Psilocybin-Assisted Therapy
ConditionPTSD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.
Eligibility criteria
Qualifiers
Meet criteria for PTSD due to trauma occurring at least 6 months prior based on CAPS-5-R diagnostic scoring rules.
Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated
Are 18 years and older.
Are able to visually read and understand the English language and give written informed consent.
Disqualifiers
Are not able to give adequate informed consent.
Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders. "Compensation litigation" will not include veterans who are service connected through PTSD or other conditions.
Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma, lack social support, or lack a stable living situation.
Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
Trial design
Treatments tested in this trial
- psilocybin
- Supportive Therapy
- Prolonged Exposure Therapy
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
Georgia Department of Veterans Services
Collaborator
Source ClinicalTrials.gov