HMN 2026: How Shorter clinical trials of medication for alcohol use disorder can be as useful or more useful than longer trials

Randomized control trials that are shorter than 12 weeks show similar results to longer trials when assessing a new medication’s effectiveness in helping someone with alcohol use disorder reduce or stop drinking. And in trials where the medication showed significant effects, trials lasting 12 weeks or shorter produced more reliable results than longer trials, according to a meta-analysis of clinical trials published in Alcohol: Clinical and Experimental Research. Currently, the US Food and Drug Administration recommends clinical trials of alcohol use disorder medications last at least six months. The authors of the analysis recommend that regulators and researchers consider shorter duration trials, which reduce burden and risk for trial participants and lower research costs.

Researchers performed a meta-regression to synthesize findings from 139 randomized controlled trials of 19 different alcohol use disorder pharmacotherapies conducted between 1985 and 2023, to determine whether the reported effectiveness of the test medications varied with study duration. They compared effect sizes, that is, the differences in outcomes between medication groups and placebo groups, of trials that lasted 12 weeks to trials that lasted longer or shorter than 12 weeks.

For both abstinence and reduced drinking outcomes, medication showed significantly better outcomes compared to placebo in the 12-week trials, and these results were consistent in trials both shorter and longer than 12 weeks. When analyzing only the effect sizes that were statistically significant and indicated a favorable effect of the medication, the trials longer than 12 weeks showed smaller effect sizes than trials 12 weeks or shorter, suggesting that the longer duration may make the trials susceptible to factors that can compromise the data, such as participants dropping out or not consistently taking medication.

Shorter clinical trials are less expensive and less burdensome for study participants, particularly those not benefitting from the test medication, who could obtain effective treatment for their alcohol use disorder sooner. The authors recommend that regulatory guidance and research design weigh these factors and their findings that shorter studies produce results equivalent to those of longer studies.

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