Alcohol-Related DisordersPADNCT06235411
Psilocybin in Alcohol Use Disorder With Comorbid Depression
A study testing Psilocybin therapy, Inactive Psilocybin therapy and Electroencephalogram in people with Alcohol-Related Disorders and Depressive Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-Related Disorders, Depressive Disorder, Addiction
- What is being tested?
- Psilocybin therapy, Inactive Psilocybin therapy and Electroencephalogram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient with a confirmed DSM-5 diagnosis of severe alcohol use disorder.
- BDI II (Beck Depression Inventory) score ≥ 14.
- Last alcohol consumption must have occurred between 60 and 14 days prior to study inclusion. The patient must have had at least one heavy drinking day during the last period of alcohol consumption.
- NB: The last period of alcohol consumption prior to inclusion is defined as the last 4 weeks counted from the last drink.
- Patient with free and informed consent.
- The patient must be a member or beneficiary of a health insurance plan
Who cannot join
- The subject is participating in an interventional study involving a drug or in a clinical trial according to the REC.
- The subject is in a period of exclusion determined by a previous study
- The subject unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Schizophrenic disorder, or any history of psychotic disorder according to the clinician's judgment.
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- Past or current manic or hypomanic episode.
- Need for antipsychotic treatment that may interfere with psilocybin.
- Need for treatment with monoamine oxidase inhibitors (MAOIs) which may interfere with psilocybin.
- Current scripted suicidal ideation (according to clinician judgment) corresponding to a "high risk" score on the Columbia-Suicide Severity Rating Scale (C-SSRS).
- First-degree family member diagnosed with psychotic disorder or bipolar disorder type 1.
- High risk of negative emotional or behavioral response based on the investigator's clinical judgment (e.g., signs of serious personality disorders, antisocial behavior, severe current stressors, lack of meaningful social support)
- Patient with dementia or severe cognitive impairment (as judged by the clinician).
- CIWA-R score ≥ 8.
- Medical conditions that would prevent safe participation in the trial; for example: seizure disorders, significant impairment of liver function, coronary heart disease, history of arrhythmia, heart failure, uncontrolled hypertension (greater than 165/95 mmHg at screening), history of stroke, severe asthma, hyperthyroidism, narrow-angle glaucoma, stenotic peptic ulcer, pyloroduodenal obstruction, symptomatic enlarged prostate or bladder neck obstruction), Uncontrolled type I or type II diabetes or history of ketoacidosis, hyperglycemic coma or severe hypoglycemia with loss of conscience
- History of hallucinogen use disorder, any use in the past year or >25 lifetime uses.
- Dependence on cocaine, psychostimulants, opioids or cannabis (last 12 months).
- Current non-medical use of cocaine, psychostimulants or opioids (past 30 days).
- Serious ECG abnormalities (e.g., signs of ischemia, myocardial infarction, QTc prolongation (QTc > 0.45 seconds for men, QTc > 0.47 seconds for women).
- Hypersensitivity to the active ingredient or excipients
- No access to email.
- Insufficient understanding of French to complete the questionnaires.
- Patient for whom it is impossible to provide informed information.
- Pregnant or breastfeeding patient.
- Patient planning a pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Alcohol-Related Disorders, Depressive Disorder, Addiction
- Being tested
- Psilocybin therapy, Inactive Psilocybin therapy, Electroencephalogram, Blood samples for the analysis of immune and inflammatory profiles, stool samples
- Keywords
- Psilocybin, Psychedelic assisted therapy
- Medical subject headings
- Alcohol-Related Disorders, Depressive Disorder, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin therapyDrug
Two administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones.
One 25 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later.
The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual).
Inactive Psilocybin therapyDrug
Two administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones.
One 1 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later.
The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual).
ElectroencephalogramOther
- Rest EEG prior to first treatment administration
- EEG during first treatment administration
- Rest EEG during integration session after second treatment administration
Blood samples for the analysis of immune and inflammatory profilesOther
Three 7ml EDTA tubes will be taken in the morning on an empty stomach at day 0 and at 3 weeks.
stool samplesOther
Stool sampling at day 0 and 3 weeks Analysis of intestinal microbiota is carried out on a stool sample, which is stored at -20°C for a maximum of 24 hours. The sample is then transferred cold to the CRB of the Nîmes University Hospital, where it is stored at -80°C until the microbiology laboratory can perform a group analysis.
MRI functional and cerebralOther
MRI functional and cerebral at day 0 and 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Psilocybin therapy; Other: Electroencephalogram; Other: Blood samples for the analysis of immune and inflammatory profiles; Other: stool samples; Other: MRI functional and cerebral |
| Control group | Placebo comparator | Not described Receives: Drug: Inactive Psilocybin therapy; Other: Electroencephalogram; Other: Blood samples for the analysis of immune and inflammatory profiles; Other: stool samples; Other: MRI functional and cerebral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention between groups
Number of patients who completed both sessions
Measured: After 2nd experimental session (Week 4)
Secondary outcomes (76)
Feasibility of recruitment between groups
Number of patients screened per month/number of patients included per month.
Measured: 18 Months
Feasibility of retainment between groups
Average time (days) between screening and inclusion.
Measured: 18 Months
Feasibility of the trial between groups
Rate (%) of eligible patients who are included in the study.
Measured: 18 Months
Feasibility of randomization between groups
Rate (%) of patients included who had at least one treatment administration session
Measured: 18 Months
Feasibility of inclusion between groups
Rate (%) of assessment sessions that were completed.
Measured: 18 Months
Feasibility of therapeutic intervention between groups
Duration of assessment sessions (minutes).
Measured: 18 Months
Study acceptability between groups
Number of patients leaving the study prematurely for any reason.
Measured: 18 Months
Patient-reported reasons for abandoning the study between groups
Qualitative description of reasons cited by patients
Measured: 18 Months
Decrease in alcohol consumption between groups
Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
Measured: Day 0
Decrease in alcohol consumption between groups
Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
Measured: Week 6 (or discharge if it takes place later)
Decrease in alcohol consumption between groups
Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
Measured: Week 12
Total alcohol consumption between groups
Total alcohol consumption during previous 4 weeks
Measured: Day 0
Total alcohol consumption between groups
Total alcohol consumption during previous 4 weeks
Measured: Week 6 (or discharge if it takes place later)
Total alcohol consumption between groups
Total alcohol consumption during previous 4 weeks
Measured: Week 12
Time before first drink
Days
Measured: Day 0
Time before first drink
Days
Measured: Week 6 (or discharge if it takes place later)
Time before first drink
Days
Measured: Week 12
Time to first day of heavy drinking
Days
Measured: Day 0
Time to first day of heavy drinking
Days
Measured: Week 6 (or discharge if it takes place later)
Time to first day of heavy drinking
Days
Measured: Week 12
Craving between groups
Craving Experience Questionnaire (CEQ) score; the CEQ evaluates intensity and frequency of craving from 11 intensity items in blocks a-c. Each item is rated between 0 ("Not at all") and 10 ("Extremely") for a total score between 0 and 110. The higher the score, the more intense the craving. A frequency of craving score is calculated by adding the values obtained from 11 items in blocks d-f. Each item is rated between 0 ("Never") and 10 ("Constantly") for a total craving frequency score between 0 and 110.
Measured: Day 0
Craving between groups
Craving Experience Questionnaire (CEQ) score; the CEQ evaluates intensity and frequency of craving from 11 intensity items in blocks a-c. Each item is rated between 0 ("Not at all") and 10 ("Extremely") for a total score between 0 and 110. The higher the score, the more intense the craving. A frequency of craving score is calculated by adding the values obtained from 11 items in blocks d-f. Each item is rated between 0 ("Never") and 10 ("Constantly") for a total craving frequency score between 0 and 110.
Measured: Week 12
Quality of life between groups
Alcohol quality of life scale (AQoLS); the 34-item questionnaire measures the negative impact of the relationship with alcohol on quality of life through 7 dimensions: social relationships, activities, living conditions, etc. self-care, negative emotions, sleep and loss of control on a scale of 0 (not at all) to 3 (very much), for a total score of 102. There is no threshold value.
Measured: Day 0
Quality of life between groups
Alcohol quality of life scale (AQoLS); the 34-item questionnaire measures the negative impact of the relationship with alcohol on quality of life through 7 dimensions: social relationships, activities, living conditions, etc. self-care, negative emotions, sleep and loss of control on a scale of 0 (not at all) to 3 (very much), for a total score of 102. There is no threshold value.
Measured: Week 12
Depression between groups
Beck Depression Inventory (BDI II); a 21-item scale. Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity of a symptom, rated from 0 to 3. Only the highest rating chosen for a given series is retained. The total score ranges from 0 to 39; with a higher score indicating greater intensity of depression.
Measured: Day 0
Depression between groups
Beck Depression Inventory (BDI II); a 21-item scale. Each item consists of 4 sentences corresponding to 4 degrees of increasing intensity of a symptom, rated from 0 to 3. Only the highest rating chosen for a given series is retained. The total score ranges from 0 to 39; with a higher score indicating greater intensity of depression.
Measured: Week 12
Anxiety between groups
Beck Anxiety Inventory (BAI); a 21-question score of common symptoms of anxiety, such as numbness and tingling, and sweating. Responses are rated on a scale of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. Thresholds are: 0-7: Minimal; 8-15: Light; 16-25: Moderate; 26-63: Severe.
Measured: Day 0
Anxiety between groups
Beck Anxiety Inventory (BAI); a 21-question score of common symptoms of anxiety, such as numbness and tingling, and sweating. Responses are rated on a scale of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. Thresholds are: 0-7: Minimal; 8-15: Light; 16-25: Moderate; 26-63: Severe.
Measured: Week 12
Emotion regulation difficulties between groups
Difficulties in Emotion Regulation Scale (DERS); a 36-item questionnaire assessing multiple aspects of emotion dysregulation. The measure gives a total score and six subscores:1. Non-acceptance of emotional responses (NON-ACCEPTANCE); 2. Difficulties in adopting goal-oriented behavior (GOALS); 3. Difficulty controlling impulses (IMPULSE); 4. Lack of emotional awareness (AWARENESS); 5. Limited access to emotion regulation strategies (STRATEGIES); 6. Lack of emotional clarity (CLARITY), with a final score 0-100.
Measured: Day 0
Emotion regulation difficulties between groups
Difficulties in Emotion Regulation Scale (DERS); a 36-item questionnaire assessing multiple aspects of emotion dysregulation. The measure gives a total score and six subscores:1. Non-acceptance of emotional responses (NON-ACCEPTANCE); 2. Difficulties in adopting goal-oriented behavior (GOALS); 3. Difficulty controlling impulses (IMPULSE); 4. Lack of emotional awareness (AWARENESS); 5. Limited access to emotion regulation strategies (STRATEGIES); 6. Lack of emotional clarity (CLARITY), with a final score 0-100.
Measured: Week 12
Rejection sensitivity between groups
Adult Rejection Sensitivity Questionnaire (A-RSQ); rejection sensitivity score calculated for 9 situations by multiplying the level of rejection concern by the level of rejection expectation. The total rejection sensitivity score is the average of the rejection sensitivity scores for the 9 situations.
Measured: Day 0
Rejection sensitivity between groups
Adult Rejection Sensitivity Questionnaire (A-RSQ); rejection sensitivity score calculated for 9 situations by multiplying the level of rejection concern by the level of rejection expectation. The total rejection sensitivity score is the average of the rejection sensitivity scores for the 9 situations.
Measured: Week 12
Meaning in life between groups
Meaning in Life Questionnaire (MLQ); a 10-item score assessing two dimensions of meaning in life rated on a seven-point scale ranging from "absolutely true" to "absolutely false." The "Presence of Meaning" subscale measures the extent to which respondents believe their lives have meaning. The "Search for Meaning" subscale measures respondents' engagement and motivation in their efforts to find meaning or deepen their understanding of the meaning of their lives, with a final score of 5-35
Measured: Day 0
Meaning in life between groups
Meaning in Life Questionnaire (MLQ); a 10-item score assessing two dimensions of meaning in life rated on a seven-point scale ranging from "absolutely true" to "absolutely false." The "Presence of Meaning" subscale measures the extent to which respondents believe their lives have meaning. The "Search for Meaning" subscale measures respondents' engagement and motivation in their efforts to find meaning or deepen their understanding of the meaning of their lives, with a final score of 5-35
Measured: Week 3
Meaning in life between groups
Meaning in Life Questionnaire (MLQ); a 10-item score assessing two dimensions of meaning in life rated on a seven-point scale ranging from "absolutely true" to "absolutely false." The "Presence of Meaning" subscale measures the extent to which respondents believe their lives have meaning. The "Search for Meaning" subscale measures respondents' engagement and motivation in their efforts to find meaning or deepen their understanding of the meaning of their lives, with a final score of 5-35
Measured: Week 6
Meaning in life between groups
Meaning in Life Questionnaire (MLQ); a 10-item score assessing two dimensions of meaning in life rated on a seven-point scale ranging from "absolutely true" to "absolutely false." The "Presence of Meaning" subscale measures the extent to which respondents believe their lives have meaning. The "Search for Meaning" subscale measures respondents' engagement and motivation in their efforts to find meaning or deepen their understanding of the meaning of their lives, with a final score of 5-35
Measured: Week 12
Cognitive functioning between groups
Conflict indices and task focus of the Visual Perspective Task (VPT); participants evaluate either the number of red dots that in a scene from their own point of view (self-perspective condition), or the number of dots that another no one present in the scene can see (self-perspective condition).
Measured: Day 0
Cognitive functioning between groups
Conflict indices and task focus of the Visual Perspective Task (VPT); participants evaluate either the number of red dots that in a scene from their own point of view (self-perspective condition), or the number of dots that another no one present in the scene can see (self-perspective condition).
Measured: Second psilocybin session (Week 4)
Role of cognitive function at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Montreal Cognitive Assessment (MoCA); measuring attention, concentration, executive functions, memory, language, visuoconstructive abilities, abstraction abilities, calculation and orientation. Score 0-30.
Measured: Day 0
Role of Posttraumatic Stress Disorder at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), a 17-item scale assessing the intensity of 17 PTSD symptoms. Each question is rated between 1 and 5 depending on the intensity and frequency of symptoms over the previous month. Three scales: Intrusion (items 1 to 5); Avoidance (items 6 to 12); Hyperstimulation (items 13 to 17). Total score 17-85, with threshold of 44 for PTSD diagnosis.
Measured: Day 0
Role of attachment at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
RSQ (Relationship Scale Questionnaire); a 30-item questionnaire classifying into four categories of attachment (secure or autonomous, avoidant or detached, preoccupied or ambivalent, fearful or disorganized). Score 13-65.
Measured: Day 0
Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitors
Concomitant Selective serotonin reuptake inhibitors yes/no
Measured: Day 0
Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitors
Concomitant Selective serotonin reuptake inhibitors yes/no
Measured: Week 3
Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitors
Concomitant Selective serotonin reuptake inhibitors yes/no
Measured: Week 6
Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitorsof other treatments on change in the percentage of heavy drinking days in preceding 4 weeks
Concomitant Selective serotonin reuptake inhibitors yes/no
Measured: Week 12
Role of the patient-reported quality of the hallucinogenic experience on change in the percentage of heavy drinking days in preceding 4 weeks
5D-ASC (5-Dimensional Altered States of Consciousness Questionnaire) dimension score after psilocybin sessions. A 94-item questionnaire (to be translated and retrotranslated) administered 5 to 6 hours after drug administration; visual analog scale of five main dimensions: "The absence of oceanic boundaries", "fear of ego dissolution", "restructuring of vision", "auditory alterations" and "reduction of vigilance".
Measured: End of 1st psilocybin session (Week 1)
Role of the patient-reported quality of the hallucinogenic experience on change in the percentage of heavy drinking days in preceding 4 weeks
5D-ASC (5-Dimensional Altered States of Consciousness Questionnaire) dimension score after psilocybin sessions. A 94-item questionnaire (to be translated and retrotranslated) administered 5 to 6 hours after drug administration; visual analog scale of five main dimensions: "The absence of oceanic boundaries", "fear of ego dissolution", "restructuring of vision", "auditory alterations" and "reduction of vigilance".
Measured: End of 2nd psilocybin session (Week 4)
Role of the quality of the hallucinogenic experience according to brain activity on change in the percentage of heavy drinking days in preceding 4 weeks
Electroencephalogram parameters: alpha coherence in the resting state
Measured: Before 1st experimental session (Week 1)
Role of the quality of the hallucinogenic experience according to brain activity on change in the percentage of heavy drinking days in preceding 4 weeks
Electroencephalogram parameters: alpha coherence in the resting state
Measured: During the 1st experimental session (Week 1)
Role of the quality of the hallucinogenic experience according to brain activity on change in the percentage of heavy drinking days in preceding 4 weeks
Electroencephalogram parameters: alpha coherence in the resting state
Measured: Day after 2nd experimental session (Week 4)
Change in the percentage of heavy drinking days in preceding 4 weeks according to the quality of the hallucinogenic experience
Hallucinogenic experience assessed through qualitative analysis of audio-recorded verbatim of the integration session.
Measured: Day after 1st experimental session (Week 1)
Change in the percentage of heavy drinking days in preceding 4 weeks according to the quality of the hallucinogenic experience
Hallucinogenic experience assessed through qualitative analysis of audio-recorded verbatim of the integration session.
Measured: Day after 2nd experimental session (Week 4)
immune profiles through the microbiota
Evaluate participants' immune profiles in both groups through the microbiota before the first dose with circulating 16sDNA assay.
Measured: day 0
Evolution immune profiles through the microbiota
Evaluate the evolution of the immune profiles of participants in both groups through the microbiota before the first dose with circulating 16sDNA assay.
Measured: day 0
Immune and inflammatory profiles using cerebral structural and functional MRI
Evaluate the immune and inflammatory profiles in the 2 groups using cerebral structural and functional MRI prior to the first psilocybin administration.
Measured: day 0
Immune and inflammatory profiles using cerebral structural and functional MRI
Evaluate the immune and inflammatory profiles in the 2 groups using cerebral structural and functional MRI 3 weeks after to the first psilocybin administration.
Measured: week 3
Evolution of Immune and inflammatory profiles using cerebral structural and functional MRI
Evaluate the evolution of the immune and inflammatory profiles in the 2 groups using cerebral structural and functional MRI to the first psilocybin administration.
Measured: day 0
Evolution of Immune and inflammatory profiles using cerebral structural and functional MRI
Evaluate the evolution of the immune and inflammatory profiles in the 2 groups using cerebral structural and functional MRI 3 weeks after to the first psilocybin administration.
Measured: week 3
immune profiles through the microbiota
Evaluate participants' immune profiles in both groups through the microbiota before the first dose with circulating 16sDNA assay.
Measured: week 3
Evolution immune profiles through the microbiota
Evaluate the evolution of the immune profiles of participants in both groups through the microbiota before the first dose with circulating 16sDNA assay.
Measured: week 3
Inflammatory profiles by measuring the cytokine TNF alpha in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine TNF alpha before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: day 0
Inflammatory profiles by measuring the cytokine TNF alpha in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine TNF alpha before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours. Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: week 3
analysis of intestinal microbiota : Number of species detected in the intestinal microbiota
Patients will provide a stool sample, stored at -20°C and transported in an insulated bag to the hospital. The sample will be frozen at -80°C. The number of species detected in the intestinal microbiota will be recorded
Measured: day 0
analysis of intestinal microbiota : Number of species detected in the intestinal microbiota
Patients will provide a stool sample, stored at -20°C and transported in an insulated bag to the hospital. The sample will be frozen at -80°C. The number of species detected in the intestinal microbiota will be recorded
Measured: week 3
analysis of intestinal microbiota : Distribution of species detected in the intestinal microbiota.
Patients will provide a stool sample, stored at -20°C and transported in an insulated bag to the hospital. The sample will be frozen at -80°C. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded
Measured: day 0
analysis of intestinal microbiota : Distribution of species detected in the intestinal microbiota.
Patients will provide a stool sample, stored at -20°C and transported in an insulated bag to the hospital. The sample will be frozen at -80°C. The distribution of the various bacterial species detected in the intestinal microbiota will be recorded
Measured: week 3
analysis of intestinal microbiota : Diversity of species detected in the intestinal microbiota.
Patients will provide a stool sample, stored at -20°C and transported in an insulated bag to the hospital. The sample will be frozen at -80°C. The diversity index according to the number of species will be recorded
Measured: day 0
analysis of intestinal microbiota : Diversity of species detected in the intestinal microbiota.
Patients will provide a stool sample, stored at -20°C and transported in an insulated bag to the hospital. The sample will be frozen at -80°C. The diversity index according to the number of species will be recorded
Measured: week 3
Inflammatory profiles by measuring the cytokine IL-1b in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-1b before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: day 0
Inflammatory profiles by measuring the cytokine IL-1b in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-1b before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: week 3
Inflammatory profiles by measuring the cytokine IL-6 in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-6 before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: day 0
Inflammatory profiles by measuring the cytokine IL-6 in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-6 before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: week 3
Inflammatory profiles by measuring the cytokine IL-8 in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-8 before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: day 0
Inflammatory profiles by measuring the cytokine IL-8 in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-8 before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: week 3
Inflammatory profiles by measuring the cytokine IL-10 in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-10 before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: day 0
Inflammatory profiles by measuring the cytokine IL-10 in plasma
Evaluate participants' inflammatory profiles in both groups through cytokine IL-10 before the first dose. A tube of blood will be taken. The sample is transported to the laboratory at room temperature within 4 hours.
Tubes are then centrifuged at 2000g for 10 min at room temperature, then aliquoted by 500µL into 1.5 mL Eppendorf LoBind Protein tubes for storage at -80°C prior to batch analysis.
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start5 Feb 2024
- Primary completion19 Nov 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine Luquiens, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235411
- Sponsor's protocol ID
- IRESP/2022/AL-01
- Acronym
- PAD
- Status last verified
- Mar 2025
- First submitted
- 8 Jan 2024
- Last updated
- 19 Mar 2025
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin in Alcohol Use Disorder With Comorbid Depression
- ClinicalTrials.gov ID
- NCT06235411
- Acronym / sponsor ID
- PAD / IRESP/2022/AL-01
- Conditions
- Alcohol-Related Disorders, Depressive Disorder, Addiction
- Keywords
- Psilocybin, Psychedelic assisted therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 31 Jan 2024 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Psilocybin therapy, Other: Electroencephalogram, Other: Blood samples for the analysis of immune and inflammatory profiles, Other: stool samples, Other: MRI functional and cerebral |
| Control group | Placebo comparator | Drug: Inactive Psilocybin therapy, Other: Electroencephalogram, Other: Blood samples for the analysis of immune and inflammatory profiles, Other: stool samples, Other: MRI functional and cerebral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with a confirmed DSM-5 diagnosis of severe alcohol use disorder.
- BDI II (Beck Depression Inventory) score ≥ 14.
- Last alcohol consumption must have occurred between 60 and 14 days prior to study inclusion. The patient must have had at least one heavy drinking day during the last period of alcohol consumption.
- NB: The last period of alcohol consumption prior to inclusion is defined as the last 4 weeks counted from the last drink.
- Patient with free and informed consent.
Key exclusion criteria (25 listed)
- The subject is participating in an interventional study involving a drug or in a clinical trial according to the REC.
- The subject is in a period of exclusion determined by a previous study
- The subject unable to express consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
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 therapyTwo administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones. One 25 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later. The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual). | Drug | Experimental group |
| Inactive Psilocybin therapyTwo administrations of psilocybin given 3 weeks apart. The treatment day will begin around 9 a.m. with a brief interview. Patients will be invited to relax and music will be played through speakers and headphones. One 1 mg capsule of Psilocybin will be given approximately 30 minutes to 1.5 hours later. The patient is accompanied throughout the session (minimum 6 hours depending on the effects felt). The patient will benefit from a preparation session the day before dosing, and an integration session the day after. Intensive relapse prevention program will be dispensed between the 2 dosing sessions (treatment as usual). | Drug | Control group |
| Electroencephalogram* Rest EEG prior to first treatment administration * EEG during first treatment administration * Rest EEG during integration session after second treatment administration | Other | Control group, Experimental group |
| Blood samples for the analysis of immune and inflammatory profilesThree 7ml EDTA tubes will be taken in the morning on an empty stomach at day 0 and at 3 weeks. | Other | Control group, Experimental group |
| stool samplesStool sampling at day 0 and 3 weeks Analysis of intestinal microbiota is carried out on a stool sample, which is stored at -20°C for a maximum of 24 hours. The sample is then transferred cold to the CRB of the Nîmes University Hospital, where it is stored at -80°C until the microbiology laboratory can perform a group analysis. | Other | Control group, Experimental group |
| MRI functional and cerebralMRI functional and cerebral at day 0 and 3 weeks | Other | Control group, Experimental group |
Primary outcome
Feasibility of the intervention between groups
Time frame: After 2nd experimental session (Week 4)
Number of patients who completed both sessions
76 secondary outcomes
Feasibility of recruitment between groups
Time frame: 18 Months
Feasibility of retainment between groups
Time frame: 18 Months
Feasibility of the trial between groups
Time frame: 18 Months
Feasibility of randomization between groups
Time frame: 18 Months
Feasibility of inclusion between groups
Time frame: 18 Months
Feasibility of therapeutic intervention between groups
Time frame: 18 Months
Study acceptability between groups
Time frame: 18 Months
Patient-reported reasons for abandoning the study between groups
Time frame: 18 Months
Decrease in alcohol consumption between groups
Time frame: Day 0
Decrease in alcohol consumption between groups
Time frame: Week 6 (or discharge if it takes place later)
Decrease in alcohol consumption between groups
Time frame: Week 12
Total alcohol consumption between groups
Time frame: Day 0
Total alcohol consumption between groups
Time frame: Week 6 (or discharge if it takes place later)
Total alcohol consumption between groups
Time frame: Week 12
Time before first drink
Time frame: Day 0
Time before first drink
Time frame: Week 6 (or discharge if it takes place later)
Time before first drink
Time frame: Week 12
Time to first day of heavy drinking
Time frame: Day 0
Time to first day of heavy drinking
Time frame: Week 6 (or discharge if it takes place later)
Time to first day of heavy drinking
Time frame: Week 12
Craving between groups
Time frame: Day 0
Craving between groups
Time frame: Week 12
Quality of life between groups
Time frame: Day 0
Quality of life between groups
Time frame: Week 12
Depression between groups
Time frame: Day 0
Depression between groups
Time frame: Week 12
Anxiety between groups
Time frame: Day 0
Anxiety between groups
Time frame: Week 12
Emotion regulation difficulties between groups
Time frame: Day 0
Emotion regulation difficulties between groups
Time frame: Week 12
Rejection sensitivity between groups
Time frame: Day 0
Rejection sensitivity between groups
Time frame: Week 12
Meaning in life between groups
Time frame: Day 0
Meaning in life between groups
Time frame: Week 3
Meaning in life between groups
Time frame: Week 6
Meaning in life between groups
Time frame: Week 12
Cognitive functioning between groups
Time frame: Day 0
Cognitive functioning between groups
Time frame: Second psilocybin session (Week 4)
Role of cognitive function at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Time frame: Day 0
Role of Posttraumatic Stress Disorder at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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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. This study is not recruiting at the moment.
Amandine Luquiens principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybin therapy, Inactive Psilocybin therapy and Electroencephalogram in people with Alcohol-Related Disorders and Depressive Disorder, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 6 inclusion and 25 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: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention between groups (time frame: After 2nd experimental session (Week 4)). 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 19 Mar 2025.