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Medication development for AUD: A systematic review of clinical trial methodology.

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Τίτλος: Medication development for AUD: A systematic review of clinical trial methodology.
Συγγραφείς: Donato S; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA., Meredith LR; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA., Nieto SJ; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA., Bujarski S; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA., Ray LA; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Brain Research Institute, University of California, Los Angeles, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: lararay@psych.ucla.edu.
Πηγή: Alcohol (Fayetteville, N.Y.) [Alcohol] 2024 Nov; Vol. 120, pp. 194-203. Date of Electronic Publication: 2024 Jul 05.
Τύπος έκδοσης: Journal Article; Systematic Review; Research Support, N.I.H., Extramural
Γλώσσα: English
Στοιχεία περιοδικού: Publisher: Elsevier Science Country of Publication: United States NLM ID: 8502311 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-6823 (Electronic) Linking ISSN: 07418329 NLM ISO Abbreviation: Alcohol Subsets: MEDLINE
Imprint Name(s): Publication: New York Ny : Elsevier Science
Original Publication: Fayetteville, N.Y. : Ankho International, c1984-
Ιατρικοί όροι (MeSH): Randomized Controlled Trials as Topic*/methods , Alcoholism*/drug therapy, Alcohol Deterrents/therapeutic use ; Drug Development/methods ; Naltrexone/therapeutic use ; Humans ; Research Design
Περίληψη: Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k = 42), acamprosate (k = 24), and baclofen (k = 11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR = 12-16; min = 4 max = 52) and the median follow-up duration was 12.5 weeks (IQR: 12-26; min = 7 max = 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k = 87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.
(Copyright © 2024. Published by Elsevier Inc.)
Competing Interests: Declaration of competing interest None.
Grant Information: R21 AA029771 United States AA NIAAA NIH HHS; F31 AA029295 United States AA NIAAA NIH HHS; F32 AA029288 United States AA NIAAA NIH HHS; K24 AA025704 United States AA NIAAA NIH HHS
Contributed Indexing: Keywords: Alcohol use disorder; Medications development; Pharmacotherapy; Randomized clinical trials
Substance Nomenclature: 0 (Alcohol Deterrents)
5S6W795CQM (Naltrexone)
Entry Date(s): Date Created: 20240707 Date Completed: 20240911 Latest Revision: 20260409
Update Code: 20260410
DOI: 10.1016/j.alcohol.2024.06.007
PMID: 38972367
Βάση Δεδομένων: MEDLINE
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  Data: <searchLink fieldCode="AU" term="%22Donato+S%22">Donato S</searchLink>; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Meredith+LR%22">Meredith LR</searchLink>; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Nieto+SJ%22">Nieto SJ</searchLink>; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Bujarski+S%22">Bujarski S</searchLink>; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.<br /><searchLink fieldCode="AU" term="%22Ray+LA%22">Ray LA</searchLink>; Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Brain Research Institute, University of California, Los Angeles, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: lararay@psych.ucla.edu.
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  Data: <searchLink fieldCode="JN" term="%228502311%22">Alcohol (Fayetteville, N.Y.)</searchLink> [Alcohol] 2024 Nov; Vol. 120, pp. 194-203. <i>Date of Electronic Publication: </i>2024 Jul 05.
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  Data: Refining clinical trial methodology has become increasingly important as study design is shown to influence treatment efficacy. To maximize the efficiency of randomized clinical trials (RCTs), researchers aim to establish standardized practices. The goal of this systematic review is to describe methodological practices of clinical trials for alcohol use disorder (AUD) over the past 40 years. To achieve this goal, a PubMed search was conducted in April 2023 for RCTs on AUD medications published between July 2018 through April 2023. Resulting studies were combined with a previous search from 1985 through 2018. Inclusion criteria for the RCT studies were: (1) a randomized controlled trial, (2) double or single blinded, (3) placebo or active control condition, (4) alcohol use as the primary endpoint, (5) 4 or more weeks of treatment, and (6) 12 or more weeks of follow-up. In total, methodological data from 139 RCTs representing 19 medications and spanning the past four decades were summarized. Results indicated that the most common medications tested were naltrexone (k = 42), acamprosate (k = 24), and baclofen (k = 11). On average, participants were 74% male and consumed 226 drinks per month pre-randomization. The median length of treatment was 12 weeks (IQR = 12-16; min = 4 max = 52) and the median follow-up duration was 12.5 weeks (IQR: 12-26; min = 7 max = 104). There were two broad domains of outcomes (i.e., abstinence and heavy drinking), with most studies featuring outcomes from both domains (k = 87; 63%). Reporting practices were summarized by decade, revealing an increased enrollment of females, better reporting of race and ethnicity data, and less studies requiring pre-trial abstinence. This review summarizes the current state of the literature on randomized clinical trials for AUD including effect sizes for individual studies and summaries of key methodological features across this representative set of clinical trials.<br /> (Copyright © 2024. Published by Elsevier Inc.)
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  Data: Declaration of competing interest None.
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  Data: R21 AA029771 United States AA NIAAA NIH HHS; F31 AA029295 United States AA NIAAA NIH HHS; F32 AA029288 United States AA NIAAA NIH HHS; K24 AA025704 United States AA NIAAA NIH HHS
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