Psilocybin for the Treatment of Migraine Headache
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches, Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 2/6/2019 |
| Start Date: | November 1, 2017 |
| End Date: | March 1, 2020 |
| Contact: | Emmanuelle Schindler, MD, PhD |
| Email: | emmanuelle.schindler@va.gov |
| Phone: | 203-932-5711 |
Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study I
The purpose of this study is to investigate the effects of oral psilocybin in migraine
headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately
14 days apart. Subjects will be randomized to the order of treatment and they will be
randomized to receive either low or high dose psilocybin. Subjects will maintain a headache
diary prior to, during, and after the treatments in order to document headache frequency and
intensity, as well as associated symptoms, in both the short and long-term.
headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately
14 days apart. Subjects will be randomized to the order of treatment and they will be
randomized to receive either low or high dose psilocybin. Subjects will maintain a headache
diary prior to, during, and after the treatments in order to document headache frequency and
intensity, as well as associated symptoms, in both the short and long-term.
Inclusion Criteria:
- Diagnosis of migraine headache per ICHD-3beta criteria
- Typical pattern of migraine attacks with approximately two migraines or more weekly
- Attacks are managed by means involving no more than twice weekly triptan use
- Age 21 to 65
Exclusion Criteria:
- Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- Axis I psychotic disorder in first degree relative
- Unstable medical condition, severe renal, cardiac or hepatic disease, pacemaker, or
serious central nervous system pathology
- Pregnant, breastfeeding, lack of adequate birth control
- History of intolerance to psilocybin, LSD, or related compounds
- Drug or alcohol abuse within the past 3 months (excluding tobacco)
- Urine toxicology positive to drugs of abuse
- Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine)
within 5 half-lives of test days
- Use of serotonergic antiemetics (i.e. ondansetron) in the past 2 weeks
- Use of antidepressant medication (i.e. TCA, MAOI, SSRI) in the past 6 weeks
- Use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the
past 2 weeks
We found this trial at
1
site
West Haven, Connecticut 06516
Principal Investigator: Deepak C D'Souza, M.D.
Phone: 203-932-5711
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