ArticleContemporary clinical trials2025
Development of a pharmacodynamic biomarker of opioid antagonism in adolescents with eating disorders: Study protocol for the naltrexone neuroimaging randomized controlled trial (NN-RCT).
Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Considerations for informing precision psychiatry in eating disorders: Foundations for future practice.Journal of eating disorders · 2025Article
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Authors and funding
14 authors.
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Abstract
Eating disorders (ED) affect 5 % of youth, are associated with reward system alterations, and lead to substantial morbidity. Naltrexone, an opioid antagonist, is used to treat ED behaviors such as binge eating and purging. However, not all patients respond, and the optimal dose is unknown. Neuroimaging may serve as a tool to detect drug response in the brain, acting as a pharmacodynamic biomarker to support therapeutic optimization. Currently, no pharmacodynamic biomarkers for psychopharmacology exist. Building on pilot work, we present the protocol for a randomized controlled trial to validate neuroimaging as a pharmacodynamic biomarker of opioid antagonism in adolescents with ED. Youth aged 13-21 years with binge/purge ED are randomized to receive a single dose of oral naltrexone and placebo in a double-blind using a crossover design with an interdose interval ≥ 2 weeks. Task-based functional neuroimaging detects reward pathway modulation 2 h post-dose. Blood and urine are collected over a model-informed time course. Response (primary outcome) is defined as naltrexone-related blood oxygenation-level dependent signal change (Δ%BOLD) in a priori reward regions of interest and secondary exposure outcomes are naltrexone C
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