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Leveraging meta-regression to test if medication effects on cue-induced craving are associated with clinical efficacy.

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Title: Leveraging meta-regression to test if medication effects on cue-induced craving are associated with clinical efficacy.
Authors: Nieto SJ; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA. snieto@psych.ucla.edu., Du H; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA., Meredith LR; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA., Donato S; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA., Magill M; Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island, USA., Ray LA; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles, Los Angeles, CA, USA.
Source: Psychopharmacology [Psychopharmacology (Berl)] 2024 Aug; Vol. 241 (8), pp. 1679-1689. Date of Electronic Publication: 2024 Apr 13.
Publication Type: Journal Article; Meta-Analysis
Language: English
Journal Info: Publisher: Springer-Verlag Country of Publication: Germany NLM ID: 7608025 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-2072 (Electronic) Linking ISSN: 00333158 NLM ISO Abbreviation: Psychopharmacology (Berl) Subsets: MEDLINE
Imprint Name(s): Original Publication: Berlin, New York, Springer-Verlag.
MeSH Terms: Craving*/drug effects , Alcoholism*/drug therapy , Alcoholism*/psychology , Cues* , Randomized Controlled Trials as Topic*, Alcohol Drinking/psychology ; Humans ; Treatment Outcome
Abstract: Rationale: The alcohol cue exposure paradigm is a common method for evaluating new treatments for alcohol use disorder (AUD); however, it is unclear if medication-related reductions in cue-induced craving in the human laboratory can predict the clinical success of those medications in reducing alcohol consumption during clinical trials.
Objectives: To use a novel meta-analytic approach to test whether medication effect sizes on cue-induced alcohol craving are associated with clinical efficacy in clinical trials.
Method: We searched the literature for medications tested for AUD treatment using both the alcohol cue-reactivity paradigm and randomized clinical trials (RCTs). For alcohol cue-reactivity studies, we computed medication effect sizes for cue-induced alcohol craving (k = 36 studies, 15 medications). For RCTs, we calculated medication effect sizes for heavy drinking and abstinence (k = 139 studies, 19 medications). Using medication as the unit of analysis, we applied the Williamson-York bivariate weighted least squares estimation to account for errors in both independent and dependent variables. We also conducted leave-one-out cross validation simulations to examine the predictive utility of cue-craving medication effect sizes on RCT heavy drinking and abstinence endpoints.
Results: There was no significant relationship between medication effects on cue-induced alcohol craving in the human laboratory and medication effects on heavy drinking ( INLINEMATH = 0.253, SE = 0.189, p = 0.090) and abstinence ( INLINEMATH = 0.829, SE = 0.747, p = 0.133) in RCTs.
Conclusions: The preliminary results of the current study challenge the assumption that alcohol cue-reactivity alone can be used as an early efficacy indicator for AUD pharmacotherapy development. These findings suggest that a wider range of early efficacy indicators and experimental paradigms be considered for Phase II testing of novel compounds.
(© 2024. The Author(s).)
References: Control Clin Trials. 1986 Sep;7(3):177-88. (PMID: 3802833)
Addict Biol. 2014 Sep;19(5):941-54. (PMID: 23489253)
Alcohol Clin Exp Res. 1999 Aug;23(8):1386-94. (PMID: 10470982)
J Abnorm Psychol. 1987 May;96(2):122-6. (PMID: 3584660)
Curr Top Behav Neurosci. 2016;28:151-71. (PMID: 27240677)
Curr Pharm Des. 2010;16(19):2149-58. (PMID: 20482505)
Alcohol Clin Exp Res. 2012 Feb;36(2):351-60. (PMID: 21919922)
Alcohol Clin Exp Res (Hoboken). 2023 Sep;47(9):1629-1645. (PMID: 37423771)
Psychopharmacology (Berl). 2023 Sep;240(9):1921-1930. (PMID: 37452887)
Neuropsychopharmacology. 2021 Feb;46(3):519-527. (PMID: 33235284)
Psychopharmacology (Berl). 2011 Oct;217(3):341-51. (PMID: 21487653)
Psychopharmacology (Berl). 2017 Sep;234(18):2737-2745. (PMID: 28600734)
Psychopharmacology (Berl). 2002 Feb;160(1):19-29. (PMID: 11862370)
Psychopharmacology (Berl). 2001 Apr;155(1):27-34. (PMID: 11374333)
Handb Exp Pharmacol. 2018;248:537-578. (PMID: 29374834)
Alcohol Clin Exp Res. 2020 Jan;44(1):23-35. (PMID: 31803968)
Addict Biol. 2017 May;22(3):581-615. (PMID: 26833803)
Perspect Psychol Sci. 2016 Sep;11(5):713-729. (PMID: 27694466)
Am J Psychiatry. 2003 Jul;160(7):1320-5. (PMID: 12832248)
Addiction. 1999 Mar;94(3):327-40. (PMID: 10605857)
Alcohol Clin Exp Res. 2020 Jul;44(7):1431-1443. (PMID: 32363592)
Alcohol Clin Exp Res. 2012 Jun;36(6):972-83. (PMID: 22309888)
Psychon Bull Rev. 2026 Feb 27;33(3):. (PMID: 41760983)
J Consult Clin Psychol. 2013 Feb;81(1):13-22. (PMID: 23231573)
Psychopharmacology (Berl). 2009 Jul;205(1):53-62. (PMID: 19319508)
J Addict Med. 2022 Nov-Dec 01;16(6):630-638. (PMID: 35653782)
Alcohol Clin Exp Res. 2014 Jan;38(1):27-32. (PMID: 23889161)
Addict Biol. 2012 May;17(3):513-27. (PMID: 22458728)
J Subst Abuse Treat. 2022 Jul;138:108749. (PMID: 35216868)
Grant Information: F31AA029295 United States AA NIAAA NIH HHS; F32 AA029288 United States AA NIAAA NIH HHS; F32AA029288 United States AA NIAAA NIH HHS; R21 AA029771 United States AA NIAAA NIH HHS; K24 AA025704 United States AA NIAAA NIH HHS; R21AA029771 United States AA NIAAA NIH HHS; F31 AA029295 United States AA NIAAA NIH HHS; K24AA025704 United States AA NIAAA NIH HHS
Contributed Indexing: Keywords: Alcohol cue-reactivity; Alcohol use disorder; Cue-induced craving; Human laboratory; Medication development; Randomized clinical trials
Entry Date(s): Date Created: 20240413 Date Completed: 20240724 Latest Revision: 20260924
Update Code: 20260924
PubMed Central ID: PMC11269462
DOI: 10.1007/s00213-024-06589-7
PMID: 38613685
Database: MEDLINE
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  – Url: https://dx.doi.org/doi:10.1007/s00213-024-06589-7
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  Data: Leveraging meta-regression to test if medication effects on cue-induced craving are associated with clinical efficacy.
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  Data: <searchLink fieldCode="AU" term="%22Nieto+SJ%22">Nieto SJ</searchLink>; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA. snieto@psych.ucla.edu.<br /><searchLink fieldCode="AU" term="%22Du+H%22">Du H</searchLink>; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.<br /><searchLink fieldCode="AU" term="%22Meredith+LR%22">Meredith LR</searchLink>; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.<br /><searchLink fieldCode="AU" term="%22Donato+S%22">Donato S</searchLink>; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.<br /><searchLink fieldCode="AU" term="%22Magill+M%22">Magill M</searchLink>; Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, Rhode Island, USA.<br /><searchLink fieldCode="AU" term="%22Ray+LA%22">Ray LA</searchLink>; Department of Psychology, University of California at Los Angeles, 1285 Franz Hall, Box 951563, Los Angeles, CA, 90095-1563, USA.; Department of Psychiatry and Biobehavioral Sciences, University of California at Los Angeles, Los Angeles, CA, USA.
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  Data: <searchLink fieldCode="JN" term="%227608025%22">Psychopharmacology</searchLink> [Psychopharmacology (Berl)] 2024 Aug; Vol. 241 (8), pp. 1679-1689. <i>Date of Electronic Publication: </i>2024 Apr 13.
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  Data: <searchLink fieldCode="MM" term="%22Craving%22">Craving*</searchLink>/<searchLink fieldCode="MM" term="%22Craving+drug+effects%22">drug effects</searchLink> <br /><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+psychology%22">psychology</searchLink> <br /><searchLink fieldCode="MM" term="%22Cues%22">Cues*</searchLink> <br /><searchLink fieldCode="MM" term="%22Randomized+Controlled+Trials+as+Topic%22">Randomized Controlled Trials as Topic*</searchLink><br /><searchLink fieldCode="MH" term="%22Alcohol+Drinking%22">Alcohol Drinking</searchLink>/<searchLink fieldCode="MH" term="%22Alcohol+Drinking+psychology%22">psychology</searchLink> ; <searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Treatment+Outcome%22">Treatment Outcome</searchLink>
– Name: Abstract
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  Data: Rationale: The alcohol cue exposure paradigm is a common method for evaluating new treatments for alcohol use disorder (AUD); however, it is unclear if medication-related reductions in cue-induced craving in the human laboratory can predict the clinical success of those medications in reducing alcohol consumption during clinical trials.<br />Objectives: To use a novel meta-analytic approach to test whether medication effect sizes on cue-induced alcohol craving are associated with clinical efficacy in clinical trials.<br />Method: We searched the literature for medications tested for AUD treatment using both the alcohol cue-reactivity paradigm and randomized clinical trials (RCTs). For alcohol cue-reactivity studies, we computed medication effect sizes for cue-induced alcohol craving (k = 36 studies, 15 medications). For RCTs, we calculated medication effect sizes for heavy drinking and abstinence (k = 139 studies, 19 medications). Using medication as the unit of analysis, we applied the Williamson-York bivariate weighted least squares estimation to account for errors in both independent and dependent variables. We also conducted leave-one-out cross validation simulations to examine the predictive utility of cue-craving medication effect sizes on RCT heavy drinking and abstinence endpoints.<br />Results: There was no significant relationship between medication effects on cue-induced alcohol craving in the human laboratory and medication effects on heavy drinking ( INLINEMATH = 0.253, SE = 0.189, p = 0.090) and abstinence ( INLINEMATH = 0.829, SE = 0.747, p = 0.133) in RCTs.<br />Conclusions: The preliminary results of the current study challenge the assumption that alcohol cue-reactivity alone can be used as an early efficacy indicator for AUD pharmacotherapy development. These findings suggest that a wider range of early efficacy indicators and experimental paradigms be considered for Phase II testing of novel compounds.<br /> (© 2024. The Author(s).)
– Name: Ref
  Label: References
  Group: RefInfo
  Data: Control Clin Trials. 1986 Sep;7(3):177-88. (PMID: <searchLink fieldCode="PM" term="%223802833%22">3802833)</searchLink><br />Addict Biol. 2014 Sep;19(5):941-54. (PMID: <searchLink fieldCode="PM" term="%2223489253%22">23489253)</searchLink><br />Alcohol Clin Exp Res. 1999 Aug;23(8):1386-94. (PMID: <searchLink fieldCode="PM" term="%2210470982%22">10470982)</searchLink><br />J Abnorm Psychol. 1987 May;96(2):122-6. (PMID: <searchLink fieldCode="PM" term="%223584660%22">3584660)</searchLink><br />Curr Top Behav Neurosci. 2016;28:151-71. (PMID: <searchLink fieldCode="PM" term="%2227240677%22">27240677)</searchLink><br />Curr Pharm Des. 2010;16(19):2149-58. (PMID: <searchLink fieldCode="PM" term="%2220482505%22">20482505)</searchLink><br />Alcohol Clin Exp Res. 2012 Feb;36(2):351-60. (PMID: <searchLink fieldCode="PM" term="%2221919922%22">21919922)</searchLink><br />Alcohol Clin Exp Res (Hoboken). 2023 Sep;47(9):1629-1645. (PMID: <searchLink fieldCode="PM" term="%2237423771%22">37423771)</searchLink><br />Psychopharmacology (Berl). 2023 Sep;240(9):1921-1930. (PMID: <searchLink fieldCode="PM" term="%2237452887%22">37452887)</searchLink><br />Neuropsychopharmacology. 2021 Feb;46(3):519-527. (PMID: <searchLink fieldCode="PM" term="%2233235284%22">33235284)</searchLink><br />Psychopharmacology (Berl). 2011 Oct;217(3):341-51. (PMID: <searchLink fieldCode="PM" term="%2221487653%22">21487653)</searchLink><br />Psychopharmacology (Berl). 2017 Sep;234(18):2737-2745. (PMID: <searchLink fieldCode="PM" term="%2228600734%22">28600734)</searchLink><br />Psychopharmacology (Berl). 2002 Feb;160(1):19-29. (PMID: <searchLink fieldCode="PM" term="%2211862370%22">11862370)</searchLink><br />Psychopharmacology (Berl). 2001 Apr;155(1):27-34. (PMID: <searchLink fieldCode="PM" term="%2211374333%22">11374333)</searchLink><br />Handb Exp Pharmacol. 2018;248:537-578. (PMID: <searchLink fieldCode="PM" term="%2229374834%22">29374834)</searchLink><br />Alcohol Clin Exp Res. 2020 Jan;44(1):23-35. (PMID: <searchLink fieldCode="PM" term="%2231803968%22">31803968)</searchLink><br />Addict Biol. 2017 May;22(3):581-615. (PMID: <searchLink fieldCode="PM" term="%2226833803%22">26833803)</searchLink><br />Perspect Psychol Sci. 2016 Sep;11(5):713-729. (PMID: <searchLink fieldCode="PM" term="%2227694466%22">27694466)</searchLink><br />Am J Psychiatry. 2003 Jul;160(7):1320-5. (PMID: <searchLink fieldCode="PM" term="%2212832248%22">12832248)</searchLink><br />Addiction. 1999 Mar;94(3):327-40. (PMID: <searchLink fieldCode="PM" term="%2210605857%22">10605857)</searchLink><br />Alcohol Clin Exp Res. 2020 Jul;44(7):1431-1443. (PMID: <searchLink fieldCode="PM" term="%2232363592%22">32363592)</searchLink><br />Alcohol Clin Exp Res. 2012 Jun;36(6):972-83. (PMID: <searchLink fieldCode="PM" term="%2222309888%22">22309888)</searchLink><br />Psychon Bull Rev. 2026 Feb 27;33(3):. (PMID: <searchLink fieldCode="PM" term="%2241760983%22">41760983)</searchLink><br />J Consult Clin Psychol. 2013 Feb;81(1):13-22. (PMID: <searchLink fieldCode="PM" term="%2223231573%22">23231573)</searchLink><br />Psychopharmacology (Berl). 2009 Jul;205(1):53-62. (PMID: <searchLink fieldCode="PM" term="%2219319508%22">19319508)</searchLink><br />J Addict Med. 2022 Nov-Dec 01;16(6):630-638. (PMID: <searchLink fieldCode="PM" term="%2235653782%22">35653782)</searchLink><br />Alcohol Clin Exp Res. 2014 Jan;38(1):27-32. (PMID: <searchLink fieldCode="PM" term="%2223889161%22">23889161)</searchLink><br />Addict Biol. 2012 May;17(3):513-27. (PMID: <searchLink fieldCode="PM" term="%2222458728%22">22458728)</searchLink><br />J Subst Abuse Treat. 2022 Jul;138:108749. (PMID: <searchLink fieldCode="PM" term="%2235216868%22">35216868)</searchLink>
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