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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
psilocybin
Drug25 mg
Supportive Therapy
BehavioralTreatment includes non-directive psychological support across the preparatory, dosing, and integration sessions. Preparatory sessions include psychoeducation regarding psilocybin's subjective effects and establish strategies for psilocybin related support, including boundaries around physical touch. Therapists encourage setting intention for dosing day, and practicing experiential exercises. Integration sessions include processing the participant's experience of their psilocybin administration session. Therapists will support participants in identifying activities for ongoing integration outside of sessions. The standard care for supportive therapy will be modeled in this study.
Prolonged Exposure Therapy
BehavioralProlonged Exposure (PE) Therapy will be conducted for 10 sessions. They will consist of repeated exposures to trauma memories (imaginal exposure) consistent with the manualized protocol for massed exposure therapy. Also consistent with this treatment manual, participants will listen to imaginal exposures and conduct in real life exposures outside of PE sessions for "homework". The standard care for PE therapy will be modeled in this study.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Group 1: Psilocybin combined with supportive therapyExperimental treatment 2 interventions
Group B: Group 2: Psilocybin combined with massed prolonged exposure (PE) therapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in PTSD symptoms based on CAPS-5-R total severity score
PTSD symptoms will be evaluated using the Revised Clinician-Administered PTSD Scale for DSM-5, that refers to 20 core symptoms as CAPS-5, each rated on a 0-4 severity scale (0 = absent to 4 = extremely severe), combining frequency and intensity. Total possible score range is 0 to 80 with higher scores correlating with worse outcome.
Time frame
Baseline, 1-month post-intervention2
Change in PCL-5 score
The PCL-5 is a 20-item self-report measure of DSM-5 PTSD symptoms. Scores on the PCL range from 0 to 80, with higher scores indicating higher symptom severity, and a cutoff of 33 indicating clinical levels of PTSD symptoms.
Time frame
Baseline, 1, 6 and 12 months post-intervention3
Depression symptoms (PHQ-9)
The PHQ-9 is a 9-item self-report measure of depressive symptoms. A score of 10 or above indicative of a possible major depressive episode, and it provides a measure of severity of these symptoms. Total possible score range is 0-29, higher score correlates with worse outcome.
Time frame
Baseline, 1, 6 and 12 months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Georgia Department of Veterans Services
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: