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a control condition (1 mg psilocybin), in addition to the usual treatment, will be acceptable and feasible in recently withdrawn individuals suffering from AUD and depressive symptoms, between 14 and 60 days after their last alcohol consumption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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
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).
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).
* Rest EEG prior to first treatment administration * EEG during first treatment administration * Rest EEG during integration session after second treatment administration
Three 7ml EDTA tubes will be taken in the morning on an empty stomach at day 0 and at 3 weeks.
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 cerebral at day 0 and 3 weeks
CHU
Nîmes, Nîmes, France
Feasibility of the intervention between groups
Number of patients who completed both sessions
Time frame: After 2nd experimental session (Week 4)
Feasibility of recruitment between groups
Number of patients screened per month/number of patients included per month.
Time frame: 18 Months
Feasibility of retainment between groups
Average time (days) between screening and inclusion.
Time frame: 18 Months
Feasibility of the trial between groups
Rate (%) of eligible patients who are included in the study.
Time frame: 18 Months
Feasibility of randomization between groups
Rate (%) of patients included who had at least one treatment administration session
Time frame: 18 Months
Feasibility of inclusion between groups
Rate (%) of assessment sessions that were completed.
Time frame: 18 Months
Feasibility of therapeutic intervention between groups
Duration of assessment sessions (minutes).
Time frame: 18 Months
Study acceptability between groups
Number of patients leaving the study prematurely for any reason.
Time frame: 18 Months
Patient-reported reasons for abandoning the study between groups
Qualitative description of reasons cited by patients
Time frame: 18 Months
Decrease in alcohol consumption between groups
Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
Time frame: Day 0
Decrease in alcohol consumption between groups
Decrease in the percentage of days of heavy drinking days during previous 4 weeks versus baseline
Time frame: 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
Time frame: Week 12
Total alcohol consumption between groups
Total alcohol consumption during previous 4 weeks
Time frame: Day 0
Total alcohol consumption between groups
Total alcohol consumption during previous 4 weeks
Time frame: Week 6 (or discharge if it takes place later)
Total alcohol consumption between groups
Total alcohol consumption during previous 4 weeks
Time frame: Week 12
Time before first drink
Days
Time frame: Day 0
Time before first drink
Days
Time frame: Week 6 (or discharge if it takes place later)
Time before first drink
Days
Time frame: Week 12
Time to first day of heavy drinking
Days
Time frame: Day 0
Time to first day of heavy drinking
Days
Time frame: Week 6 (or discharge if it takes place later)
Time to first day of heavy drinking
Days
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
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
Montreal Cognitive Assessment (MoCA); measuring attention, concentration, executive functions, memory, language, visuoconstructive abilities, abstraction abilities, calculation and orientation. Score 0-30.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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".
Time frame: 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".
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 3
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