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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000131459

Acronym

ThyroLDN

Enrollment

126

Registered

2025-02-06

Start date

2025-09-01

Completion date

2026-10-01

Last updated

2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- Age greater of equal to 18-years. - Greater than 3 months since diagnosis of Hashimoto’s disease. - Stable thyroxine dose for greater or equal to 3 months. - Thyroid stimulating hormone (TSH) level within normal range. - Dissatisfaction with thyroxine treatment. - Patient-perceived residual hypothyroid symptoms. - Ability to provide written informed consent and adhere to the study protocol.

Exclusion criteria

- Documented allergy to naltrexone. - Opioid dependence or inability to abstain from opioids during the study. - Recent modification (within 3-months) of diet, lifestyle or medication known to impact weight, blood pressure, thyroid function or other important study outcome measures. - Pregnancy or planning pregnancy.

Outcome results