- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06235411
Psilocybin in Alcohol Use Disorder With Comorbid Depression (PAD)
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amandine Luquiens
- Phone Number: 04.66.68.69.98
- Email: amandine.luquiens@chu-nimes.fr
Study Locations
-
-
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Nîmes, France, 30029
- CHU
-
Sub-Investigator:
- Anouk Lequien
-
Principal Investigator:
- Amandine Luquiens
-
Contact:
- Anissa Megzari
- Phone Number: 0466686998
- Email: drc@chu-nimes.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
|
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).
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Placebo Comparator: Control group
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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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of the intervention between groups
Time Frame: After 2nd experimental session (Week 4)
|
Number of patients who completed both sessions
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After 2nd experimental session (Week 4)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment between groups
Time Frame: 18 Months
|
Number of patients screened per month/number of patients included per month.
|
18 Months
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Feasibility of retainment between groups
Time Frame: 18 Months
|
Average time (days) between screening and inclusion.
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18 Months
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Feasibility of the trial between groups
Time Frame: 18 Months
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Rate (%) of eligible patients who are included in the study.
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18 Months
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Feasibility of randomization between groups
Time Frame: 18 Months
|
Rate (%) of patients included who had at least one treatment administration session
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18 Months
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Feasibility of inclusion between groups
Time Frame: 18 Months
|
Rate (%) of assessment sessions that were completed.
|
18 Months
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Feasibility of therapeutic intervention between groups
Time Frame: 18 Months
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Duration of assessment sessions (minutes).
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18 Months
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Study acceptability between groups
Time Frame: 18 Months
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Number of patients leaving the study prematurely for any reason.
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18 Months
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Patient-reported reasons for abandoning the study between groups
Time Frame: 18 Months
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Qualitative description of reasons cited by patients
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18 Months
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Decrease in alcohol consumption between groups
Time Frame: Day 0
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Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
|
Day 0
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Decrease in alcohol consumption between groups
Time Frame: Week 6 (or discharge if it takes place later)
|
Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
|
Week 6 (or discharge if it takes place later)
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Decrease in alcohol consumption between groups
Time Frame: Week 12
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Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
|
Week 12
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Total alcohol consumption between groups
Time Frame: Day 0
|
Total alcohol consumption during previous 4 weeks
|
Day 0
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Total alcohol consumption between groups
Time Frame: Week 6 (or discharge if it takes place later)
|
Total alcohol consumption during previous 4 weeks
|
Week 6 (or discharge if it takes place later)
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Total alcohol consumption between groups
Time Frame: Week 12
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Total alcohol consumption during previous 4 weeks
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Week 12
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Time before first drink
Time Frame: Day 0
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Days
|
Day 0
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Time before first drink
Time Frame: Week 6 (or discharge if it takes place later)
|
Days
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Week 6 (or discharge if it takes place later)
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Time before first drink
Time Frame: Week 12
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Days
|
Week 12
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Time to first day of heavy drinking
Time Frame: Day 0
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Days
|
Day 0
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Time to first day of heavy drinking
Time Frame: Week 6 (or discharge if it takes place later)
|
Days
|
Week 6 (or discharge if it takes place later)
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Time to first day of heavy drinking
Time Frame: Week 12
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Days
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Week 12
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Craving between groups
Time Frame: Day 0
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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.
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Day 0
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Craving between groups
Time Frame: Week 12
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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.
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Week 12
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Quality of life between groups
Time Frame: Day 0
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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.
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Day 0
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Quality of life between groups
Time Frame: Week 12
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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.
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Week 12
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Depression between groups
Time Frame: Day 0
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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.
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Day 0
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Depression between groups
Time Frame: Week 12
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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.
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Week 12
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Anxiety between groups
Time Frame: Day 0
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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.
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Day 0
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Anxiety between groups
Time Frame: Week 12
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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.
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Week 12
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Emotion regulation difficulties between groups
Time Frame: Day 0
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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.
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Day 0
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Emotion regulation difficulties between groups
Time Frame: Week 12
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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.
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Week 12
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Rejection sensitivity between groups
Time Frame: Day 0
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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.
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Day 0
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Rejection sensitivity between groups
Time Frame: Week 12
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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.
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Week 12
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Meaning in life between groups
Time Frame: Day 0
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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
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Day 0
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Meaning in life between groups
Time Frame: Week 3
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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
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Week 3
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Meaning in life between groups
Time Frame: Week 6
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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
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Week 6
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Meaning in life between groups
Time Frame: Week 12
|
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
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Week 12
|
Cognitive functioning between groups
Time Frame: Day 0
|
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).
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Day 0
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Cognitive functioning between groups
Time Frame: Second psilocybin session (Week 4)
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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).
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Second psilocybin session (Week 4)
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Role of cognitive function at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Time Frame: Day 0
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Montreal Cognitive Assessment (MoCA); measuring attention, concentration, executive functions, memory, language, visuoconstructive abilities, abstraction abilities, calculation and orientation.
Score 0-30.
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Day 0
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Role of Posttraumatic Stress Disorder at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Time Frame: Day 0
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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.
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Day 0
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Role of attachment at baseline on change in the percentage of heavy drinking days in preceding 4 weeks
Time Frame: Day 0
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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.
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Day 0
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Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitors
Time Frame: Day 0
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Concomitant Selective serotonin reuptake inhibitors yes/no
|
Day 0
|
Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitors
Time Frame: Week 3
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Concomitant Selective serotonin reuptake inhibitors yes/no
|
Week 3
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Change in the percentage of heavy drinking days in preceding 4 weeks according to concomitant Selective serotonin reuptake inhibitors
Time Frame: Week 6
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Concomitant Selective serotonin reuptake inhibitors yes/no
|
Week 6
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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
Time Frame: Week 12
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Concomitant Selective serotonin reuptake inhibitors yes/no
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Week 12
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Role of the patient-reported quality of the hallucinogenic experience on change in the percentage of heavy drinking days in preceding 4 weeks
Time Frame: End of 1st psilocybin session (Week 1)
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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".
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End of 1st psilocybin session (Week 1)
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Role of the patient-reported quality of the hallucinogenic experience on change in the percentage of heavy drinking days in preceding 4 weeks
Time Frame: End of 2nd psilocybin session (Week 4)
|
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".
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End of 2nd psilocybin session (Week 4)
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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
Time Frame: Before 1st experimental session (Week 1)
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Electroencephalogram parameters: alpha coherence in the resting state
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Before 1st experimental session (Week 1)
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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
Time Frame: During the 1st experimental session (Week 1)
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Electroencephalogram parameters: alpha coherence in the resting state
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During the 1st experimental session (Week 1)
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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
Time Frame: Day after 2nd experimental session (Week 4)
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Electroencephalogram parameters: alpha coherence in the resting state
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Day after 2nd experimental session (Week 4)
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Change in the percentage of heavy drinking days in preceding 4 weeks according to the quality of the hallucinogenic experience
Time Frame: Day after 1st experimental session (Week 1)
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Hallucinogenic experience assessed through qualitative analysis of audio-recorded verbatim of the integration session.
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Day after 1st experimental session (Week 1)
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Change in the percentage of heavy drinking days in preceding 4 weeks according to the quality of the hallucinogenic experience
Time Frame: Day after 2nd experimental session (Week 4)
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Hallucinogenic experience assessed through qualitative analysis of audio-recorded verbatim of the integration session.
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Day after 2nd experimental session (Week 4)
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Collaborators and Investigators
Investigators
- Principal Investigator: Amandine Luquiens, CHU de Nimes
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRESP/2022/AL-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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