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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Are able to swallow pills.
✓. Agree to have study visits video and/or audio recorded, including dosing session, Independent Rater assessments, and non-drug psychotherapy sessions.
✓. Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
✓. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
Exclusion criteria
✕. 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.
What they're measuring
1
Change in PTSD symptoms based on CAPS-5-R total severity score
Timeframe: Baseline, 1-month post-intervention
2
Change in PCL-5 score
Timeframe: Baseline, 1, 6 and 12 months post-intervention
3
Depression symptoms (PHQ-9)
Timeframe: Baseline, 1, 6 and 12 months post-intervention
✕. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.
✕. Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.
✕. Have a history of or current bipolar type 1 disorder, or primary psychotic disorder (e.g., schizophrenia), as assessed via DIAMOND and clinical interview, dementia; or intellectual disability.
✕. Have current major depressive disorder with psychotic features assessed via DIAMOND.
✕. Have met criteria at any time during their life for hallucinogen substance use disorder.