Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYale University
About this trial
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.
Eligibility criteria
Qualifiers
1. Ability to provide informed consent in English.
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Male and female participants aged 18-65 years.
Disqualifiers
1. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder.
2. Personal or family history of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with psychotic features; any history of substance-induced psychosis or current psychotic symptoms at Screening per the Brief Psychiatric Rating Scale.
3. Active suicidal ideation or behavior in the past 3 months, as indicated on the C-SSRS.
4. Lifetime use of classic psychedelics (5-HT2A agonists) within the preceding 12 months, or unwillingness to abstain from their use for up to 4 weeks post-dose.
Trial design
Treatments tested in this trial
- Psilocybin 10 mg
- Psilocybin 25 mg
- Niacin 100 mg
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov