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
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
Fill out the following form if you want to participate in this research
Collection of personal information
Your personal information is collected under
the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If
you have any questions about the collection or use of this information, please visit our
Access to Information page.
Additional information
Contact information
Rasha Hamzeh, Research Coordinator
Principal investigator:
Satish Raj
Clinical trial:
Yes
REB-ID:
REB22-0565
External links