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Could a Low-Dose drug ease POTS fatigue? new trial aims to find out

NCT ID NCT05363514

Symptom relief Sponsor: University of Calgary Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether low dose naltrexone (LDN) can reduce fatigue in people with Postural Orthostatic Tachycardia Syndrome (POTS). Eighty participants will receive either LDN or a placebo for 4 months. The goal is to see if LDN improves fatigue and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
low dose naltrexone (LDN)
What this could lead to
If it works, this could point toward a new treatment for fatigue in POTS patients, improving their daily quality of life.
What could go wrong
This is a small pilot study, so results may not be conclusive. The drug may not reduce fatigue more than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Physician diagnosis of POTS as defined by the American Autonomic Society consensus statement * Ability to attend research lab in Calgary, Vancouver or Hamilton, Canada * Not pregnant and not planning to become pregnant for the duration of the study * Maintain current other medications at regular doses for the duration of the study Exclusion Criteria: * Overt cause for postural tachycardia (e.g. acute dehydration, hyperthyroidism) * Positive pregnancy test * Breastfeeding * Other factors which in the investigator's opinion would prevent participant from completing the protocol, including poor compliance during previous studies * Current use of Low Dose Naltrexone * Use of opioid containing medications or positive urine opioid test * History of alcohol, opioid or other substance use disorder

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Conditions

The condition(s) this trial relates to.

postural orthostatic tachycardia syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postural orthostatic tachycardia syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.