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.
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.
Single oral dose psilocybin (1–30 mg) with zolpidem and modafinil.
Zolpidem and modafinil oral co-administration.
Single oral dose psilocybin (1–30 mg) with zolpidem (and placebo for modafinil).
Zolpidem oral (placebo for modafinil).
Single oral dose psilocybin (1–30 mg) with modafinil (and placebo for zolpidem).
Modafinil oral (placebo for zolpidem).
Single oral dose psilocybin (1–30 mg) with oral placebo.
Oral placebo.