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

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 alcoh...

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Publicado en:Psychopharmacology Vol. 241; no. 8; pp. 1679 - 1690
Autores principales: Nieto, Steven J., Du, Han, Meredith, Lindsay R., Donato, Suzanna, Magill, Molly, Ray, Lara A.
Formato: Journal Article
Publicado: Springer Nature Aug2024
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Aug2024
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00213-024-06589-7
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        atl: Leveraging meta-regression to test if medication effects on cue-induced craving are associated with clinical efficacy.
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        au:
          Nieto, Steven J.
          Du, Han
          Meredith, Lindsay R.
          Donato, Suzanna
          Magill, Molly
          Ray, Lara A.
        affil: https://ror.org/046rm7j60 Department of Psychology, University of California at Los Angeles, Box 951563, 1285 Franz Hall, 90095-1563, Los Angeles, CA, USA
      sug:
      ab: 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 ( β ^ = 0.253, SE = 0.189, p = 0.090) and abstinence ( β ^ = 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.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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