Does treatment with naltrexone (a medication) improve quality of life in patients with hypothyroidism (underactive thyroid)?
ThyroLDN: a phase 2, double blind, randomised controlled trial of low dose naltrexone on thyroid-specific quality of life in Hashimoto’s thyroiditis patients with residual hypothyroid symptoms despite optimal thyroid hormone replacement.
St. Vincent's Hospital, Sydney
150 participants
Sep 1, 2025
Interventional
Conditions
Summary
Many people with hypothyroidism do not feel well, even when their blood tests say their thyroid levels are normal. Apart from thyroxine, there are no other approved medications available to treat hypothyroidism. Naltrexone, a medication typically used to treat other conditions, may help people with hypothyroidism feel better when taken at a low dose. The purpose of this study is to determine whether naltrexone is beneficial when used in addition to thyroxine for the treatment of hypothyroidism. Our proposed study will test if naltrexone improves quality of life and other health related measures versus a placebo tablet. This will help us to understand whether this medication (naltrexone) should be studied further as a potential treatment for hypothyroidism. Medications must be approved for use by the Australian Federal Government. Naltrexone is currently approved in Australia to treat alcohol and opioid dependence. However, it is not approved to treat hypothyroidism. Therefore, it is an experimental medication for treatment of hypothyroidism secondary to Hashimoto’s thyroiditis. This means that it must be tested to see if it is effective for this indication.
Eligibility
Plain Language Summary
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Interventions
Naltrexone 4.5 mg oral capsule daily for 6-months. Adherence will be assessed by drug tablet return
Locations(1)
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ACTRN12625000131459