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

30. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

172

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Frankreich
      • Bayonne, Frankreich
        • Noch keine Rekrutierung
        • Centre Hospitalier de la Côte Basque
        • Kontakt:
      • Besançon, Frankreich
      • Bordeaux, Frankreich
      • Brest, Frankreich
      • Bron, Frankreich
      • Nantes, Frankreich
      • Nîmes, Frankreich, 30029
        • Rekrutierung
        • CHU de Nîmes
        • Kontakt:
      • Saint-Priest, Frankreich

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: High dose psilocybin
2 administrations of high-dose psilocybin (25 mg) 3 weeks apart
Arzneimittel: 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
Arzneimittel: Psilocybin (low dose)
2 administrations of low-dose psilocybin (3 mg) 3 weeks apart

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of relapse between groups
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sex
Zeitfenster: Tag 0
Tag 0
Change in relapse rate between groups
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 27
Yes/no
Week 27
Reason for 3rd dose request
Zeitfenster: 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
Zeitfenster: Week 28
Yes/no
Week 28
Relapse rate in relapsers between groups
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 0
The Adverse Childhood Experiences (ACE) Questionnaire
Day 0
Attachment style
Zeitfenster: Day 0
The Relationship Scale Questionnaire (RSQ) for attachment style (secure, fearful, preoccupied, dismissing)
Day 0
Severity of aocohol use disorder
Zeitfenster: Day 0
The Clinical Global Impression- Severity (CGI-S)
Day 0
Cognitive impairments
Zeitfenster: Day 0
Montreal Cognitive Assessment (MoCA)
Day 0
Features of the psychedelic experience
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 0
years
Day 0
Currently under antidepressant at the inclusion
Zeitfenster: Day 0
Yes/no
Day 0
Diagnosed with ADHD
Zeitfenster: Day 0
Yes/no
Day 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Zeitfenster: Dosing session in week 0
Dosing session in week 0
In menstruating participants, point of the menstruation cycle at psilocybin administration
Zeitfenster: Dosing session in week 3
Dosing session in week 3
In menstruating participants, point of the menstruation cycle at psilocybin administration
Zeitfenster: Dosing session in week 28 if third dose
Dosing session in week 28 if third dose
Safety and tolerance of psilocybin
Zeitfenster: End of study, week 51
List of adverse events
End of study, week 51
Change in gamma-glutamyl transferase (GGT) between groups and subgroups
Zeitfenster: At week 28 compared to baseline
fL
At week 28 compared to baseline
Change in carbohydrate-deficient transferrin (CDT) between groups and subgroups
Zeitfenster: At week 28 compared to baseline
U/L
At week 28 compared to baseline
Change in mean corpuscular volume (MCV) between groups and subgroups
Zeitfenster: At week 28 compared to baseline
Percentage
At week 28 compared to baseline
Guess the group
Zeitfenster: After dosing session Week 0
Two-item questionnaire developed from the EPIsoDE framework
After dosing session Week 0
Guess the group
Zeitfenster: After dosing session Week 3
Two-item questionnaire developed from the EPIsoDE framework
After dosing session Week 3

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Ermittler

  • Hauptermittler: Amandine Luquiens, Centre Hospitalier Universitaire de Nîmes

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Juni 2026

Primärer Abschluss (Geschätzt)

1. Juni 2030

Studienabschluss (Geschätzt)

1. Juni 2030

Studienanmeldedaten

Zuerst eingereicht

5. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

10. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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