Using IV Ketamine to Treat Chronic Daily Headaches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of high-dose intravenous ketamine infusions for patients suffering from chronic daily headaches. It is a multicenter, placebo-controlled, randomized trial that includes blinding of participants and assessors to ensure unbiased results. Participants will receive either ketamine or a placebo while being monitored by anesthesiologists, and their headache frequency, intensity, mood, activity, sleep, and quality of life will be assessed over three months. The study aims to provide comprehensive data on the potential benefits of ketamine for chronic pain management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-75 years
2. CDH diagnosis preceding trial enrollment with headache episodes lasting for 4 or more hours occurring on 15 or more days in a month for 3 or more months (International Headache Society-IHS criteria)
3. Normal liver and kidney function tests

Exclusion criteria:

1. Pregnant or breastfeeding patients
2. Pre-existing renal impairment
3. Pre-existing liver impairment
4. Chronic benzodiazepine or antipsychotic medication use
5. History of cerebrovascular event
6. Significant and untreated hypertension or severe cardiac condition
7. Hypothyroidism
8. Glaucoma
9. Concomitant use of strong CYP2B6 or CYP2C8 inhibitor
10. Allergy or intolerance to ketamine
11. Pheochromocytoma
12. Any significant cognitive or language barriers that impede participation
13. CGRP antagonist use in 1 month or Onabotulinum-toxin A 3 months before infusion
14. Active diagnosis of Post-Traumatic Stress Disorder (PTSD)
15. Active diagnosis of Substance Use Disorder
16. Patients taking opioid medications with daily Oral Morphine Equivalents ≥80 mg

Where it's running

• Women's College Hospital
  Toronto, Ontario, Canada Recruiting
• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Anuj Bhatia, MD, PhD — University Health Network, Toronto
• Study coordinator: Emad Al Azazi
• Email: KetHead@uhn.ca
• Phone: +1 (416) 603 5800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.