- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05363514
Low Dose Naltrexone Use in Patients With POTS
A Pilot Study of Low Dose Naltrexone Use in Patients With Postural Orthostatic Tachycardia Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Satish R Raj, MD MSCI
- Phone Number: 4032106152
- Email: autonomic.research@ucalgary.ca
Study Contact Backup
- Name: Rasha Hamzeh, RN
- Email: autonomic.research@ucalgary.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Dose Naltrexone
Low Dose Naltrexone 4.5mg OD PO.
Capsules are masked and provided in blister packs.
|
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 Names:
|
Placebo Comparator: Placebo
Microcrystalline cellulose 4.5mg OD PO.
Capsules are masked and provided in blister packs.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
4 months
|
Cytokines
Time Frame: 4 months
|
Change in plasma cytokine levels from pre-treatment baseline to treatment (4 months)
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Satish R Raj, MD MSCI, University of Calgary
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Disease
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Syndrome
- Tachycardia
- Postural Orthostatic Tachycardia Syndrome
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Naltrexone
Other Study ID Numbers
- REB22-0565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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