Actively Recruiting
Cocoa Extract for Migraine Trial
Led by Brigham and Women's Hospital · Updated on 2025-07-14
114
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. The main questions it aims to answer are: * Will we be able to enroll 114 participants during the recruitment period? * Will participants take study pills daily during the pill-taking period? Researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population. Participants will be asked to: * Provide two urine samples * Complete daily questionnaires * Take four study pills a day for 12 weeks
CONDITIONS
Official Title
Cocoa Extract for Migraine Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men aged 2 years or older
- Self-reported clinician diagnosis of migraine with or without aura not meeting criteria for chronic migraine
- Confirmed migraine or probable migraine by the American Migraine Study migraine screener
- History of migraine for at least one year
- Self-report of 4 to 14 migraine attacks in the 30 days before enrollment
- Completion of at least 22 headache diary days during the 28-day run-in period with migraine frequency between 4 and 14 days
- No new migraine medication use within the past 3 months if currently treated
- No new behavioral interventions within the past 3 months and agreement not to start new ones during the trial
- Willingness to complete all study procedures and be randomized to any group
- Fluent in English
- Own an iPhone or Android device and willing to download the MyCap app
You will not qualify if you...
- History of stroke, transient ischemic attack, brain or spine surgery, concussion treatment, cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder
- Kidney failure, dialysis, or any condition that may cause difficulty following the protocol
- Current alcohol or substance abuse
- Clinician diagnosis of medication overuse headache
- Botox treatment for migraine within the past 6 months
- Failure to return the baseline urine sample
- Currently pregnant, nursing, or planning pregnancy during the study
- Unwilling to avoid out-of-study cocoa extract supplements during the trial
- Extreme sensitivity to caffeine
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
P
Pamela M Rist, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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