Health TrialsbyHealthPanel

Low Dose Naltrexone Use in Patients With POTS

ConditionPostural Orthostatic Tachycardia Syndrome
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Low Dose NaltrexoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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).

Time frame
4 months

Secondary outcomes

1

RAND 36 Health Related Quality of Life Score

Change in RAND 36 Health Related Quality of Life Score from pre-treatment baseline to treatment (4 months).

Time frame
4 months
2

Cytokines

Change in plasma cytokine levels from pre-treatment baseline to treatment (4 months)

Time frame
4 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: