Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Study Overview
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Brief Summary
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This research aims to look at the effect of low-dose naltrexone on the severity and frequency of attacks in people with chronic migraine with or without new daily persistent headache and fibromyalgia. A few studies suggest low-dose naltrexone is effective for fibromyalgia, but it has not been studied in patients with migraine and headaches. Our goal is to see if there is an improvement in either severity and frequency of attacks and overall impact on quality of life over a three-month period.

Official Title
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Prospective Observational Pilot Study of Low-dose Naltrexone in Patients With Chronic Migraine With Comorbid Fibromyalgia

Conditions
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Chronic Migraine, Fibromyalgia, New Daily Persistent Headache

Intervention / Treatment
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* Other: Migraine diary and Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be adults of all genders ages 18 and older. Patients with a diagnosis of CM (with or without NDPH) by IHC-3 criteria, diagnosed by a certified headache specialist. Subjects who received a new prescription for LDN Fibromyalgia-diagnosed according to Fibromyalgia Rapid Screening Tool Subjects should be on stable headache and migraine preventives for the past 2 months with no plans to change medication for the next 4 months. Subjects willing to maintain a headache/migraine diary one month prior to taking medication and while taking the medication, either physical or electronic diary of their choice. Subjects willing to fill out pre and post intervention surveys Subjects willing to comply with planned follow up phone calls and visits. Exclusion Criteria: Not planning on follow up care with clinician. Patients with decreased decision-making capacity in which the investigator's opinion would interfere with the person's ability to provide informed consent and complete study questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Migraine diary and Questionnaires|Patients who already have a prescription for low-dose naltrexone will be administered questionnaires twice during the trial. Additionally, patients will maintain migraine diary for the duration of the trial.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness on migraine | Monthly migraine days | 9-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness on headache | Monthly headache days | 9-12 weeks | 
| Intensity | Average peak intensity of migraine | 9-12 weeks | 
| The Migraine Disability Assessment Test | Impact of migraine on daily life | 9-12 weeks | 
| Migraine Specific Quality of Life Index | Impact of migraine and migraine treatment on quality of life | 9-12 weeks | 
| Patient Health Questionnaire | Monitor depression and changes in signs/symptoms of depression | 9-12 weeks | 
| Fibromyalgia Impact Questionnaire | Assess health status of patients with fibromyalgia | 9-12 weeks | 
| Patients' Global Impression of Change | Assess patient's belief in efficacy of treatment | 9-12 weeks |