Clinical TrialChronic PainPsilocybinPsilocybinPsilocybinPsilocybinPlaceboRecruiting

Psilocybin Therapy for Chronic Low Back Pain

Randomized, quadruple-blind, parallel-group trial (n=30) testing single oral psilocybin doses (1–30 mg) combined with zolpidem, modafinil, both, or placebo for adults with chronic low back pain.

Target Enrollment
30 participants
Study Type
Phase I/II interventional
Design
Randomized, quadruple Blind

Detailed Description

This study evaluates whether psilocybin therapy helps patients cope with chronic low back pain more effectively. Procedures occur at UCSF; participants receive two preparation sessions, a single dosing session (6–8 hours), three integration sessions, and follow-up visits.

Four parallel arms compare single-dose psilocybin (1–30 mg, oral) combined with zolpidem and modafinil, zolpidem alone, modafinil alone, or placebo. Outcomes include pain-related distress, functioning, mood and safety.

Study Protocol

Preparation

2 sessions

Dosing

1 sessions
420 min each

Integration

3 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin + Zolpidem + Modafinil

experimental

Single oral dose psilocybin (1–30 mg) with zolpidem and modafinil.

Interventions

  • Psilocybin1 - 30 mg
    via Oral• single dose• 1 doses total
  • Compound
    via Oral• single dose

    Zolpidem and modafinil oral co-administration.

Psilocybin + Zolpidem

experimental

Single oral dose psilocybin (1–30 mg) with zolpidem (and placebo for modafinil).

Interventions

  • Psilocybin1 - 30 mg
    via Oral• single dose• 1 doses total
  • Compound
    via Oral• single dose

    Zolpidem oral (placebo for modafinil).

Psilocybin + Modafinil

experimental

Single oral dose psilocybin (1–30 mg) with modafinil (and placebo for zolpidem).

Interventions

  • Psilocybin1 - 30 mg
    via Oral• single dose• 1 doses total
  • Compound
    via Oral• single dose

    Modafinil oral (placebo for zolpidem).

Psilocybin + Placebo

experimental

Single oral dose psilocybin (1–30 mg) with oral placebo.

Interventions

  • Psilocybin1 - 30 mg
    via Oral• single dose• 1 doses total
  • Placebo
    via Oral• single dose• 1 doses total

    Oral placebo.

Participants

Ages
25 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age 25 to 70 years old
  • Comfortable speaking and writing in English
  • Diagnosed with chronic low back pain
  • Able to attend all in-person visits at UCSF as well as virtual visits
  • Has tried at least two previous medications/ procedures and physical therapy trials for low back pain

Exclusion Criteria

  • Exclusion Criteria:
  • Chronic low back pain that is attributed to malignancy, subacute or acute fracture or infection
  • Low back pain with radiation below the knee
  • Low back pain with neurologic signs present
  • Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, antipsychotics, and stimulants
  • A health condition that makes study unsafe or unfeasible, determined by study physicians

Study Details

Locations

University of California San Francisco — San Francisco, California, United States

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