Psilocybin-assisted therapy for the treatment of adjustment disorder due to incurable cancer
Research type
Research Study
Full title
A 12-week double-blind, randomised, parallel, placebo-controlled, phase IIa, clinical trial to assess the efficacy and safety of psilocybin-assisted psychotherapy versus psychotherapy alone for the treatment of adjustment disorder due to incurable cancer followed by a 9-month observation period and optional open label extension.
IRAS ID
1005369
Contact name
Justin Grant
Contact email
Sponsor organisation
Psyence Group
Eudract number
2022-000564-22
Research summary
Adjustment disorder is a stress-related condition which can affect a person’s quality of life and their ability to function. Scientists have recently shown that a psychedelic drug called psilocybin, when taken with talking therapy, may help people to feel better from a number of mental health conditions. We want to understand whether psilocybin-assisted therapy could reduce symptoms of adjustment disorder in patients who have received a diagnosis of incurable cancer. We will conduct a randomised controlled trial to compare the safety and efficacy of psilocybin-assisted therapy to placebo-assisted therapy in 60 patients. Patients will be randomised on a 1:1 basis, meaning half will receive psilocybin and half will receive placebo.
All participants will receive 3 preparatory therapy sessions, 1 dosing day session and 3 integrative therapy sessions over the course of 28 days. We will follow participants up at 4, 8 and 12-weeks and 6 and 9 months following randomisation. Those who still meet the criteria for adjustment disorder at 12-weeks will be offered the opportunity to participate in an open-label extension study where everyone receives psilocybin-assisted therapy. Those taking part in the extension will be followed up for a further 9 months, meaning they will participate in the trial for 12 months in total.
The primary outcome of the study will be to understand how effective psilocybin-assisted therapy is in reducing the severity of adjustment disorder in people with incurable cancer. This study has been registered with the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT).
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
22/EE/0115
Date of REC Opinion
15 Sep 2022
REC opinion
Further Information Favourable Opinion