Randomised, parallel-group study (n=82 actual) comparing a single high-dose psilocybin session (30 mg/70 kg) plus CBT versus standard transdermal nicotine patch plus CBT for nicotine-dependent smokers.
Randomised, parallel-group comparative efficacy trial enrolling nicotine-dependent adults who receive a 13-week cognitive behavioural smoking-cessation programme with either a single high-dose psilocybin session (30 mg/70 kg) on the Target Quit Date or an 8–10 week transdermal nicotine-patch regimen.
Outcomes include repeated biologically verified smoking-status assessments through 8 weeks post-quit and follow-ups at ~3, 6 and 12 months; a subset (n=50) undergo MRI pre- and post-target quit date to probe neural mechanisms.
13-week CBT with a single high-dose psilocybin session (Target Quit Date, week 5).
30 mg per 70 kg; single day-long session
13-week CBT with standard transdermal nicotine patch regimen beginning on Target Quit Date (week 5).
Transdermal nicotine patch per label: for >10 cig/day: 21 mg daily weeks 1–6, 14 mg weeks 7–8, 7 mg weeks 9–10; for ≤10 cig/day: 14 mg weeks 1–6, 7 mg weeks 7–8
This follow-up study (n=15) to an open-label pilot-study of psilocybin-facilitated smoking addiction treatment found that the mystical experience (MEQ) but not the intensity of the experience was predictive of smoking abstinence (80% at 6-month follow-up).