Low Dose Naltrexone Use in Patients With POTS
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Calgary
About this trial
Many patients with Postural Orthostatic Tachycardia Syndrome (POTS) experience debilitating fatigue and this significantly impacts their daily lives. Unfortunately, there are no treatments to help POTS patients with their fatigue. One medication, called low dose naltrexone (LDN), has been tested as a treatment for fatigue in other medical conditions. In this other research, LDN helped patients feel less fatigue. Other research studies have shown that LDN can help reduce markers of inflammation called cytokines. Reducing these cytokines could help reduce symptoms as well. There have been no research studies testing LDN in POTS to date. We are planning to do a research study to test LDN as a treatment to see if it helps POTS patients feel less fatigue.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Low Dose Naltrexone
- Microcrystalline cellulose
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov