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial.

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Τίτλος: A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial.
Συγγραφείς: Ray LA; Department of Psychology, University of California at Los Angeles.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.; Brain Research Institute, University of California at Los Angeles., Meredith LR; Department of Psychology, University of California at Los Angeles., Grodin EN; Department of Psychology, University of California at Los Angeles.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.; Brain Research Institute, University of California at Los Angeles., Belnap MA; Department of Psychology, University of California at Los Angeles.; Brain Research Institute, University of California at Los Angeles., Nieto SJ; Department of Psychology, University of California at Los Angeles., Baskerville WA; Department of Psychology, University of California at Los Angeles., Donato S; Department of Psychology, University of California at Los Angeles., Shoptaw SJ; Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California at Los Angeles., Gillis AJ; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles., Irwin MR; Department of Psychology, University of California at Los Angeles.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles., Miotto K; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles., Enders CK; Department of Psychology, University of California at Los Angeles.
Πηγή: JAMA network open [JAMA Netw Open] 2025 Apr 01; Vol. 8 (4), pp. e257523. Date of Electronic Publication: 2025 Apr 01.
Τύπος έκδοσης: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase II; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: American Medical Association Country of Publication: United States NLM ID: 101729235 Publication Model: Electronic Cited Medium: Internet ISSN: 2574-3805 (Electronic) Linking ISSN: 25743805 NLM ISO Abbreviation: JAMA Netw Open Subsets: MEDLINE
Imprint Name(s): Original Publication: Chicago, IL : American Medical Association, [2018]-
Ιατρικοί όροι (MeSH): Alcoholism*/drug therapy , Alcoholism*/immunology , Pyridines*/therapeutic use , Pyridines*/pharmacology , Phosphodiesterase Inhibitors*/therapeutic use, Humans ; Male ; Female ; Middle Aged ; Adult ; Double-Blind Method ; Treatment Outcome ; Indolizines ; Pyrazoles
Περίληψη: Importance: The neuroimmune system represents a promising target for novel medications for alcohol use disorder (AUD). Ibudilast is a neuroimmune modulator which selectively inhibits phosphodiesterases (PDE) 3, PDE4, PDE10, and PDE11, and macrophage migration inhibitory factor (MIF).
Objective: To test the efficacy of ibudilast for AUD compared with placebo.
Design, Setting, and Participants: This randomized clinical trial was a double-masked, phase 2 trial conducted at an academic research center between October 2018 and April 2023. Eligible participants were adults seeking treatment for moderate or severe AUD. After completing the 12-week treatment period, participants were followed up for an additional 4 weeks.
Interventions: Ibudilast taken twice daily in 50 mg doses for 12 weeks vs placebo.
Main Outcomes and Measures: Percentage of heavy drinking days; secondary efficacy outcomes included drinks per day, drinks per drinking day, and percentage of days abstinent. Registered exploratory analyses tested whether the effects of ibudilast of drinking outcomes were moderated by baseline depressive symptomatology. Registered exploratory analyses also tested whether ibudilast reduced inflammation compared with placebo, as indicated by circulating levels of proinflammatory markers over the 12-week trial. Additionally, a post hoc exploratory analysis investigated whether sex moderated the effect of ibudilast on drinking outcomes. Data were analyzed between October 2018 and April 2023.
Results: A total of 102 participants were enrolled in the study (mean [SD] age, 44.3 [10.8] years; 61 male [59.8%]; 24 Black [23.5%], 32 Hispanic [31.4%], 52 White [51.0%]). Baseline demographic characteristics and alcohol use patterns did not significantly differ between the 2 medication conditions. There was no significant difference between ibudilast vs placebo on percentage of heavy drinking days (β = 0.06, SE = 0.08 [95% CI, -0.09 to 0.21]; P = .46). There were no significant differences between ibudilast vs placebo on registered secondary outcomes. There were no significant effects of ibudilast compared with placebo on peripheral markers of inflammation. Moderation analyses found that baseline depressive symptomology (time 2 for drinks per drinking day: β = 0.25, SE = 0.11 [95% CI, 0.03 to 0.48]; P = .03) and sex (β = -2.48, SE = 1.07 [95% CI, -4.59 to -0.37]; P = .02) may moderate the effects of ibudilast.
Conclusions and Relevance: In this randomized clinical trial of ibudilast for the treatment of AUD, there was no support for the efficacy of ibudilast over placebo; additionally, no effect of ibudilast on markers of peripheral inflammation was observed. As novel treatments for AUD are developed for novel molecular targets, their effects may depend on mechanisms and moderators of efficacy.
Trial Registration: ClinicalTrials.gov Identifier: NCT03594435.
References: Expert Opin Investig Drugs. 2007 Jul;16(7):935-50. (PMID: 17594181)
Alcohol Clin Exp Res. 2019 Jul;43(7):1344-1359. (PMID: 31074877)
Trends Pharmacol Sci. 1997 May;18(5):164-71. (PMID: 9184477)
Neuropharmacology. 2004 Mar;46(3):404-11. (PMID: 14975696)
J Neuroimmune Pharmacol. 2013 Jun;8(3):576-93. (PMID: 23666436)
Psychol Bull. 2014 May;140(3):774-815. (PMID: 24417575)
Alcohol Clin Exp Res. 2019 Jan;43(1):158-169. (PMID: 30403402)
Prog Neuropsychopharmacol Biol Psychiatry. 2016 Feb 4;65:234-41. (PMID: 26188287)
Addict Biol. 2015 Jan;20(1):38-42. (PMID: 24215262)
J Clin Invest. 2023 Mar 15;133(6):. (PMID: 36656645)
PLoS One. 2010 Oct 15;5(10):e13417. (PMID: 20976216)
Neuropsychopharmacology. 2018 Mar;43(4):891-899. (PMID: 29154368)
Pharmacol Biochem Behav. 2019 Feb;177:34-60. (PMID: 30590091)
Transl Psychiatry. 2021 Jun 12;11(1):355. (PMID: 34120149)
Acta Neuropathol. 2014 Jan;127(1):71-90. (PMID: 24370929)
Neuropsychopharmacology. 2017 Jan;42(1):376. (PMID: 27909320)
Neuropsychopharmacology. 2021 Dec;46(13):2250-2256. (PMID: 34155332)
Neuropsychopharmacology. 2017 Aug;42(9):1776-1788. (PMID: 28091532)
J Consult Clin Psychol. 1994 Feb;62(1):75-82. (PMID: 8034833)
Nat Rev Immunol. 2003 Oct;3(10):791-800. (PMID: 14502271)
Alcohol Res. 2020 Oct 29;40(2):01. (PMID: 33133878)
Br J Addict. 1989 Nov;84(11):1353-7. (PMID: 2597811)
JAMA Psychiatry. 2022 Oct 1;79(10):953-962. (PMID: 36001306)
Expert Opin Investig Drugs. 2018 Jan;27(1):113-124. (PMID: 29241365)
Psychopharmacology (Berl). 2016 May;233(9):1543-57. (PMID: 25787746)
JAMA Intern Med. 2020 May 1;180(5):728-736. (PMID: 32150232)
Neuroreport. 2022 May 4;33(7):291-296. (PMID: 35594442)
Contemp Clin Trials. 2016 Sep;50:178-85. (PMID: 27521807)
Drug Alcohol Depend. 2008 Jan 11;93(1-2):21-9. (PMID: 17980512)
Brain Behav Immun. 2021 Oct;97:349-364. (PMID: 34343618)
Am J Drug Alcohol Abuse. 2023 May 4;49(3):333-344. (PMID: 36282988)
Handb Exp Pharmacol. 2018;248:369-396. (PMID: 29500721)
Int Rev Neurobiol. 2014;118:1-12. (PMID: 25175859)
Psychol Methods. 2019 Jun;24(3):309-338. (PMID: 29999378)
Grant Information: K01 AA029712 United States AA NIAAA NIH HHS; T32 HD091059 United States HD NICHD NIH HHS; R01 AA026190 United States AA NIAAA NIH HHS; F32 AA029288 United States AA NIAAA NIH HHS; K24 AA025704 United States AA NIAAA NIH HHS; F31 AA029295 United States AA NIAAA NIH HHS
Molecular Sequence: ClinicalTrials.gov NCT03594435
Substance Nomenclature: M0TTH61XC5 (ibudilast)
0 (Pyridines)
0 (Phosphodiesterase Inhibitors)
0 (Indolizines)
0 (Pyrazoles)
Entry Date(s): Date Created: 20250430 Date Completed: 20250430 Latest Revision: 20260416
Update Code: 20260416
PubMed Central ID: PMC12044506
DOI: 10.1001/jamanetworkopen.2025.7523
PMID: 40305022
Βάση Δεδομένων: MEDLINE
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  Data: A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial.
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  Data: <searchLink fieldCode="AU" term="%22Ray+LA%22">Ray LA</searchLink>; Department of Psychology, University of California at Los Angeles.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.; Brain Research Institute, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Meredith+LR%22">Meredith LR</searchLink>; Department of Psychology, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Grodin+EN%22">Grodin EN</searchLink>; Department of Psychology, University of California at Los Angeles.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.; Brain Research Institute, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Belnap+MA%22">Belnap MA</searchLink>; Department of Psychology, University of California at Los Angeles.; Brain Research Institute, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Nieto+SJ%22">Nieto SJ</searchLink>; Department of Psychology, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Baskerville+WA%22">Baskerville WA</searchLink>; Department of Psychology, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Donato+S%22">Donato S</searchLink>; Department of Psychology, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Shoptaw+SJ%22">Shoptaw SJ</searchLink>; Center for Behavioral and Addiction Medicine, Department of Family Medicine, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Gillis+AJ%22">Gillis AJ</searchLink>; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Irwin+MR%22">Irwin MR</searchLink>; Department of Psychology, University of California at Los Angeles.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Miotto+K%22">Miotto K</searchLink>; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles.<br /><searchLink fieldCode="AU" term="%22Enders+CK%22">Enders CK</searchLink>; Department of Psychology, University of California at Los Angeles.
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  Data: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase II; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural
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  Data: <searchLink fieldCode="MM" term="%22Alcoholism%22">Alcoholism*</searchLink>/<searchLink fieldCode="MM" term="%22Alcoholism+drug+therapy%22">drug therapy</searchLink> <br /><searchLink fieldCode="MM" term="%22Alcoholism%22">Alcoholism*</searchLink>/<searchLink fieldCode="MM" term="%22Alcoholism+immunology%22">immunology</searchLink> <br /><searchLink fieldCode="MM" term="%22Pyridines%22">Pyridines*</searchLink>/<searchLink fieldCode="MM" term="%22Pyridines+therapeutic+use%22">therapeutic use</searchLink> <br /><searchLink fieldCode="MM" term="%22Pyridines%22">Pyridines*</searchLink>/<searchLink fieldCode="MM" term="%22Pyridines+pharmacology%22">pharmacology</searchLink> <br /><searchLink fieldCode="MM" term="%22Phosphodiesterase+Inhibitors%22">Phosphodiesterase Inhibitors*</searchLink>/<searchLink fieldCode="MM" term="%22Phosphodiesterase+Inhibitors+therapeutic+use%22">therapeutic use</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Male%22">Male</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Middle+Aged%22">Middle Aged</searchLink> ; <searchLink fieldCode="MH" term="%22Adult%22">Adult</searchLink> ; <searchLink fieldCode="MH" term="%22Double-Blind+Method%22">Double-Blind Method</searchLink> ; <searchLink fieldCode="MH" term="%22Treatment+Outcome%22">Treatment Outcome</searchLink> ; <searchLink fieldCode="MH" term="%22Indolizines%22">Indolizines</searchLink> ; <searchLink fieldCode="MH" term="%22Pyrazoles%22">Pyrazoles</searchLink>
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  Data: Importance: The neuroimmune system represents a promising target for novel medications for alcohol use disorder (AUD). Ibudilast is a neuroimmune modulator which selectively inhibits phosphodiesterases (PDE) 3, PDE4, PDE10, and PDE11, and macrophage migration inhibitory factor (MIF).<br />Objective: To test the efficacy of ibudilast for AUD compared with placebo.<br />Design, Setting, and Participants: This randomized clinical trial was a double-masked, phase 2 trial conducted at an academic research center between October 2018 and April 2023. Eligible participants were adults seeking treatment for moderate or severe AUD. After completing the 12-week treatment period, participants were followed up for an additional 4 weeks.<br />Interventions: Ibudilast taken twice daily in 50 mg doses for 12 weeks vs placebo.<br />Main Outcomes and Measures: Percentage of heavy drinking days; secondary efficacy outcomes included drinks per day, drinks per drinking day, and percentage of days abstinent. Registered exploratory analyses tested whether the effects of ibudilast of drinking outcomes were moderated by baseline depressive symptomatology. Registered exploratory analyses also tested whether ibudilast reduced inflammation compared with placebo, as indicated by circulating levels of proinflammatory markers over the 12-week trial. Additionally, a post hoc exploratory analysis investigated whether sex moderated the effect of ibudilast on drinking outcomes. Data were analyzed between October 2018 and April 2023.<br />Results: A total of 102 participants were enrolled in the study (mean [SD] age, 44.3 [10.8] years; 61 male [59.8%]; 24 Black [23.5%], 32 Hispanic [31.4%], 52 White [51.0%]). Baseline demographic characteristics and alcohol use patterns did not significantly differ between the 2 medication conditions. There was no significant difference between ibudilast vs placebo on percentage of heavy drinking days (β = 0.06, SE = 0.08 [95% CI, -0.09 to 0.21]; P = .46). There were no significant differences between ibudilast vs placebo on registered secondary outcomes. There were no significant effects of ibudilast compared with placebo on peripheral markers of inflammation. Moderation analyses found that baseline depressive symptomology (time 2 for drinks per drinking day: β = 0.25, SE = 0.11 [95% CI, 0.03 to 0.48]; P = .03) and sex (β = -2.48, SE = 1.07 [95% CI, -4.59 to -0.37]; P = .02) may moderate the effects of ibudilast.<br />Conclusions and Relevance: In this randomized clinical trial of ibudilast for the treatment of AUD, there was no support for the efficacy of ibudilast over placebo; additionally, no effect of ibudilast on markers of peripheral inflammation was observed. As novel treatments for AUD are developed for novel molecular targets, their effects may depend on mechanisms and moderators of efficacy.<br />Trial Registration: ClinicalTrials.gov Identifier: NCT03594435.
– Name: Ref
  Label: References
  Group: RefInfo
  Data: Expert Opin Investig Drugs. 2007 Jul;16(7):935-50. (PMID: <searchLink fieldCode="PM" term="%2217594181%22">17594181)</searchLink><br />Alcohol Clin Exp Res. 2019 Jul;43(7):1344-1359. (PMID: <searchLink fieldCode="PM" term="%2231074877%22">31074877)</searchLink><br />Trends Pharmacol Sci. 1997 May;18(5):164-71. (PMID: <searchLink fieldCode="PM" term="%229184477%22">9184477)</searchLink><br />Neuropharmacology. 2004 Mar;46(3):404-11. (PMID: <searchLink fieldCode="PM" term="%2214975696%22">14975696)</searchLink><br />J Neuroimmune Pharmacol. 2013 Jun;8(3):576-93. (PMID: <searchLink fieldCode="PM" term="%2223666436%22">23666436)</searchLink><br />Psychol Bull. 2014 May;140(3):774-815. (PMID: <searchLink fieldCode="PM" term="%2224417575%22">24417575)</searchLink><br />Alcohol Clin Exp Res. 2019 Jan;43(1):158-169. (PMID: <searchLink fieldCode="PM" term="%2230403402%22">30403402)</searchLink><br />Prog Neuropsychopharmacol Biol Psychiatry. 2016 Feb 4;65:234-41. (PMID: <searchLink fieldCode="PM" term="%2226188287%22">26188287)</searchLink><br />Addict Biol. 2015 Jan;20(1):38-42. (PMID: <searchLink fieldCode="PM" term="%2224215262%22">24215262)</searchLink><br />J Clin Invest. 2023 Mar 15;133(6):. (PMID: <searchLink fieldCode="PM" term="%2236656645%22">36656645)</searchLink><br />PLoS One. 2010 Oct 15;5(10):e13417. (PMID: <searchLink fieldCode="PM" term="%2220976216%22">20976216)</searchLink><br />Neuropsychopharmacology. 2018 Mar;43(4):891-899. (PMID: <searchLink fieldCode="PM" term="%2229154368%22">29154368)</searchLink><br />Pharmacol Biochem Behav. 2019 Feb;177:34-60. (PMID: <searchLink fieldCode="PM" term="%2230590091%22">30590091)</searchLink><br />Transl Psychiatry. 2021 Jun 12;11(1):355. (PMID: <searchLink fieldCode="PM" term="%2234120149%22">34120149)</searchLink><br />Acta Neuropathol. 2014 Jan;127(1):71-90. (PMID: <searchLink fieldCode="PM" term="%2224370929%22">24370929)</searchLink><br />Neuropsychopharmacology. 2017 Jan;42(1):376. (PMID: <searchLink fieldCode="PM" term="%2227909320%22">27909320)</searchLink><br />Neuropsychopharmacology. 2021 Dec;46(13):2250-2256. (PMID: <searchLink fieldCode="PM" term="%2234155332%22">34155332)</searchLink><br />Neuropsychopharmacology. 2017 Aug;42(9):1776-1788. (PMID: <searchLink fieldCode="PM" term="%2228091532%22">28091532)</searchLink><br />J Consult Clin Psychol. 1994 Feb;62(1):75-82. (PMID: <searchLink fieldCode="PM" term="%228034833%22">8034833)</searchLink><br />Nat Rev Immunol. 2003 Oct;3(10):791-800. (PMID: <searchLink fieldCode="PM" term="%2214502271%22">14502271)</searchLink><br />Alcohol Res. 2020 Oct 29;40(2):01. (PMID: <searchLink fieldCode="PM" term="%2233133878%22">33133878)</searchLink><br />Br J Addict. 1989 Nov;84(11):1353-7. (PMID: <searchLink fieldCode="PM" term="%222597811%22">2597811)</searchLink><br />JAMA Psychiatry. 2022 Oct 1;79(10):953-962. (PMID: <searchLink fieldCode="PM" term="%2236001306%22">36001306)</searchLink><br />Expert Opin Investig Drugs. 2018 Jan;27(1):113-124. (PMID: <searchLink fieldCode="PM" term="%2229241365%22">29241365)</searchLink><br />Psychopharmacology (Berl). 2016 May;233(9):1543-57. (PMID: <searchLink fieldCode="PM" term="%2225787746%22">25787746)</searchLink><br />JAMA Intern Med. 2020 May 1;180(5):728-736. (PMID: <searchLink fieldCode="PM" term="%2232150232%22">32150232)</searchLink><br />Neuroreport. 2022 May 4;33(7):291-296. (PMID: <searchLink fieldCode="PM" term="%2235594442%22">35594442)</searchLink><br />Contemp Clin Trials. 2016 Sep;50:178-85. (PMID: <searchLink fieldCode="PM" term="%2227521807%22">27521807)</searchLink><br />Drug Alcohol Depend. 2008 Jan 11;93(1-2):21-9. (PMID: <searchLink fieldCode="PM" term="%2217980512%22">17980512)</searchLink><br />Brain Behav Immun. 2021 Oct;97:349-364. (PMID: <searchLink fieldCode="PM" term="%2234343618%22">34343618)</searchLink><br />Am J Drug Alcohol Abuse. 2023 May 4;49(3):333-344. (PMID: <searchLink fieldCode="PM" term="%2236282988%22">36282988)</searchLink><br />Handb Exp Pharmacol. 2018;248:369-396. (PMID: <searchLink fieldCode="PM" term="%2229500721%22">29500721)</searchLink><br />Int Rev Neurobiol. 2014;118:1-12. (PMID: <searchLink fieldCode="PM" term="%2225175859%22">25175859)</searchLink><br />Psychol Methods. 2019 Jun;24(3):309-338. (PMID: <searchLink fieldCode="PM" term="%2229999378%22">29999378)</searchLink>
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        Type: general
      – SubjectFull: Male
        Type: general
      – SubjectFull: Female
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      – SubjectFull: Alcoholism immunology
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      – TitleFull: A Neuroimmune Modulator for Alcohol Use Disorder: A Randomized Clinical Trial.
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            NameFull: Meredith LR
      – PersonEntity:
          Name:
            NameFull: Grodin EN
      – PersonEntity:
          Name:
            NameFull: Belnap MA
      – PersonEntity:
          Name:
            NameFull: Nieto SJ
      – PersonEntity:
          Name:
            NameFull: Baskerville WA
      – PersonEntity:
          Name:
            NameFull: Donato S
      – PersonEntity:
          Name:
            NameFull: Shoptaw SJ
      – PersonEntity:
          Name:
            NameFull: Gillis AJ
      – PersonEntity:
          Name:
            NameFull: Irwin MR
      – PersonEntity:
          Name:
            NameFull: Miotto K
      – PersonEntity:
          Name:
            NameFull: Enders CK
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 04
              Text: 2025 Apr 01
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-electronic
              Value: 2574-3805
          Numbering:
            – Type: volume
              Value: 8
            – Type: issue
              Value: 4
          Titles:
            – TitleFull: JAMA network open
              Type: main
ResultId 1