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Psilocybin-Assisted Therapy

ConditionPTSD
Trial statusRecruiting
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 volunteers

Qualifiers

Meet criteria for PTSD due to trauma occurring at least 3 months prior based on CAPS-5-R diagnostic scoring rules.

Able to speak and read English (due to standardization of outcome measures).

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.

Disqualifiers

Are not able to give adequate informed consent.

Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.

Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.

Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).

Trial design

Design model

Parallel

Treatments tested in this trial

  • psilocybin

    Drug

    25 mg

  • Supportive Therapy

    Behavioral

    Treatment 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

    Behavioral

    Prolonged 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 groups
Group 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-intervention
2

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-intervention
3

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-intervention

Secondary outcomes

Other outcomes

Sponsors 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
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