Psilocybin treatment for PTSD

Psilocybin for PTSD With or Without Psychotherapy: A Pilot Study of Safety and Efficacy

This study is testing whether psilocybin therapy can help adults with chronic PTSD feel better when combined with therapy and standard support compared to just standard support alone.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 21 Years to 75 Years
• Sex: All
• Sponsor: Johns Hopkins University (other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06407635 on ClinicalTrials.gov

What this trial studies

This open-label, controlled study at the Johns Hopkins Center for Psychedelic and Consciousness Research aims to evaluate the safety and efficacy of psilocybin therapy in adult patients with chronic PTSD who are currently on serotonin reuptake inhibitors. The study will compare two doses of psilocybin and investigate the effects of trauma-focused psychotherapy combined with standard psychological support versus standard psychological support alone. Participants will undergo preparatory meetings followed by two psilocybin sessions, with assessments of PTSD and mood symptoms conducted before and after the sessions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 to 75 with a confirmed diagnosis of PTSD who have been stable on a serotonin reuptake inhibitor for at least two weeks.

Not a fit: Patients who are not currently taking a serotonin reuptake inhibitor or those at high acute risk for suicidality may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce PTSD symptoms and improve overall wellbeing and quality of life for patients.

How similar studies have performed: Other studies have shown promising results with psilocybin for various mental health conditions, suggesting potential for success in this novel application for PTSD.

Eligibility criteria

Inclusion Criteria:

* 21 to 75 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 (e.g. selective serotonin reuptake inhibitor (SSRI), serotonin and norepinephrine reuptake inhibitor (SNRI), at a stable dose for at least two weeks.
* 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 any psychoactive drugs, including alcoholic beverages within 24 hours of each drug administration. The exception is caffeine and nicotine.
* Agree not to take any as needed (PRN) medications on the mornings of drug sessions
* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
* Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
* Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 2 years; total hallucinogen use less than 10 times)
* Have at least a high school level of education or equivalent (e.g. GED).
* Weigh between 40kg - 120kg.
* (for female participants) Agree to use highly effective birth control measure within two weeks of completing the dosing sessions.

(for male participants) Agree to use contraception and refrain from sperm donation within two weeks of completing dosing sessions, as the reproductive safety for psilocybin is not yet established.

Exclusion Criteria:

General medical exclusion criteria:

* Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
* Cardiovascular conditions: coronary artery disease, stroke, angina, hypertension with resting blood pressure systolic \>139 or diastolic \>89, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT interval (i.e., heart-rate corrected QT interval (QTc) \> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year
* Epilepsy with history of seizures
* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
* Currently taking a Monoamine Oxidase Inhibitor

Psychiatric Exclusion Criteria:

* Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I or II Disorder
* Current or history within one year of meeting DSM-5 criteria for a severe alcohol, tobacco, or other drug use disorder (excluding caffeine)
* Have a first degree relative with schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I.
* Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
* History of a medically significant suicide attempt
* Unwilling or unable to pause concurrent psychotherapy during the study.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Sandeep Nayak, MD — Johns Hopkins University
• Study coordinator: Jacob Babcock

Conditions: Post Traumatic Stress Disorder