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Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms (ERPPAD)

30. juni 2026 opdateret af: Centre Hospitalier Universitaire de Nīmes

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

172

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Bayonne, Frankrig
        • Ikke rekrutterer endnu
        • Centre Hospitalier de la Côte Basque
        • Kontakt:
      • Besançon, Frankrig
      • Bordeaux, Frankrig
      • Brest, Frankrig
      • Bron, Frankrig
      • Nantes, Frankrig
      • Nîmes, Frankrig, 30029
        • Rekruttering
        • CHU de Nîmes
        • Kontakt:
      • Saint-Priest, Frankrig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: High dose psilocybin
2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
Medicin: Psilocybin (high dose)
2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
Placebo komparator: Low-dose psilocybin
2 administrations of low-dose psilocybin (3 mg) 3 weeks apart
Medicin: Psilocybin (low dose)
2 administrations of low-dose psilocybin (3 mg) 3 weeks apart

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of relapse between groups
Tidsramme: Month 6
Relapse Yes/no, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Month 6
Time to relapse between groups
Tidsramme: Month 6
Days until relapse, where relapse is defined as the 1st heavy drinking day, assessed using the Timeline Follow-Back (TLFB) method
Month 6

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Køn
Tidsramme: Dag 0
Dag 0
Change in relapse rate between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Assessed using the Timeline Follow-Back (TLFB) method
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rate of heavy drinking days between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Percent; Assessed using the Timeline Follow-Back (TLFB) method
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in total alcohol consumption between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Grams, assessed using the Timeline Follow-Back (TLFB) method
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in number of drinking days between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Days, assessed using the Timeline Follow-Back (TLFB) method
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in craving between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
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.
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in alcohol-related quality of life between groups
Tidsramme: At weeks 3, 15, 21, 27 compared to baseline
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.
At weeks 3, 15, 21, 27 compared to baseline
Change in anxiety between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Beck Anxiety Inventory (BAI)
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in emotional dysregulation between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in rejection sensitivity between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Adult Rejection Sensitivity Questionnaire (A-RSQ)
At weeks 3, 9, 15, 21, 27 compared to baseline
Change in post-Traumatic Stress Disorder between groups
Tidsramme: At weeks 3, 9, 15, 21, 27 compared to baseline
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), where a score of 44 is highly sensitive to diagnose PTSD
At weeks 3, 9, 15, 21, 27 compared to baseline
Visual Perspective task (VPT)
Tidsramme: Day 0
This task allows calculation of the egocentric bias index, the altercentric bias index and the egocentric egocentric bias
Day 0
Visual Perspective task (VPT)
Tidsramme: Week 3
This task allows calculation of the egocentric bias index, the altercentric bias index and the egocentric egocentric bias
Week 3
Visual Perspective task (VPT) for participants opting for a third dose
Tidsramme: Week 28
This task allows calculation of the egocentric bias index, the altercentric bias index and the egocentric egocentric bias
Week 28
Request for a 3rd dose of psilocybin between groups
Tidsramme: Week 27
Yes/no
Week 27
Reason for 3rd dose request
Tidsramme: Week 27
Relapse in AUD/ risk of relapse in AUD/low self-efficacy/ relapse in depression/ personal development/ other
Week 27
Administration of 3rd dose
Tidsramme: Week 28
Yes/no
Week 28
Relapse rate in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Assessed using the Timeline Follow-Back (TLFB) method
At weeks 33, 39, 45, 51 compared to week 27
Rate of heavy drinking days in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Percent; Assessed using the Timeline Follow-Back (TLFB) method
At weeks 33, 39, 45, 51 compared to week 27
Total alcohol consumption in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Grams, assessed using the Timeline Follow-Back (TLFB) method
At weeks 33, 39, 45, 51 compared to week 27
Change in number of drinking days in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Days, assessed using the Timeline Follow-Back (TLFB) method
At weeks 33, 39, 45, 51 compared to week 27
Change in craving in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
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.
At weeks 33, 39, 45, 51 compared to week 27
Change in alcohol-related quality of life in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
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.
At weeks 33, 39, 45, 51 compared to week 27
Change in depressive symptoms in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
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.
At weeks 33, 39, 45, 51 compared to week 27
Change in anxiety in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Beck Anxiety Inventory (BAI)
At weeks 33, 39, 45, 51 compared to week 27
Change in emotional dysregulation in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Difficulties in Emotion Regulation Scale (DERS), a 36-item questionnaire
At weeks 33, 39, 45, 51 compared to week 27
Change in rejection sensitivity in relapsers between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Adult Rejection Sensitivity Questionnaire (A-RSQ)
At weeks 33, 39, 45, 51 compared to week 27
Change in post-Traumatic Stress Disorder between groups
Tidsramme: At weeks 33, 39, 45, 51 compared to week 27
Post-Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), where a score of 44 is highly sensitive to diagnose PTSD
At weeks 33, 39, 45, 51 compared to week 27
Adverse Childhood Experiences
Tidsramme: Day 0
The Adverse Childhood Experiences (ACE) Questionnaire
Day 0
Attachment style
Tidsramme: Day 0
The Relationship Scale Questionnaire (RSQ) for attachment style (secure, fearful, preoccupied, dismissing)
Day 0
Severity of aocohol use disorder
Tidsramme: Day 0
The Clinical Global Impression- Severity (CGI-S)
Day 0
Cognitive impairments
Tidsramme: Day 0
Montreal Cognitive Assessment (MoCA)
Day 0
Features of the psychedelic experience
Tidsramme: Prior to integration session in Week 0
Acceptance/Avoidance Promoting Experience Questionnaire (APEQ)
Prior to integration session in Week 0
Features of the psychedelic experience
Tidsramme: Prior to integration session in Week 3
Acceptance/Avoidance Promoting Experience Questionnaire (APEQ)
Prior to integration session in Week 3
Features of the psychedelic experience
Tidsramme: Prior to integration session in Week 28 if third dose
Acceptance/Avoidance Promoting Experience Questionnaire (APEQ)
Prior to integration session in Week 28 if third dose
Age
Tidsramme: Day 0
years
Day 0
Currently under antidepressant at the inclusion
Tidsramme: Day 0
Yes/no
Day 0
Diagnosed with ADHD
Tidsramme: Day 0
Yes/no
Day 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Tidsramme: Dosing session in week 0
Dosing session in week 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Tidsramme: Dosing session in week 3
Dosing session in week 3
In menstruating participants, point of the menstruation cycle at psilocybin administration
Tidsramme: Dosing session in week 28 if third dose
Dosing session in week 28 if third dose
Safety and tolerance of psilocybin
Tidsramme: End of study, week 51
List of adverse events
End of study, week 51
Change in gamma-glutamyl transferase (GGT) between groups and subgroups
Tidsramme: At week 28 compared to baseline
fL
At week 28 compared to baseline
Change in carbohydrate-deficient transferrin (CDT) between groups and subgroups
Tidsramme: At week 28 compared to baseline
U/L
At week 28 compared to baseline
Change in mean corpuscular volume (MCV) between groups and subgroups
Tidsramme: At week 28 compared to baseline
Percentage
At week 28 compared to baseline
Guess the group
Tidsramme: After dosing session Week 0
Two-item questionnaire developed from the EPIsoDE framework
After dosing session Week 0
Guess the group
Tidsramme: After dosing session Week 3
Two-item questionnaire developed from the EPIsoDE framework
After dosing session Week 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Efterforskere

  • Ledende efterforsker: Amandine Luquiens, Centre Hospitalier Universitaire De Nimes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2030

Studieafslutning (Anslået)

1. juni 2030

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PHRC-N/2024/AL-01
  • 2025-525069-65-00 (Ctis)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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