Treatment of Persistent Post-concussive Symptoms With Psilocybin Assisted Therapy

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2024
The goal of this randomized controlled trial is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy as an intervention to reduce symptom burden in adult patients (aged 18-65) with persistent post-concussion symptoms (PPCS). This trail will test the following 2 aims: AIM 1 : To test the safety and feasibility of an active psilocybin-assisted psychotherapy to an active control for patients with PPCS AIM 2: To evaluate the efficacy of an active psilocybin-assisted psychotherapy compared to an active control as a treatment for PPCS Participants will be asked to: * Complete a 2 part screening process * Attend a baseline assessment * Complete a psychoeducation preparation session(s) * Attend psilocybin administration session (receive high dose \[25mg\] or low dose psilocybin \[1mg\]) * Complete 5-6 weekly sessions of BrainACT * Repeat outcome measures at 1-week, 4 weeks, 3 months, and 6 months post-psilocybin administration (online only at 6 months).
Epistemonikos ID: cbc39a9c65b82b39c2d6a1201b6e528c7a9bae80
First added on: Oct 01, 2024