Reductions in World Health Organization Risk Drinking Levels as a Primary Efficacy End Point for Alcohol Clinical Trials

The FDA acceptance of reduction in WHO RDLs as a primary end point for alcohol clinical trials may increase opportunities for AUD medications development, encourage patients to seek treatments that target drinking reductions, and engage clinicians in prescribing medications shown to be effective in supporting drinking reductions. The WHO RDLs may be particularly useful for targeted drinking reductions in clinical practice. Qualification of the WHO RDL end point facilitates a paradigm shift toward a harm reduction approach in AUD treatment.

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Publication Details

Journal
JAMA Psychiatry
Published
2025-09-17
DOI
https://doi.org/10.1001/jamapsychiatry.2025.2508
Citations
8
Primary Topic
Substance Abuse Treatment and Outcomes
Type
article
Field-Weighted Citation Impact
10.83
Controls
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article

Reductions in World Health Organization Risk Drinking Levels as a Primary Efficacy End Point for Alcohol Clinical Trials

Conrad J. Wong, Katie A. Witkiewitz, Deborah S. Hasin, Arnie Aldridge et al.
8 citations
JAMA Psychiatry
Substance Abuse Treatment and Outcomes
10.83
article

Reductions in World Health Organization Risk Drinking Levels as a Primary Efficacy End Point for Alcohol Clinical Trials

Conrad J. Wong, Katie A. Witkiewitz, Deborah S. Hasin, Arnie Aldridge, Henri‐Jean Aubin, Stephanie S. O’Malley, Michaela Hoffman, Karl Mann, Bernard L. Silverman, Gary A. Zarkin, Raymond F. Anton, Henry R. Kranzler, Didier Meulien
article en
8 citations

Abstract

The FDA acceptance of reduction in WHO RDLs as a primary end point for alcohol clinical trials may increase opportunities for AUD medications development, encourage patients to seek treatments that target drinking reductions, and engage clinicians in prescribing medications shown to be effective in supporting drinking reductions. The WHO RDLs may be particularly useful for targeted drinking reductions in clinical practice. Qualification of the WHO RDL end point facilitates a paradigm shift toward a harm reduction approach in AUD treatment.

JAMA PsychiatryVol. 82(12)
Medical University of South Carolina (US), University of New Mexico (US), Office of Chief Medical Examiner (US), RTI International (US), Heidelberg University (DE), AIDS Clinical Trials Group (US), University Hospital Heidelberg (DE), Yale University (US), Central Institute of Mental Health (DE), National Center on Addiction and Substance Abuse at Columbia University (US), New York State Psychiatric Institute, Columbia University (US)
Openalex Percentile: Top 1%
Substance Abuse Treatment and Outcomes
10.83
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