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Reductions in World Health Organization Risk Drinking Levels as a Primary Efficacy End Point for Alcohol Clinical
Katie Witkiewitz1,2, Raymond F Anton3, Stephanie S O'Malley4
1Center on Alcohol, Substance use, And Addictions (CASAA), University of New Mexico, Albuquerque.
JAMA Psychiatry
|September 17, 2025
Summary
Reducing alcohol consumption, measured by World Health Organization Risk Drinking Levels (WHO RDLs), improves patient well-being and functioning. This approach supports harm reduction for Alcohol Use Disorder (AUD) treatment.
Area of Science:
- Addiction Medicine
- Psychiatry
- Public Health
Background:
- Alcohol Use Disorder (AUD) is a prevalent and costly condition.
- Abstinence is often the treatment goal, but many with AUD do not seek treatment due to this goal.
- The FDA now accepts drinking reductions as a clinical trial endpoint.
Purpose of the Study:
- To review literature on World Health Organization Risk Drinking Levels (WHO RDLs) as a marker for patient-reported outcomes in AUD.
- To assess the utility of WHO RDLs in clinical trials and practice.
Main Methods:
- A narrative review of 34 articles was conducted.
- Articles examined WHO RDLs as a surrogate marker for how individuals with AUD feel and function.
Main Results:
- Drinking reductions correlate with improved patient well-being, functioning, and quality of life.
- Reductions are associated with decreased risks of substance use disorder, medical/psychiatric diseases, and alcohol-related consequences.
- Effect sizes for WHO RDL reductions in clinical trials are comparable or superior to other endpoints.
Conclusions:
- FDA acceptance of WHO RDLs as an endpoint may advance AUD medication development and encourage harm reduction treatment.
- WHO RDLs can guide targeted drinking reduction strategies in clinical practice.
- This facilitates a paradigm shift towards harm reduction in AUD management.
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