Low dose naltrexone for treatment of Hashimoto’s thyroiditis — ASN Events
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Low dose naltrexone for treatment of Hashimoto’s thyroiditis (#369)

Christopher A Muir 1
  1. St. Vincent's Hospital, Darlinghurst, NSW, Australia

Aims: Following diagnosis of Hashimoto’s thyroiditis, a substantial proportion of patients continue to experience hypothyroid symptoms despite adequate thyroxine replacement. The ThyroLDN trial (ACTRN12625000131459) tests whether the addition of low dose naltrexone (LDN) to standard thyroid hormone replacement improves quality of life (QoL) in individuals with Hashimoto’s thyroiditis. It was partially funded by the 2024 RACP-ESA Research Establishment Fellowship.

Methods: ThyroLDN is a phase 2, 6-month, randomised, double-blind, placebo-controlled trial of naltrexone 4.5 mg daily compared to placebo in patients with Hashimoto’s disease and persistent hypothyroid symptoms. The primary outcome is mean change in QoL as measured by ThyPRO-39 score (ThyPRO-39 is a 39-item, validated, thyroid-specific, patient reported outcome instrument). Study enrolment commenced in September 2025 and will continue until September 2026. Blinded preliminary data from the trial will be presented, with participant unblinding and full results to be reported after study completion in April 2027.

Results: 127 participants are currently enrolled. Median age of participants is 46-years (range 24-78) and 92% are female. At baseline, prevalent hypothyroid symptoms included fatigue (97%), brain fog (87%), weight issues (82%), myalgia/arthralgia (68%), hair/skin/nail issues (65%), low mood (54%), cold intolerance (53%), and constipation (39%). Most participants (74%) had previously seen an endocrinologist and 55% had previously seen a naturopathic, holistic, or integrative doctor. For those who have already completed the 3-month review, 45 (52%) felt they were receiving LDN and 42 (48%) placebo. Of those who thought they were in the LDN arm, 37 (82%) reported experiencing a clinical benefit and 8 (18%) had ceased due to side effects. 

Conclusion: QoL is reduced for many people with Hashimoto’s thyroiditis. The ThyroLDN trial is testing whether LDN is a useful adjunct to thyroid hormone replacement in the subset of patients with this condition who still experience hypothyroid symptoms.