Psilocybin for PTSD With or Without Psychotherapy: A Pilot Study of Safety and Efficacy
The proposed open-label, controlled study at the Johns Hopkins Center for Psychedelic and Consciousness Research (CPCR) will test the following primary hypotheses in adult patients with chronic PTSD who are currently taking a serotonin reuptake inhibitor: psilocybin therapy will be feasible and safe for participants, significantly remediate PTSD symptoms, and enhance wellbeing and quality of life. In addition, the study will examine whether elements of evidence-based trauma-focused psychotherapy enhance treatment response when paired with psilocybin.
• Be at least 21 years old
• Have given written informed consent
• Have a confirmed DSM-5 diagnosis of Post-Traumatic Stress Disorder with symptom duration \>= 6 months
• Have a baseline CAPS-5 score of \>=35
• Currently taking a serotonin reuptake inhibitor (SSRI or SNRI) at a stable dose for at least 3 months.
• Be judged by study team clinicians to be at low acute risk for suicidality
• Be medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
• Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.
• Agree to refrain from using alcohol, anxiolytics, stimulants, sedatives or hypnotics, opioids, dissociatives, cannabinoids, or other unapproved substances within 24 hours of psilocybin administration. Caffeine and nicotine are exceptions.
• Agree not to take any as needed (PRN) medications on the mornings of drug sessions
• Agree to stop taking 5HT2A antagonist medications at least 5 half-lives before psilocybin dosing.
• Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
• Have no classic psychedelic use in the past five years.
• Have at least a high school level of education or equivalent (e.g. GED).
• Weigh at least 40kg.
• (for female participants) Agree to use highly effective birth control measure within two weeks before and after dosing sessions.
• (for male participants) Agree to use contraception and refrain from sperm donation two weeks before and after dosing sessions, as the reproductive safety for psilocybin is not yet established.