Severe Alcohol Use DisorderPhase 2NCT06160232
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder
A Phase 2 study testing Psilocybin (high dose) in people with Severe Alcohol Use Disorder, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Severe Alcohol Use Disorder
- What is being tested?
- Psilocybin (high dose)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2024to 15 Jun 2026
- Phase
- Phase 2
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients between 21 and 64 years old, with a BMI between 17.5 and 30 kg/m2 who
- Want to stop or decrease their drinking;
- Agree to have all psilocybin-assisted therapy sessions (preparation, administration, integration) and semi-structured interviews recorded;
- Have a diagnosis of Severe Alcohol Use Disorder (sAUD), according to the DSM-V (6 criteria or more), ascertained using the Mini International Neuropsychiatric Interview (M.I.N.I 7.0.2).
- Are not currently receiving any pharmacological treatment for sAUD and are willing to engage in all study requirements (including attending all study visits, preparatory sessions, integration sessions, follow-up sessions, and completing all study evaluations).
- Women of childbearing potential must have a negative serum pregnancy test at admission (day 1 +/-2) and a negative urine pregnancy test the day before psilocybin administration (day 19 +/-2).
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- Women of childbearing potential must be using an effective, established method of contraception from inclusion until four weeks post-hospital discharge (5 weeks post-psilocybin administration). The following methods of contraception, if used properly and used for the duration of the study, are considered reliable: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - oral, - intravaginal, - transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation: - oral, - injectable, - implantable; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner (provided that partner is the sole sexual partner of the woman of child-bearing potential trial participant and that the vasectomised partner has received medical assessment of the surgical success; sexual abstinence (only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject). Note: female participants who are permanently sterilized (eg hysterectomy and/or bilateral salpingectomy) or post-menopausal (at least 48 consecutive weeks without menstruation) are not considered as being of child bearing potential.
- Men with a woman of childbearing potential partner should use a condom from inclusion until four weeks post-hospital discharge (5 weeks post-psilocybin administration).
- Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
- Willing to refrain from consuming psychoactive substances after enrolling in the study and during follow-up.
- Ability to provide voluntary written informed consent after receiving written information about the study protocol.
- Undergoing a 4-week alcohol detoxification program at the Brugmann University Hospital.
- Remaining abstinent from alcohol during the detoxification program (abstinence will be monitored using a breathalyzer during unannounced checks).
- Normal level of language comprehension (French).
- Affiliation to the Belgian social security system.
Who cannot join
- Allergy, hypersensitivity, or other adverse reactions to previous use of psilocybin or other hallucinogens.
- Uncorrected hypertension.
- Cardiovascular diseases, hepatic diseases, gastroenterological diseases, hematologic diseases, renal diseases, endocrine diseases, metabolic diseases, inflammatory diseases, neurological diseases or any other somatic condition that, in the opinion of the medical investigator (necessarily an M.D.), would pose a risk to the participant's participation in the study.
- Other somatic conditions that, in the opinion of the investigator, would pose a risk to the participant's participation in the study.
- Decompensated hepatic cirrhosis, defined by Child B or C score.
- Serious abnormalities of complete blood count or chemistries, biological abnormalities including TP < 50%, albumin < 35 g/L, total bilirubin > 35 μmol/L, leading to a Child B or C score.
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- Abnormal ECG. Clinical ECG diagnoses and ECG signs subject to exclusion and needing medical attention: Atrial flutter or fibrillation, AV block 2nd degree or higher, AVNRT (AV-nodal re-entry tachycardia), AVRT (atrioventricular re-entry tachycardia), tri-fascicular block, signs of rare conditions such as Brugada syndrome or Wolff-Parkinson White Syndrome (Delta wave), Epsilon wave, Fusion beats, signs of acute myocardial ischemia such as ST elevation, signs of pulmonary embolism, Long QTc (≥470 ms for males and ≥480 ms for females), Sinus bradycardia <40bpm, Sinus node dysfunction (Sick sinus syndrome), Sinus node exit block, Supraventricular tachycardia (SVT), Torsades de Pointes, Ventricular fibrillation, Ventricular flutter, Ventricular tachycardia. This list might not be exhaustive and any other anomaly will be thoroughly assessed by the study physician, lead to exclusion if deemed necessary and referred to cardiology if warranted.
- Cognitive impairment (Folstein Mini Mental State Exam (Folstein et al., 1975) score < 26).
- Alcohol withdrawal complication(s), seizure, head injury or stroke within the last 6 months.
- Current active acute stress disorder/post-traumatic stress disorder,
- Lifetime history of schizophrenia spectrum disorders (schizophrenia, schizoaffective disorder, unspecified), other psychotic disorders or bipolar spectrum disorders (Type I, II, unspecified).
- Lifetime history of major depressive episode with psychotic features.
- Significant risk of suicide according to clinician assessment.
- Family history of schizophrenia spectrum disorders (schizophrenia, schizoaffective disorder, unspecified), or other psychotic disorders, or bipolar Type I in first- or second-degree relatives.
- Other substance use disorder (except for caffeine, nicotine, or cannabis) according to DSM-V criteria in the two months preceding inclusion to the study.
- Severe cannabis use disorder according to the DSM-V.
- Need to take medication with significant potential to interact with classical psychedelics (e.g., antidepressants except selective serotonin reuptake inhibitors (SSRIs), antipsychotics, psychostimulants, treatments for alcohol addiction as naltrexone or acamprosate or baclofen, opioid agonist treatment as buprenorphine or methadone, lithium, anticonvulsants, other dopaminergic or serotonergic agents, inhibitors of UGT1A9 and 1A10, monoamine oxidase inhibitors (MAOIs), aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs)).
- High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
- History of hallucinogen use disorder, or >25 lifetime uses.
- Pregnancy and breastfeeding, at screening visit and till dosing day.
- Known or suspected non-compliance.
- Previous enrollment into the current study.
- Enrollment of the investigator, his/her family members, employees and other dependent persons.
- Patient subject to a legal protection measure (guardianship, curatorship or safeguard of justice), patient unable to express consent and not subject to a protection measure.
- Patients with language barrier (unable to follow the protocol or respond to clinical assessments).
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Brugmann University Hospital
Brussels
Laetitia Vanderijst, M.Sc.
About this study
Official title: Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
Read the detailed description
A substantial proportion of patients with alcohol use disorder does not respond to available treatments, which calls for the development of new alternatives. In parallel, psilocybin-assisted therapy for alcohol use disorder has recently yielded promising preliminary results. Building on extant findings, the proposed study aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder, and to characterize associated changes in the two key neurocognitive systems identified by dual-process models of addiction.
In this double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial, 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy within the context of a 4-week inpatient rehabilitation for severe alcohol use disorder. The experimental group will receive a high dose of psilocybin (30 mg), whereas the control group will receive an active placebo dose of psilocybin, both within the context of a brief standardized psychotherapeutic intervention. The primary clinical outcome is the between-group difference in terms of the change in percentage of heavy drinking days from baseline to four weeks post-hospital discharge, whilst safety and feasibility metrics will also be reported as primary outcomes. Key secondary assessments include between-group differences in terms of changes in 1) drinking behavior parameters up to six months post-hospital discharge, 2) phosphatidyl-ethanol blood concentration, an objective biomarker of alcohol consumption, 3) symptoms of depression, anxiety, trauma, and global functioning, 4) neuroplasticity and key neurocognitive mechanisms associated with addiction, 5) psychological processes and alcohol-related parameters.
- Conditions
- Severe Alcohol Use Disorder
- Being tested
- Psilocybin (high dose), Active placebo (low dose of psilocybin)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (high dose)Drug
Psilocybin-assisted therapy
Active placebo (low dose of psilocybin)Drug
Placebo-assisted therapy
| Study group | Role | What they receive |
|---|---|---|
| high dose psilocybin | Experimental | 31 participants will receive a single administration of 30mg psilocybin provided within the context of a brief standardized psychotherapeutic intervention. Receives: Drug: Psilocybin (high dose) |
| low dose psilocybin (active placebo) | Placebo comparator | 31 participants will receive a single administration of a very low dose of psilocybin (active placebo) provided within the context of a brief standardized psychotherapeutic intervention. Receives: Drug: Active placebo (low dose of psilocybin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary clinical outcome: change in percentage of heavy drinking days
The primary clinical outcome is the difference between the two treatment arms in terms of change from baseline (going back 8 weeks pre-enrolment) to 4 weeks post-hospital discharge (week 1 to 4 post-discharge) in the percentage of heavy drinking days. A heavy drinking day is defined as a day with ≥ 5 standard drinks/60g of alcohol for males, and ≥ 4 standard drinks/48g of alcohol for females. Alcohol consumption will be measured using the Timeline Follow-Back method (Sobell \& Sobell, 1992), a semi-structured interview that provides estimates of the daily quantity, frequency, and pattern of alcohol (and other drugs) use during a set time period. The method has demonstrated adequate to excellent reliability and validity over a wide range of studies and clinical contexts (Carey, 1997; Sobell et al., 1996).
Measured: Baseline (going back to 8 weeks pre-enrolment) to 4 weeks post-hospital discharge
Feasibility: recruitment and retention rate
Recruitment and retention rate will be recorded and reported. A consort diagram displaying participant retention at each phase of the recruitment, screening and data collection process will be presented. We will report the numbers of individuals provided with participant information sheets who subsequently decided not to participate in the trial, number that underwent screening and number of drop-outs. For full transparency on inclusivity, information on the demographics and reason for exclusion will be reported from the screening dataset.
Measured: Recruitment rate: at screening and enrolment. Retention rate: at each study visit
Safety: adverse events
Adverse events will be systematically assessed at each study visit and follow-ups. Adverse events summary tables will display the total number of participants reporting an adverse event and the percentage of participants (%) with an adverse event.
Measured: At each study visit
Secondary outcomes (16)
Percent Heavy Drinking Days
Alcohol consumption as measured with the Timeline Follow Back Method
Measured: from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 6 months post-hospital discharge (week 5 to 26 weeks)
Drinks per Day
Alcohol consumption as measured with the Timeline Follow Back Method
Measured: from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 4 weeks and 6 months post-hospital discharge
Percent Days Abstinent
Alcohol consumption as measured with the Timeline Follow Back Method
Measured: from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 4 weeks and 6 months post-hospital discharge
EEG-derived auditory long-term potentiation
Index of cortical neuroplasticity
Measured: Neuroplasticity EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)
EEG-derived alcohol cue reactivity
Measured: EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)
EEG-derived inhibitory control
Measured: EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)
Psychological flexibility
The Acceptance and Action Questionnaire II (AAQII; Bond et al., 2011)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Connectedness
The Watts Connectedness Scale (WCS; Watts et al., 2022)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Interoception
The Multidimensional Assessment of Interoceptive Awareness (MAIA; Mehling et al., 2012)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Depressive symptoms
Beck Depression Inventory (BDI; Beck et al., 1961)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Anxiety symptoms
StateTrait Anxiety Inventory - trait subscale (STAI; Spielberger et al., 1983)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Trauma symptoms
International Trauma Questionnaire (ITQ; Cloitre et al., 2018)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Substance use recovery (patient reported outcome measure - PROM)
Substance Use Recovery Evaluator (SURE; Neale et al., 2016)
Measured: Baseline as well as four weeks, three and six months post-hospital discharge.
Alcohol craving
Penn Alcohol Craving Scale (PACS; Flannery et al., 1999)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Abstinence self-efficacy
Alcohol Abstinence Self-Efficacy Scale (AASE; DiClemente et al., 1994)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Readiness to change
Likert-scale ratings of the participant's perception of 1) the importance of change in drinking; 2) confidence of ability to change; 3) readiness for change; 4) Commitment to the goal of abstinence (Bogenschutz et al., 2022)
Measured: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start15 Feb 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Alcohol Use DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, randomized, double-blind, placebo-controlled, 1:1 parallel-group 7-month clinical trial comparing the effects of a high dose of psilocybin to those of a low dose of psilocybin (active placebo) provided within the context of a brief standardized psychotherapeutic intervention in 62 participants with severe alcohol use disorder.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Charles Kornreich, Brugmann University Hospital
- Investigators
- Charles Kornreich, M.D. Ph.D., Principal investigator, Brugmann University Hospital, Free University of Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160232
- Sponsor's protocol ID
- CHUB-Psy-PATh for sAUD
- Other IDs
- 2022-002369-14
- Status last verified
- Aug 2024
- First submitted
- 29 Nov 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bogenschutz MP, Ross S, Bhatt S, Baron T, Forcehimes AA, Laska E, Mennenga SE, O'Donnell K, Owens LT, Podrebarac S, Rotrosen J, Tonigan JS, Worth L. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Oct 1;79(10):953-962. doi: 10.1001/jamapsychiatry.2022.2096.
PubMed 36001306Vanderijst L, Hever F, Buot A, Daure C, Benoit J, Hanak C, Veeser J, Morgieve M, Campanella S, Kornreich C, Mallet L, Leys C, Noel X. Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial. BMC Psychiatry. 2024 Jan 26;24(1):77. doi: 10.1186/s12888-024-05502-y.
PubMed 38279085
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Feasibility, Clinical Efficacy & (Neuro)Cognitive Mechanisms
- ClinicalTrials.gov ID
- NCT06160232
- Acronym / sponsor ID
- CHUB-Psy-PATh for sAUD
- Conditions
- Severe Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 7 Dec 2023 (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.
Psilocybin-Assisted Therapy for Severe Alcohol Use Disorder: Protocol for a Double-Blind, Randomized, Placebo-Controlled, 7-month Parallel-Group Phase II Superiority Trial
Detailed description
A substantial proportion of patients with alcohol use disorder does not respond to available treatments, which calls for the development of new alternatives. In parallel, psilocybin-assisted therapy for alcohol use disorder has recently yielded promising preliminary results. Building on extant findings, the proposed study aims to determine the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy as a complementary intervention during inpatient rehabilitation for severe alcohol use disorder, and to characterize associated changes in the two key neurocognitive systems identified by dual-process models of addiction.
In this double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial, 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy within the context of a 4-week inpatient rehabilitation for severe alcohol use disorder. The experimental group will receive a high dose of psilocybin (30 mg), whereas the control group will receive an active placebo dose of psilocybin, both within the context of a brief standardized psychotherapeutic intervention. The primary clinical outcome is the between-group difference in terms of the change in percentage of heavy drinking days from baseline to four weeks post-hospital discharge, whilst safety and feasibility metrics will also be reported as primary outcomes. Key secondary assessments include between-group differences in terms of changes in 1) drinking behavior parameters up to six months post-hospital discharge, 2) phosphatidyl-ethanol blood concentration, an objective biomarker of alcohol consumption, 3) symptoms of depression, anxiety, trauma, and global functioning, 4) neuroplasticity and key neurocognitive mechanisms associated with addiction, 5) psychological processes and alcohol-related parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Monocentric, randomized, double-blind, placebo-controlled, 1:1 parallel-group 7-month clinical trial comparing the effects of a high dose of psilocybin to those of a low dose of psilocybin (active placebo) provided within the context of a brief standardized psychotherapeutic intervention in 62 participants with severe alcohol use disorder.
| Arm | Type | Receives |
|---|---|---|
| high dose psilocybin | Experimental | Drug: Psilocybin (high dose)31 participants will receive a single administration of 30mg psilocybin provided within the context of a brief standardized psychotherapeutic intervention. |
| low dose psilocybin (active placebo) | Placebo comparator | Drug: Active placebo (low dose of psilocybin)31 participants will receive a single administration of a very low dose of psilocybin (active placebo) provided within the context of a brief standardized psychotherapeutic intervention. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male or female patients between 21 and 64 years old, with a BMI between 17.5 and 30 kg/m2 who
- Want to stop or decrease their drinking;
- Agree to have all psilocybin-assisted therapy sessions (preparation, administration, integration) and semi-structured interviews recorded;
- Have a diagnosis of Severe Alcohol Use Disorder (sAUD), according to the DSM-V (6 criteria or more), ascertained using the Mini International Neuropsychiatric Interview (M.I.N.I 7.0.2).
- Are not currently receiving any pharmacological treatment for sAUD and are willing to engage in all study requirements (including attending all study visits, preparatory sessions, integration sessions, follow-up sessions, and completing all study evaluations).
Key exclusion criteria (25 listed)
- Allergy, hypersensitivity, or other adverse reactions to previous use of psilocybin or other hallucinogens.
- Uncorrected hypertension.
- Cardiovascular diseases, hepatic diseases, gastroenterological diseases, hematologic diseases, renal diseases, endocrine diseases, metabolic diseases, inflammatory diseases, neurological diseases or any other somatic condition that, in the opinion of the medical investigator (necessarily an M.D.), would pose a risk to the participant's participation in the study.
- Other somatic conditions that, in the opinion of the investigator, would pose a risk to the participant's participation in the study.
- Decompensated hepatic cirrhosis, defined by Child B or C score.
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 (high dose)Psilocybin-assisted therapy | Drug | high dose psilocybin |
| Active placebo (low dose of psilocybin)Placebo-assisted therapy | Drug | low dose psilocybin (active placebo) |
Primary outcome
Primary clinical outcome: change in percentage of heavy drinking days
Time frame: Baseline (going back to 8 weeks pre-enrolment) to 4 weeks post-hospital discharge
The primary clinical outcome is the difference between the two treatment arms in terms of change from baseline (going back 8 weeks pre-enrolment) to 4 weeks post-hospital discharge (week 1 to 4 post-discharge) in the percentage of heavy drinking days. A heavy drinking day is defined as a day with ≥ 5 standard drinks/60g of alcohol for males, and ≥ 4 standard drinks/48g of alcohol for females. Alcohol consumption will be measured using the Timeline Follow-Back method (Sobell \& Sobell, 1992), a semi-structured interview that provides estimates of the daily quantity, frequency, and pattern of alcohol (and other drugs) use during a set time period. The method has demonstrated adequate to excellent reliability and validity over a wide range of studies and clinical contexts (Carey, 1997; Sobell et al., 1996).
Feasibility: recruitment and retention rate
Time frame: Recruitment rate: at screening and enrolment. Retention rate: at each study visit
Recruitment and retention rate will be recorded and reported. A consort diagram displaying participant retention at each phase of the recruitment, screening and data collection process will be presented. We will report the numbers of individuals provided with participant information sheets who subsequently decided not to participate in the trial, number that underwent screening and number of drop-outs. For full transparency on inclusivity, information on the demographics and reason for exclusion will be reported from the screening dataset.
Safety: adverse events
Time frame: At each study visit
Adverse events will be systematically assessed at each study visit and follow-ups. Adverse events summary tables will display the total number of participants reporting an adverse event and the percentage of participants (%) with an adverse event.
16 secondary outcomes
Percent Heavy Drinking Days
Time frame: from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 6 months post-hospital discharge (week 5 to 26 weeks)
Drinks per Day
Time frame: from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 4 weeks and 6 months post-hospital discharge
Percent Days Abstinent
Time frame: from pre-hospitalisation (up to 8 weeks pre-hospitalization) to 4 weeks and 6 months post-hospital discharge
EEG-derived auditory long-term potentiation
Time frame: Neuroplasticity EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)
EEG-derived alcohol cue reactivity
Time frame: EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)
EEG-derived inhibitory control
Time frame: EEG data will be collected pre-dosing and twice post-dosing (+1 day, +7 days)
Psychological flexibility
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Connectedness
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Interoception
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Depressive symptoms
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Anxiety symptoms
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Trauma symptoms
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Substance use recovery (patient reported outcome measure - PROM)
Time frame: Baseline as well as four weeks, three and six months post-hospital discharge.
Alcohol craving
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Abstinence self-efficacy
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Readiness to change
Time frame: Baseline, one day prior to psilocybin administration, one week post-psilocybin administration, as well as four weeks, three and six months post-hospital discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 36001306Bogenschutz MP, Ross S, Bhatt S, Baron T, Forcehimes AA, Laska E, Mennenga SE, O'Donnell K, Owens LT, Podrebarac S, Rotrosen J, Tonigan JS, Worth L. Percentage of Heavy Drinking Days Following Psilocybin-Assisted Psychotherapy vs Placebo in the Treatment of Adult Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Oct 1;79(10):953-962. doi: 10.1001/jamapsychiatry.2022.2096.
- Derived from this study: PubMed 38279085Vanderijst L, Hever F, Buot A, Daure C, Benoit J, Hanak C, Veeser J, Morgieve M, Campanella S, Kornreich C, Mallet L, Leys C, Noel X. Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial. BMC Psychiatry. 2024 Jan 26;24(1):77. doi: 10.1186/s12888-024-05502-y.
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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.
Charles Kornreich, M.D. Ph.D. principal investigator
Brugmann University Hospital, Free University of Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin (high dose) in people with Severe Alcohol Use Disorder, run by Brugmann University Hospital at 1 site in Belgium.
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 15 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: status not confirmed, as of the sponsor's last update on 7 Aug 2024. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laetitia Vanderijst, M.Sc. (02 477 22 33, laetitia.vanderijst@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary clinical outcome: change in percentage of heavy drinking days (time frame: Baseline (going back to 8 weeks pre-enrolment) to 4 weeks post-hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06160232, which also lists 2 linked publications.
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 7 Aug 2024.