Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a pilot study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]

Decision date (initial)

2026-01-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Française des Jeux (French legal obligation for gambling operators to finance scientific studies)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Assess the feasibility of conducting a randomized clinical trial on psychedelic-assisted psychotherapy for the treatment of gambling disorder, estimating the ability to retain participants until the end of the protocol.

Secondary objectives 5

1. Generate preliminary efficacy data
2. Identify the clinical factors potentially associated with the intensity of the psychedelic experience (which determines the expected therapeutic effect).
3. Conduct a preliminary assessment of the safety of the treatment under study.
4. Assess the feasibility of recruitment (ability to recruit participants for the study) and the proposed experimental protocol.
5. Evaluate the acceptability of the proposed experimental treatment (by patients and caregivers)

Conditions and MedDRA coding

Gambling disorder

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Men and women aged 18 or over
2. If taking psychotropic medication (excluding nicotine replacement therapy): dosage stabilized or treatment started more than one month ago.
3. In whom the current diagnosis of gambling disorder has been confirmed (diagnostic criteria according to DSM-5), regardless of the level of severity
4. Able to complete self-assessment questionnaires
5. Volunteers willing to start addiction treatment, or for whom the treatment already undertaken is not sufficient
6. Agreeing to a blood test and an electrocardiogram
7. Written and oral comprehension of French
8. Having signed an informed consent form prior to any procedure under consideration
9. Affiliated with a French social security system
10. Negative result in urinary toxicology screening
11. Women of childbearing age with a negative pregnancy test and highly effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7)
12. Men of childbearing age with effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7).

Exclusion criteria 15

1. Medical conditions that would prevent safe participation in the trial (epilepsy, significantly impaired liver function (TP<50%), significantly impaired kidney function (GFR<90 mL/min), coronary artery disease, history of arrhythmia, heart failure, uncontrolled hypertension, history of stroke, severe asthma, hyperthyroidism, narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder neck obstruction).
2. Major cognitive impairment (Mini-Mental State Examination score < 26)
3. Knewn allergy or hypersensitivity to psilocybin or any of the excipients contained in the experimental drug
4. Pregnancy or breastfeeding
5. Current protective measure (guardianship and judicial protection)
6. Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical progression
7. Serious ECG abnormalities (including prolongation of the QTc interval = corrected QT)
8. Current or past psychotic or bipolar disorder
9. Other unstable psychiatric disorder
10. Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder
11. High current suicide risk (according to the MINI 5.0 suicide risk module)
12. History of hallucinogen use disorder or any use in the past year
13. Current alcohol use disorder with a history of withdrawal symptoms
14. Extreme thinness (BMI < 16.5) or obesity (BMI > 30)
15. Taking inhibitors of UGT1A9, UGT1A10, ALDH, and ADH

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Protocol completion rate, defined as the proportion of randomized participants who completed all scheduled visits and procedures, including all PAP sessions/control sessions and follow-up assessments until the end of study participation.

Secondary endpoints 5

1. Changes in mean scores (+ standard deviations) or proportions, in each arm, between baseline assessment (V0) and post-treatment assessment: - Personal self-efficacy (General Self-Efficacy Scale: GSES); - Clinical Global Impression-Severity (CGI-S); - self-compassion (Self-Compassion Scale: SCS); - spirituality (WHOQOL-SRPB);- intensity, frequency, and duration of craving episodes and daily journaling.
2. Correlation between the intensity of the psychedelic experience, measured by the MEQ-30 score obtained post-administration, and the mean scores (+ standard deviations) or proportions at baseline of the following variables in the experimental arm: spirituality (WHOQOL-SRPB); self-compassion (SCS); treatment expectations (CEQ at baseline); personal self-efficacy (GSES); average dose of IMP administered during the two sessions; measurement of blind maintenance.
3. Average scores (+ standard deviations) or proportions, in each arm: of HR and BP, assessed during administration sessions; expected acute effects (17-item behavior and mood observation grid), assessed during administration sessions; number, type, severity, and attributability of AEs (excluding expected acute effects), assessed during administration sessions and throughout the study;increased risk of suicide;therapeutic index and clinical improvement.
4. Recruitment feasibility validated if the goal of participants within the planned inclusion period is achieved (CONSORT diagram ; participants continuing treatment to the end in each arm;Assessment of blind maintenance)
5. self-reported acceptability by patients and caregivers: duration, number, and frequency of sessions; reasons for refusal to participate by eligible patients and dropouts

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Benoît SCHRECK

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Benoît SCHRECK

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications