Psilocybin-assisted Therapy for Phantom Limb Pain

This double-blind placebo-controlled pilot study (n=20) conducted by the University of California, San Diego aims to investigate the safety and efficacy of psilocybin (25mg) in treating chronic phantom limb pain (PLP).

Participants, aged 18 to 75, with amputation of one extremity and experiencing PLP of at least one month’s duration and intensity of at least 3 out of 10 on the VAS, will be included. They must be fluent in English and willing to refrain from certain medications and psychoactive drugs during the study period.

The study will employ psychophysical and fMRI testing to assess pain symptoms and other mood, attitude, and behavioural changes. Primary hypotheses include the safety of psilocybin administration and its potential to reduce pain scores.

Participants will be randomly allocated to receive either 25mg oral psilocybin or 100mg oral niacin. Outcome measures will include changes in phantom limb pain intensity, visual analogue scale pain ratings, cerebral blood flow, and the Brief Pain Inventory.

The study began in January 2022 and is expected to be completed by June 2024.

Topic Pain
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 01 January 2022
End date 01 June 2024
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 75
Therapy Yes

Trial Details

This double-blind placebo-controlled pilot study seeks to investigate whether psilocybin can be safely administered to people with chronic phantom limb pain (PLP) in a supportive setting with close follow-up, and its effects on pain symptoms and other moods, attitudes, and behaviors. The investigators' primary hypotheses are that psilocybin is safe to administer in people with PLP and that it will reduce scores on measures of pain. The investigators will also assess a number of secondary measures related to the behavioral and neural responses to pain after psilocybin treatment.

NCT Number NCT05224336

Sponsors & Collaborators

University of California San Diego
The Psychedelics and Health Research Initiative (PHRI) at UC San Diego conducts novel basic and clinical research on the use of psychedelics.

Data attribution

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