Start
Completion

Psilocybin-assisted Therapy for Alcohol Use Disorder

Not yet recruitingRegisteredCTG

This double-blind, randomised, Phase II trial (n=90) will evaluate the efficacy of psilocybin-assisted therapy (25 mg x2) versus niacin (250 mg x2) plus therapy to reduce heavy drinking days in people with Alcohol Use Disorder.

Details

Randomised, double-blind, parallel-group Phase II trial comparing two 25 mg psilocybin dosing sessions plus psychotherapy versus niacin 250 mg plus psychotherapy in adults with moderate to severe AUD; primary outcome is change in heavy drinking days.

Participants receive 12 weekly therapy sessions, two dosing sessions with integration after each dosing (total of four integration sessions), and follow-up visits; secondary outcomes include depression and anxiety symptom change and tolerability.

Topics:Alcohol Use Disorder (AUD)

Registry

Registry linkNCT06444243