Study of Low-dose Naltrexone in Chronic Migraine With Fibromyalgia

Thomas Jefferson University

Status: Enrolling

Conditions: Fibromyalgia; New Daily Persistent Headache; Chronic Migraine

Treatments: Other: Migraine diary and Questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT05536050

22D.486

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.