Low Dose Naltrexone Use in Patients With POTS

NCT05363514 | Not Yet Recruiting Phase 4

• 1 other identifier: REB22-0565
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

POTS; LDN; Low Dose Naltrexone

Outcome Measures

Primary Outcomes (1)

• Fatigue Visual Analogue Scale (VAS)

  Change in Fatigue VAS from pre-treatment (baseline) to treatment (4 months). The score is measured from 0-100 (0 is no fatigue).

  4 months

Secondary Outcomes (2)

• RAND 36 Health Related Quality of Life Score

  4 months

• Cytokines

  4 months

Study Arms (2)

Low Dose Naltrexone

EXPERIMENTAL

Low Dose Naltrexone 4.5mg OD PO. Capsules are masked and provided in blister packs.

Drug: Low Dose Naltrexone

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose 4.5mg OD PO. Capsules are masked and provided in blister packs.

Drug: Microcrystalline cellulose

Interventions

Low Dose Naltrexone DRUG

Participant takes Low Dose Naltrexone 4.5mg PO OD for 120 days. Participant will complete a a 4 week titration to target dose of 4.5mg. Week 1-2: 1.5mg PO OD. Week 3-4: 3.0mg PO OD. Week 5-16: 4.5mg PO OD. Participant will be provided with masked capsules in blister packs.

Also known as: LDN

Low Dose Naltrexone

Microcrystalline cellulose DRUG

Participant takes microcrystalline cellulose 4.5mg PO OD for 120 days. Participant will complete a a 4 week titration to target dose of 4.5mg. Week 1-2: 1.5mg PO OD. Week 3-4: 3.0mg PO OD. Week 5-16: 4.5mg PO OD. Participant will be provided with masked capsules in blister packs.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (1)

• Dani M, Fedorowski A. Tackling POTS Needs More Than Just a Sympathetic Approach. Hypertension. 2024 Nov;81(11):2248-2250. doi: 10.1161/HYPERTENSIONAHA.124.23716. Epub 2024 Oct 16. No abstract available.

  PMID: 39413203 DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Naltrexone; microcrystalline cellulose

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Satish R Raj, MD MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish R Raj, MD MSCI

CONTACT

4032106152; autonomic.research@ucalgary.ca

Rasha Hamzeh, RN

CONTACT

autonomic.research@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drug and placebo will be masked by the pharmacy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 6, 2022
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share