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Trial registered on ANZCTR


Registration number
ACTRN12625000131459
Ethics application status
Approved
Date submitted
1/02/2024
Date registered
6/02/2025
Date last updated
6/02/2025
Date data sharing statement initially provided
6/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does treatment with naltrexone (a medication) improve quality of life in patients with hypothyroidism (underactive thyroid)?
Scientific title
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.
Secondary ID [1] 311444 0
None
Universal Trial Number (UTN)
Trial acronym
ThyroLDN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hashimoto's disease 332746 0
Hypothyroidism 332747 0
Condition category
Condition code
Metabolic and Endocrine 329468 329468 0 0
Thyroid disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Naltrexone 4.5 mg oral capsule daily for 6-months. Adherence will be assessed by drug tablet return
Intervention code [1] 327897 0
Treatment: Drugs
Comparator / control treatment
Placebo - size 0 Swedish orange capsule containing microcrystalline cellulose USP/EP capsules
Control group
Placebo

Outcomes
Primary outcome [1] 337280 0
Change in thyroid specific quality of life
Timepoint [1] 337280 0
The primary outcome measure will be change from baseline assessed at 6-months post commencement of treatment. Additional secondary timepoints will include 3 months post commencement of treatment.
Secondary outcome [1] 431308 0
Change in weight (BMI).
Timepoint [1] 431308 0
Weight and BMI will be assessed at baseline, and a 3- and 6-months post commencement of treatment.
Secondary outcome [2] 431309 0
Change in lipid profile.
Timepoint [2] 431309 0
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides (mmol/L) will be assessed at baseline, and 6-months post commencement of treatment.
Secondary outcome [3] 431310 0
Change in thyroid autoimmunity.
Timepoint [3] 431310 0
Thyroid peroxidase antibody titre will be assessed at baseline, and a 3- and 6-months post commencement of treatment.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Documented allergy to naltrexone.
- Opioid dependence or inability to abstain from opioids during the study.
- Thyroid hormone replacement with anything other than thyroxine monotherapy.
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Yes, unstratified simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
1/06/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315722 0
Charities/Societies/Foundations
Name [1] 315722 0
St. Vincent's Clinic Foundation
Country [1] 315722 0
Australia
Funding source category [2] 318296 0
Charities/Societies/Foundations
Name [2] 318296 0
RACP ESA Research Establishment Fellowship
Country [2] 318296 0
Australia
Primary sponsor type
Hospital
Name
St. Vincent's Hospital, Sydney
Address
Country
Australia
Secondary sponsor category [1] 320680 0
None
Name [1] 320680 0
Address [1] 320680 0
Country [1] 320680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314585 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 314585 0
https://svhs.org.au/home/research-education/research-office
Ethics committee country [1] 314585 0
Australia
Date submitted for ethics approval [1] 314585 0
04/11/2023
Approval date [1] 314585 0
31/01/2024
Ethics approval number [1] 314585 0
2023/ETH02549

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132094 0
Dr Christopher Alan Muir
Address 132094 0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Country 132094 0
Australia
Phone 132094 0
+61 4 5013 3265
Fax 132094 0
Email 132094 0
[email protected]
Contact person for public queries
Name 132095 0
Christopher Alan Muir
Address 132095 0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Country 132095 0
Australia
Phone 132095 0
+61 2 8382 2622
Fax 132095 0
Email 132095 0
[email protected]
Contact person for scientific queries
Name 132096 0
Christopher Alan Muir
Address 132096 0
Department of Endocrinology, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, NSW 2010
Country 132096 0
Australia
Phone 132096 0
+61 2 8382 2622
Fax 132096 0
Email 132096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.