Effects of Psilocybin in Post-Traumatic Headache
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 1/18/2019 |
| Start Date: | January 15, 2019 |
| End Date: | January 15, 2022 |
| Contact: | Emmanuelle Schindler, MD, PhD |
| Email: | emmanuelle.schindler@yale.edu |
| Phone: | 203-932-5711 |
Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II
The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic
headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose
psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at
various timepoints to measure levels of inflammatory peptides.
headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose
psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at
various timepoints to measure levels of inflammatory peptides.
Inclusion Criteria:
- Diagnosis of post-traumatic headache
- Typical pattern of headache attacks with approximately two attacks or more weekly
- Attacks are managed by means involving no more than twice weekly triptan use
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
950 Campbell Ave
West Haven, Connecticut 06516
West Haven, Connecticut 06516
(203) 932-5711
Principal Investigator: Deepak Cyril D'Souza, MD
Phone: 203-932-5711
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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