Psilocybin-Assisted Therapy

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07332143
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Psilocybin combined with supportive therapy
    All participants will receive a single 25 mg dose of psilocybin during the experimental session, which occurs during to their respective therapy model. Then, participants will receive 2 support (integrative) therapy sessions that will be 1 week apart. In between these sessions, subjects will complete a series of online surveys to track treatment progress.
  • Experimental: Group 2: Psilocybin combined with massed prolonged exposure (PE) therapy
    All participants will receive a single 25 mg dose of psilocybin during the experimental session, followed by 10 prolonged exposure (PE) therapy sessions for 10 days. In between these sessions, participants will complete a series of online surveys to track treatment progress.

Primary Outcome Measure

Change in PTSD symptoms based on CAPS-5-R total severity score [ Time Frame: Baseline, 1-month post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Anna Wise, PhD
[email protected]
404-712-1035
Jessica Maples-Keller, PhD
[email protected]
404-778-2075
Anna Wise, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Emory University Hospital· Atlanta, GA

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