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

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος: Leveraging meta-regression to test if medication effects on cue-induced craving are associated with clinical efficacy.
Συγγραφείς: 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.
Πηγή: Psychopharmacology [Psychopharmacology (Berl)] 2024 Aug; Vol. 241 (8), pp. 1679-1689. Date of Electronic Publication: 2024 Apr 13.
Τύπος έκδοσης: Journal Article; Meta-Analysis
Γλώσσα: English
Στοιχεία περιοδικού: 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.
Ιατρικοί όροι (MeSH): Craving*/drug effects , Alcoholism*/drug therapy , Alcoholism*/psychology , Cues* , Randomized Controlled Trials as Topic*, Alcohol Drinking/psychology ; Humans ; Treatment Outcome
Περίληψη: 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).)
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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
Βάση Δεδομένων: MEDLINE
Περιγραφή
ISSN:1432-2072
DOI:10.1007/s00213-024-06589-7