RecruitingPhase 2ACTRN12625000131459

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.


Sponsor

St. Vincent's Hospital, Sydney

Enrollment

150 participants

Start Date

Sep 1, 2025

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Hypothyroidism — an underactive thyroid — is usually treated with thyroxine tablets that replace the missing hormone. But many people still feel unwell even when their blood tests look perfectly normal. They may experience fatigue, brain fog, weight problems, or low mood. Currently, there are no other approved medications specifically for this situation. This study is testing whether a low dose of naltrexone — a medication normally used for alcohol and opioid dependence — can help people with Hashimoto's-related hypothyroidism feel better when added to their usual thyroxine treatment. Participants will receive either naltrexone or an identical-looking placebo tablet and will be assessed for improvements in quality of life, symptoms, and various health measures over the course of the study. You may be eligible if you are 18 or older, have been diagnosed with Hashimoto's disease for more than 3 months, have been on a stable thyroxine dose for at least 3 months, and still feel that your treatment isn't working well enough. People who are pregnant, planning pregnancy, have an opioid dependency, or have recently changed their diet or other medications are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Naltrexone 4.5 mg oral capsule daily for 6-months. Adherence will be assessed by drug tablet return

Naltrexone 4.5 mg oral capsule daily for 6-months. Adherence will be assessed by drug tablet return


Locations(1)

NSW, Australia

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ACTRN12625000131459


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