Psilocybin Research
Psilocybin-assisted Cognitive Behavioral Therapy for Depression
SUMMARY
The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder.
This study has two phases:
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PHASE 1:
Phase I will involve an open trial of PA-CBT where participants will receive two doses of psilocybin (10mg and then 25mg, separated by one month) plus 12 sessions of cognitive behavioral therapy.
DETAILS
Status: PHASE I - Concluded, no longer accepting patients
Start Date: June 2023
Completion Date: December 2025 (estimated)
Sponsor: University of California, Los Angeles
ID: NCT05227612
Other ID's:
- 21-002134
Phase: Phase 1 research study
Study Type: Interventional
Participants: Expecting 30 study participants
Last Updated: March 2025
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PHASE II:
Phase II will be a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).
DETAILS
Status: PHASE II - Active, accepting new patients
Start Date: June 2023
Completion Date: December 2027 (estimated)
Sponsor: University of California, Los Angeles
ID: NCT05227612
Other ID's:
- 21-002134
Phase: Phase 1 research study
Study Type: Interventional
Participants: Expecting 50 study participants
Last Updated: March 2025
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ELIGIBILITY
If you’re between the ages of 21-60 and experience depression, you may be eligible. Please complete the pre-screener survey to add yourself to our waitlist:
https://uclahs.az1.qualtrics.com/jfe/form/SV_6x3GHvVGkTKABRI
LOCATION
UCLA Semel Institute
Los Angeles California 90095 United States
LEAD SCIENTIST AT UCLA
Assistant Clinical Professor, Psychiatry and Biobehavioral Sciences, Medicine.
KEYWORDS
Major Depressive Disorder, psilocybin, cognitive behavioral therapy (CBT), Depressive Disorder, Psilocybin + CBT
