Low-Dose Naltrexone (LDN) Use in POTS

Summary

This study will look at using low dose naltrexone (LDN) to reduce fatigue in patients with POTS. Participants will be randomly assigned to either LDN or placebo (cellulose) for a total of 4 months. Participants will not know if they are taking LDN or placebo (blinded study).

Participants will take the blinded medication (LDN or placebo) every day. Participants will be provided with a diary to record symptoms. There are two in-person visits at the University of Calgary Autonomic Research Lab. One visit before participants start taking the study medication (LDN or placebo), and one at the end of the 4-month study period.

During the in-person study visits we will measure heart rate and blood pressure sitting and standing. We will also draw a blood sample. These visits should take about 1 hour each. Throughout the study, we will send some electronic surveys through our secure servers. These surveys will be completed at home and include questions about autonomic symptoms, fatigue, pain and sleep.

Eligibility

Currently recruiting participants: Yes

Eligible gender: Male, Female, Transgender, Other

Eligible ages: 18 to 50

Inclusion criteria:

1. Physician-diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS)
2. Age 18-50 years
3. Able to attend Calgary research lab in person
4. Not pregnant or planning pregnancy
5. Maintain current medications at regular doses for the duration of the study

Exclusion criteria:

1. Does not have a physician-diagnosis of POTS
2. Current LDN use
3. Current opioid-containing medication use
3. Pregnant
4. Breastfeeding
5. History of substance use disorder

Participate

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Method of contact

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Additional information

Contact information

Rasha Hamzeh, Research Coordinator

Principal investigator:

Satish Raj

Clinical trial:

Yes

REB-ID:

REB22-0565