Search / Trial NCT06615908

Treatment of Persistent Post-concussive Symptoms With Psilocybin Assisted Therapy

Launched by UNIVERSITY OF CALGARY · Sep 23, 2024

Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

Psychotherapy Psilocybin Concussion Mild Traumatic Brain Injury Acceptance And Commitment Therapy

Description

The overall objective of this study is to evaluate the safety, feasibility, and efficacy of psilocybin assisted therapy administered with Acceptance and Commitment Therapy (ACT) modified to the needs of people with acquired injury (BrainACT) as an intervention to reduce symptom burden in patients 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/high dose (25mg) psilocybin-assisted psychotherapy to an active control (1mg) for adults with PPCS. Safety will be determined through the reporting o...

Gender

ALL

Eligibility criteria

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • * Individuals of all sexes, gender identities, and ethnicities
  • * Ages 18 to 65 years at the time of screening
  • * Diagnosis of concussion based on the 2024 ACRM criteria
  • * Meet ICD-10 criteria for PPCS for at least 3-months to a maximum of 5 years
  • * Have an overall RPQ score ≥ 13 with 3 or more symptoms scored ≥3
  • * Limited lifetime use of serotonergic hallucinogens
  • * Ability to read/write English
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • * Severe or moderate substance use disorder other than nicotine in past 6 months
  • * Lifetime diagnosis of schizophrenia or bipolar disorders (or first or second-degree relative)
  • * Active suicidal ideation or serious attempt within the past 1 year.
  • * Current pregnancy or nursing, trying to become pregnant
  • * Any notable abnormality on ECG or routine medical blood laboratory test
  • * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • * Epilepsy with a history of seizures
  • * Current or recent (within 12 weeks) participation in a clinical trial
  • * Cognitive impairment (SLUMS score \<20)
  • * Suffered a moderate/severe TBI at least once in lifetime
  • * Any other circumstances that, in the opinion of the investigators, compromises participant safety
  • * Not actively in litigation related to their mTBI or other injury

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Calgary, Alberta, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0