NCT06235411: PAD

Psilocybin in Alcohol Use Disorder With Comorbid Depression

Completed NA Last updated 19 March 2025

What this trial tests

NA trial testing Psilocybin therapy in Alcohol-Related Disorders in 30 participants. Completed in 9 January 2025.

Timeline

5 February 2024

Primary endpoint
19 November 2024

9 January 2025

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	5 February 2024
Primary completion	19 November 2024
Estimated completion	9 January 2025
Sites	1 location across France

Drugs / interventions tested

• Psilocybin therapy — full drug profile →
• Inactive Psilocybin therapy — full drug profile →
• Electroencephalogram
• Blood samples for the analysis of immune and inflammatory profiles
• stool samples — full drug profile →
• MRI functional and cerebral

Conditions studied

• Alcohol-Related Disorders — all drugs for Alcohol-Related Disorders →
• Depressive Disorder — all drugs for Depressive Disorder →
• Addiction — all drugs for Addiction →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

18 and older, any sex, with Alcohol-Related Disorders or Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Up to 40% of people with alcohol use disorder (AUD) experience depression. Depression is a risk factor for early relapse of AUD after withdrawal in a controlled environment. Promising data suggest the effectiveness of psilocybin, a psychedelic-type treatment, in depression and AUD. Following the acute effects of the psychedelic experience, which lasts approximately 6 hours, psilocybin action appears to be beneficial for preventing alcohol relapse in recently weaned people suffering from comorbid depression. Whilst the public perception of psilocybin therapy is poorly documented in France, the rapid changes in the legal status of psilocybin elsewhere, the positive media coverage of recent trials in depression, and the recent designation as an "innovative therapy" by the FDA could lead to the refusal of randomization of eligible participants. It is therefore essential to evaluate the feasibility and acceptability of psilocybin treatment and blinded randomized design in our clinical population of hospitalized patients with AUD and depressive symptoms. Recent data suggest that the effect size of psilocybin is much higher than other currently available treatments. However, this paradigm shift must be confirmed in our cohort of people with AUD and depressive symptoms, and in the context of treatment in addition to usual care, by an estimation of the expected effect size based on real data. This will allow the sample size to be accurately calculated for a large-scale randomized clinical trial. Finally, the potential mechanisms of action of psilocybin to prevent relapse in AUD with comorbid depression after withdrawal need to be documented. The objective of this pilot study is to evaluate the feasibility, acceptability, neural mechanisms and preliminary results of the effectiveness of psilocybin in the treatment of AUD and depressive symptoms after withdrawal, in addition to usual treatment. The study authors hypothesize that two oral administrations of 25 mg psilocybin at three-week intervals versus a control condition (1 mg psilocybin), in addition to the usual treatment, will be acceptable and feasible in recently withdrawn individuals suffering from AUD and depressive symptoms, between 14 and 60 days after their last alcohol consumption

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging medications and pharmacological treatment approaches for substance use disorders.
   Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, et al · · 2025 · cited 2× · PMID 39719161 · DOI 10.1016/j.pbb.2024.173952