Safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder [Psi-GAD-1]: a randomised triple-blind active-placebo-controlled trial

This trial (n=72) will investigate the effects of psilocybin (2x, 25/30mg) versus an active placebo (diphenhydramine) in patients with generalised anxiety disorder (GAD). The trial will be one of the largest to date in Australia.

Topic Anxiety
Compound Psilocybin Placebo
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

Monash University
The Clinical Psychedelic Lab, established in 2020, within the Dept Psychiatry at Monash University is the first of its kind in Australia, leading the development and implementation of psychedelic therapies. The lab has played a central role in establishing the field of clinical psychedelic research in Australia.

Incannex Healthcare
Incannex Healthcare is a clinical-stage cannabinoid and psychedelic medicine developer.

Papers

Participant experiences of therapeutic touch in psilocybin-assisted therapy
This pre-print qualitative study (n=18) explores therapeutic touch in psychedelic-assisted therapy (PAT) for Generalised Anxiety Disorder (GAD). It finds that most participants valued touch during psilocybin dosing sessions, feeling it provided connection and helped manage intense emotional experiences, with some attributing therapeutic effects to it. The study emphasises the importance of a strong therapeutic relationship and recommends individualised use of touch, alongside further research on safety and therapist training.

Data attribution

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