The role of the stress experience in supporting positive effects following psilocybin: a randomized, controlled clinical trial using the cortisol synthesis inhibitor metyrapone in healthy adults
Summary
In this study, we are looking at factors that contribute to positive experiences when given psilocybin (“magic mushrooms”). Specifically, we are interested in the role cortisol plays in positive outcomes induced by psilocybin.
If you take part in this study, you will be given psilocybin and a medication called metyrapone on four different occasions. You will receive both high- and low-doses of psilocybin. You will fill out questionnaires and provide blood samples at various time points throughout the study.
Participating in this study will take about 17 weeks. There will be a total of at least 10 in-person visits throughout the course of the study, and an additional eight virtual visits.
Eligibility
Eligible ages: 22 to 65
Accepts healthy participants: Yes
Inclusion criteria:
1. 22 to 65 years of age at the time of screening.
2. Ability to read/write in English.
3. At least one positive experience with psychedelics or cannabis, or other altered states
4. Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation
5. Agree not to take sildenafil (Viagra), tadalafil, or similar medications within 72 hours of drug administration
Exclusion criteria:
1. Current diagnosis of a psychiatric/mental disorders.
2. Endocrine disorders or dysfunction.
3. Personal or family history of schizophrenia or bipolar disorder.
4. Currently taking tricyclic antidepressants, lithium, SSRIs, MAOIs, haloperidol, or benzodiazepines. Participants may be included following a wash-out period of at least 4-weeks prior to baseline for fluoxetine and 2-weeks prior to baseline for all other medications
5. Currently pregnant, nursing, or trying to become pregnant
6. Current or recent participation in a clinical trial involving medication administration
7. Recently suffered a traumatic brain injury (TBI), or a moderate/severe TBI at least once in lifetime
Participate
Additional information
Contact information
PhD Student Ana Deutsch, ana.deutsch@ucalgary.ca
Principal investigator:
Valerie Taylor
Clinical trial:
Yes
REB-ID:
REB24-1121