Alcohol Use DisorderPhase 3ERPPADNCT07638553
Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms
A Phase 3 study testing Psilocybin (high dose) and Psilocybin (low dose) in people with Alcohol Use Disorder and Depressive Sympotoms, run by Centre Hospitalier Universitaire de Nīmes at 8 sites in France.
Trial summary
Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Depressive Sympotoms, Psilocybin
- What is being tested?
- Psilocybin (high dose) and Psilocybin (low dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 8 sitesFrance
- Study dates
- 30 Jun 2026to Jun 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed DSM-5 diagnosis of severe AUD.
- Scale BDI-II ((Beck Depression Inventory) ≥14
- The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient unable to give informed consent.
- Participants planning to donate sperm within three months of psilocybin administration
Show all 19Show fewer
- Positive pregnancy test at inclusion for participants of childbearing age.
- Patient who is pregnant, breastfeeding, or wishing to become pregnant during participation in the study.
- Any use of classical psychedelic in the last year
- Other current substance use disorder (except tobacco)
- Diagnosed schizophrenic or bipolar disorder
- High emotional lability (clinician-judged)
- On antipsychotics treatment that may interfere with psilocybin.
- Need for monoamine oxidase inhibitor (MAOI) treatment, which may interfere with psilocybin.
- Severe suicidal ideation (high risk on the Columbia scale)
- 1st degree family member with a diagnosed psychotic disorder
- Severe cognitive impairment (clinician-judged)
- CIWA-AR > 8
- Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function; coronary artery disease; history of arrhythmia; Abnormal QT interval prolongation (QTc > 470 ms for women and >450 ms for men); heart failure; uncontrolled hypertension (greater than 165/95 mmHg at screening); history of stroke; severe asthma; hyperthyroidism; narrow-angle glaucoma; stenosing gastroduodenal ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy or bladder neck obstruction; uncontrolled type I or type II diabetes, or a history of ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
Centre Hospitalier de la Côte Basque
Bayonne
Sophie-Athéna CHARPON, 05 59 44 42 19, sachapron@ch-cotebasque.fr
- Not yet recruiting
CHU Besançon
Besançon
Julie GIUSTNIANI, 03.81.21.90.08, jgiustiniani@chu-besancon.fr
- Not yet recruiting
CHU de Bordeaux
Bordeaux
Mélina FATSEAS, 05 47 75 75 75, melina.fatseas@u-bordeaux.fr
- Not yet recruiting
CHU Brest
Brest
Morgane GUILLOU, 02 98 34 23 48, morgane.guillou@chu-brest.fr
- Not yet recruiting
CH Le Vinatier
Bron
Benjamin ROLLAND, 04 37 91 50 75, benjamin.rolland@univ-lyon1.fr
- Not yet recruiting
CHU de Nantes
Nantes
Marie GRALL-BRONNEC, 02.40.20.66.40, marie.bronnec@chu-nantes.fr
- Recruiting
CHU de Nîmes
Nîmes, 30029
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
- Not yet recruiting
CHU Saint-Etienne
Saint-Priest
Aurélia GAY, 04 77 12 02 31, aurelia.gay@chu-st-etienne.fr
About this study
Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants.
The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 [0.16-1.65]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.
- Conditions
- Alcohol Use Disorder, Depressive Sympotoms, Psilocybin
- Being tested
- Psilocybin (high dose), Psilocybin (low dose)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (high dose)Drug
2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
Psilocybin (low dose)Drug
2 administrations of low-dose psilocybin (3 mg) 3 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| High dose psilocybin | Experimental | 2 administrations of high-dose psilocybin (25 mg) 3 weeks apart Receives: Drug: Psilocybin (high dose) |
| Low-dose psilocybin | Placebo comparator | 2 administrations of low-dose psilocybin (3 mg) 3 weeks apart Receives: Drug: Psilocybin (low dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of relapse between groups
Relapse Yes/no, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Measured: Month 6
Time to relapse between groups
Days until relapse, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Measured: Month 6
Secondary outcomes (47)
Change in relapse rate between groups
Assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rate of heavy drinking days between groups
Percent; Assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in total alcohol consumption between groups
Grams, assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in number of drinking days between groups
Days, assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in craving between groups
Assessed using the Craving Experience Questionnaire (CEQ), measuring strength and frequency of craving with a score ranging from 0 to 110, whereby a higher score denotes more craving.
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in alcohol-related quality of life between groups
Alcohol Quality of Life Scale- brief, a 7-item questionnaire assessing the negative impact of alcohol across 7 dimensions: social relationships, activities, living conditions, self-care, negative emotions, sleep, and loss of control.
Measured: At weeks 3, 15, 21, 27 compared to baseline
Change in anxiety between groups
Beck Anxiety Inventory (BAI)
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in emotional dysregulation between groups
Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rejection sensitivity between groups
Adult Rejection Sensitivity Questionnaire (A-RSQ)
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in post-Traumatic Stress Disorder between groups
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), where a score of 44 is highly sensitive to diagnose PTSD
Measured: At weeks 3, 9, 15, 21, 27 compared to baseline
Visual Perspective task (VPT)
This task allows calculation of the egocentric bias index, the altercentric bias index and the egocentric egocentric bias
Measured: Day 0
Visual Perspective task (VPT)
This task allows calculation of the egocentric bias index, the altercentric bias index and the egocentric egocentric bias
Measured: Week 3
Visual Perspective task (VPT) for participants opting for a third dose
This task allows calculation of the egocentric bias index, the altercentric bias index and the egocentric egocentric bias
Measured: Week 28
Request for a 3rd dose of psilocybin between groups
Yes/no
Measured: Week 27
Reason for 3rd dose request
Relapse in AUD/ risk of relapse in AUD/low self-efficacy/ relapse in depression/ personal development/ other
Measured: Week 27
Administration of 3rd dose
Yes/no
Measured: Week 28
Relapse rate in relapsers between groups
Assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 33, 39, 45, 51 compared to week 27
Rate of heavy drinking days in relapsers between groups
Percent; Assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 33, 39, 45, 51 compared to week 27
Total alcohol consumption in relapsers between groups
Grams, assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in number of drinking days in relapsers between groups
Days, assessed using the Timeline Follow-Back (TLFB) method
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in craving in relapsers between groups
Assessed using the Craving Experience Questionnaire (CEQ), measuring strength and frequency of craving with a score ranging from 0 to 110, whereby a higher score denotes more craving.
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in alcohol-related quality of life in relapsers between groups
Alcohol Quality of Life Scale- brief, a 7-item questionnaire assessing the negative impact of alcohol across 7 dimensions: social relationships, activities, living conditions, self-care, negative emotions, sleep, and loss of control.
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in depressive symptoms in relapsers between groups
Beck Depression Inventory-II (BDI-II). The total score is the sum of the 21 item scores, ranging from 0 to 39. Higher scores indicate greater severity of depression.
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in anxiety in relapsers between groups
Beck Anxiety Inventory (BAI)
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in emotional dysregulation in relapsers between groups
Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in rejection sensitivity in relapsers between groups
Adult Rejection Sensitivity Questionnaire (A-RSQ)
Measured: At weeks 33, 39, 45, 51 compared to week 27
Change in post-Traumatic Stress Disorder between groups
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), where a score of 44 is highly sensitive to diagnose PTSD
Measured: At weeks 33, 39, 45, 51 compared to week 27
Adverse Childhood Experiences
The Adverse Childhood Experiences (ACE) Questionnaire
Measured: Day 0
Attachment style
The Relationship Scale Questionnaire (RSQ) for attachment style (secure, fearful, preoccupied, dismissing)
Measured: Day 0
Severity of aocohol use disorder
The Clinical Global Impression- Severity (CGI-S)
Measured: Day 0
Cognitive impairments
Montreal Cognitive Assessment (MoCA)
Measured: Day 0
Features of the psychedelic experience
Acceptance/Avoidance Promoting Experience Questionnaire (APEQ)
Measured: Prior to integration session in Week 0
Features of the psychedelic experience
Acceptance/Avoidance Promoting Experience Questionnaire (APEQ)
Measured: Prior to integration session in Week 3
Features of the psychedelic experience
Acceptance/Avoidance Promoting Experience Questionnaire (APEQ)
Measured: Prior to integration session in Week 28 if third dose
Age
years
Measured: Day 0
Sex
Measured: Day 0
Currently under antidepressant at the inclusion
Yes/no
Measured: Day 0
Diagnosed with ADHD
Yes/no
Measured: Day 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Measured: Dosing session in week 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Measured: Dosing session in week 3
In menstruating participants, point of the menstruation cycle at psilocybin administration
Measured: Dosing session in week 28 if third dose
Safety and tolerance of psilocybin
List of adverse events
Measured: End of study, week 51
Change in gamma-glutamyl transferase (GGT) between groups and subgroups
fL
Measured: At week 28 compared to baseline
Change in carbohydrate-deficient transferrin (CDT) between groups and subgroups
U/L
Measured: At week 28 compared to baseline
Change in mean corpuscular volume (MCV) between groups and subgroups
Percentage
Measured: At week 28 compared to baseline
Guess the group
Two-item questionnaire developed from the EPIsoDE framework
Measured: After dosing session Week 0
Guess the group
Two-item questionnaire developed from the EPIsoDE framework
Measured: After dosing session Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start30 Jun 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine Luquiens, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638553
- Sponsor's protocol ID
- PHRC-N/2024/AL-01
- Other IDs
- 2025-525069-65-00, 2025
- Acronym
- ERPPAD
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms
- ClinicalTrials.gov ID
- NCT07638553
- Acronym / sponsor ID
- ERPPAD / PHRC-N/2024/AL-01
- Conditions
- Alcohol Use Disorder, Depressive Sympotoms, Psilocybin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants.
The Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 [0.16-1.65]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose psilocybin | Experimental | Drug: Psilocybin (high dose)2 administrations of high-dose psilocybin (25 mg) 3 weeks apart |
| Low-dose psilocybin | Placebo comparator | Drug: Psilocybin (low dose)2 administrations of low-dose psilocybin (3 mg) 3 weeks apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed DSM-5 diagnosis of severe AUD.
- Scale BDI-II ((Beck Depression Inventory) ≥14
- The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
Key exclusion criteria (19 listed)
- The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (high dose)2 administrations of high-dose psilocybin (25 mg) 3 weeks apart | Drug | High dose psilocybin |
| Psilocybin (low dose)2 administrations of low-dose psilocybin (3 mg) 3 weeks apart | Drug | Low-dose psilocybin |
Primary outcome
Incidence of relapse between groups
Time frame: Month 6
Relapse Yes/no, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Time to relapse between groups
Time frame: Month 6
Days until relapse, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
47 secondary outcomes
Change in relapse rate between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rate of heavy drinking days between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in total alcohol consumption between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in number of drinking days between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in craving between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in alcohol-related quality of life between groups
Time frame: At weeks 3, 15, 21, 27 compared to baseline
Change in anxiety between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in emotional dysregulation between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rejection sensitivity between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Change in post-Traumatic Stress Disorder between groups
Time frame: At weeks 3, 9, 15, 21, 27 compared to baseline
Visual Perspective task (VPT)
Time frame: Day 0
Visual Perspective task (VPT)
Time frame: Week 3
Visual Perspective task (VPT) for participants opting for a third dose
Time frame: Week 28
Request for a 3rd dose of psilocybin between groups
Time frame: Week 27
Reason for 3rd dose request
Time frame: Week 27
Administration of 3rd dose
Time frame: Week 28
Relapse rate in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Rate of heavy drinking days in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Total alcohol consumption in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in number of drinking days in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in craving in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in alcohol-related quality of life in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in depressive symptoms in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in anxiety in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in emotional dysregulation in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in rejection sensitivity in relapsers between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Change in post-Traumatic Stress Disorder between groups
Time frame: At weeks 33, 39, 45, 51 compared to week 27
Adverse Childhood Experiences
Time frame: Day 0
Attachment style
Time frame: Day 0
Severity of aocohol use disorder
Time frame: Day 0
Cognitive impairments
Time frame: Day 0
Features of the psychedelic experience
Time frame: Prior to integration session in Week 0
Features of the psychedelic experience
Time frame: Prior to integration session in Week 3
Features of the psychedelic experience
Time frame: Prior to integration session in Week 28 if third dose
Age
Time frame: Day 0
Sex
Time frame: Day 0
Currently under antidepressant at the inclusion
Time frame: Day 0
Diagnosed with ADHD
Time frame: Day 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Time frame: Dosing session in week 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Time frame: Dosing session in week 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amandine Luquiens principal investigator
Centre Hospitalier Universitaire de Nīmes
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Psilocybin (high dose) and Psilocybin (low dose) in people with Alcohol Use Disorder and Depressive Sympotoms, run by Centre Hospitalier Universitaire de Nīmes at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine Luquiens (04.66.68.69.98, amandine.luquiens@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of relapse between groups (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.