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Low Dose Naltrexone Use in Patients With POTS

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ClinicalTrials.gov Identifier: NCT05363514
Recruitment Status : Not yet recruiting
First Posted : May 6, 2022
Last Update Posted : November 28, 2023
Sponsor:
Information provided by (Responsible Party):
University of Calgary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Postural Orthostatic Tachycardia Syndrome Drug: Low Dose Naltrexone Drug: Microcrystalline cellulose Phase 4

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 using a 0-100 Fatigue Visual Analogue Scale. The secondary hypotheses are that LDN will improve quality of life in patients with POTS when compared to placebo using the RAND36 Health Related Quality of Life Survey, and that LDN will reduce inflammatory cytokine concentrations in patients with POTS compared to placebo. Tertiary outcomes will compare autonomic symptoms and orthostatic vital signs between LDN and placebo and also evaluate feasibility of a larger scale clinical trial.

Study Design and Methodology: We will recruit 80 patients with POTS across three sites.Participants will be randomized to the LDN group or the placebo group, for a 16 week study. Before beginning the study drug, POTS patients will complete a baseline assessment including fatigue evaluation, cytokine levels, orthostatic vital signs, orthostatic symptoms, and quality of life. After the baseline assessment, POTS patients will begin the study drug titration (LDN or placebo) as follows: 1.5mg for 2 weeks, 3.0mg for 2 weeks, 4.5 mg for 12 weeks. If participants do not tolerate the target dose (4.5mg), then will reduce to the highest tolerable dose. Participants will complete virtual assessments at 1, 2 and 3 months (surveys). Participants will also be provided with a diary to record symptoms. After 4 months, participants will again attend the research clinic/lab for a final assessment (same procedure as the baseline assessment).

Anticipated Outcomes: These data will allow us to evaluate the efficacy of LDN as a treatment in POTS. The results of this study could be used to inform the feasibility and design of larger clinical trials evaluating LDN use in POTS with funding from a national granting agency.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study drug and placebo will be masked by the pharmacy.
Primary Purpose: Treatment
Official Title: A Pilot Study of Low Dose Naltrexone Use in Patients With Postural Orthostatic Tachycardia Syndrome
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Dose Naltrexone
Low Dose Naltrexone 4.5mg OD PO. Capsules are masked and provided in blister packs.
 Drug: Low Dose Naltrexone
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.
Other Name: LDN
Placebo Comparator: Placebo
Microcrystalline cellulose 4.5mg OD PO. Capsules are masked and provided in blister packs.
 Drug: Microcrystalline cellulose
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.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Fatigue Visual Analogue Scale (VAS) [ Time Frame: 4 months ]
    Change in Fatigue VAS from pre-treatment (baseline) to treatment (4 months). The score is measured from 0-100 (0 is no fatigue).


Secondary Outcome Measures :
  1. RAND 36 Health Related Quality of Life Score [ Time Frame: 4 months ]
    Change in RAND 36 Health Related Quality of Life Score from pre-treatment baseline to treatment (4 months).

  2. Cytokines [ Time Frame: 4 months ]
    Change in plasma cytokine levels from pre-treatment baseline to treatment (4 months)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05363514


Contacts
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Contact: Satish R Raj, MD MSCI 4032106152 autonomic.research@ucalgary.ca
Contact: Rasha Hamzeh, RN autonomic.research@ucalgary.ca

Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Satish R Raj, MD MSCI University of Calgary
More Information
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Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT05363514    
Other Study ID Numbers: REB22-0565
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Calgary:
POTS
LDN
Low Dose Naltrexone
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
 Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents