A Pilot Study of Low Dose Naltrexone Use in Patients With Postural Orthostatic Tachycardia Syndrome

REB22-0565

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.

2025-01-01

2028-06-01

2028-12-01

Not yet recruiting

Early phase I

80

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Study drug and placebo will be masked by the pharmacy.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

2024-05-09