Status:
NOT_YET_RECRUITING
Low Dose Naltrexone Use in Patients With POTS
Lead Sponsor:
University of Calgary
Conditions:
Postural Orthostatic Tachycardia Syndrome
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
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 POT...
Detailed Description
Research Objectives: To evaluate LDN as a treatment for fatigue in patients diagnosed with POTS. The primary hypothesis is that LDN will reduce fatigue in patients with POTS when compared to placebo u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05363514
Start Date
January 1 2025
End Date
December 1 2028
Last Update
May 9 2024
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