Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients
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|ClinicalTrials.gov Identifier: NCT04141501|
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Drug: Psilocybin Drug: Placebo oral capsule||Phase 2|
Two billion people globally consume alcohol, leading in 2016 to 2.8 million deaths (5.2% of all deaths) and 99.2 million Disability Adjusted Life Years (DALYs) lost (4.2% of all DALYs). Of all the diseases, conditions, and injuries attributable to alcohol use, alcohol use disorders (AUDs) create the largest health burden globally. However, approved pharmacological treatments for alcoholism are limited in their effectiveness. A recent proof of- concept study testing psilocybin in ten alcohol dependent patients provides encouraging efficacy results and safety data. The investigators, therefore, propose to test the efficacy of psilocybin for treating alcohol use disorder and study its underlying neurobiological mechanisms in a randomized, placebo controlled, double blind study. To evaluate effects of psilocybin on alcohol use behaviour, clinical symptoms, neurocognitive and emotional measures in patients with alcohol use disorder.
The present clinical trial aims at investigation the clinical and mechanistic effects of Psilocybin in Alcohol Addicted Patients.
Patients with alcohol use disorder who have undergone withdrawal treatment within the last 6 weeks will be investigated in a single-centre, double-blind, placebo-controlled, parallel-group design clinical trial contrasting the acute and persisting effects of psilocybin to those of placebo. Patients will be randomly assigned to psilocybin or placebo group with a 1:1 allocation ratio. The study comprises a total of 6 visits during 6 weeks and two follow-up online surveys (3 and 6 months after treatment). In addition, two follow-up surveys that can be completed from home will guarantee monitoring of long-lasting changes in symptomology and ensure all potential side-effects can be captured. On the treatment visit, a single dose of psilocybin (25mg) or placebo will be administered. Patients will be monitored until all effects have worn off.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase II, randomized, double blind, placebo controlled, parallel group, single center study|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder|
|Estimated Study Start Date :||May 25, 2020|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Placebo Comparator: Control: Placebo
30 Patients will receive placebo
Drug: Placebo oral capsule
single dose of mannitol (100%)
Active Comparator: Intervention: Psilocybin
30 Patients will receive psilocybin
single dose of psilocybin (25mg). orally in form of a capsule
- Changes in Time-Line Follow-Back [ Time Frame: every day from baseline until 6 months after the intervention ]measures changes of the alcohol use behavior over time.The Time-Line Follow-Back questionnaire assesses the standard glasses of alcohol consumed in a day. The minimum is no alcohol consumption, with the maximum being an open end. Less alcohol consumption will be the better outcome, whereas more alcohol consumption will be a worse outcome. The Time-Line Follow-Back isn't a scale.
- Brain [ Time Frame: five day before intervention until two weeks after intervention ]changes in functional connectivity during resting-state, changes in cue-reactivity, and autobiographic memory assessed with fMRI
- Empathy [ Time Frame: five day before intervention until two weeks after intervention ]Changes in empathy assessed with the Multifaceted Empathy Task
- Blood sample: Neural profile analysis [ Time Frame: five days before intervention ]To investigate the in vitro neuronal profile of psilocybin in alcohol dependent individuals blood cells before and after psilocybin administration will be differentiated into cortical neurons.
- Blood sample: Epigenetic analysis [ Time Frame: five day before intervention and two weeks after the intervention ]Genome-wide genetic analyses will be conducted to investigate association between gene variants and treatment outcomes. Genome-wide changes in epigenetic markers of treatment response will be analysed before and after psilocybin administration
- Blood sample: Markers of alcohol use [ Time Frame: will be analysed at screening visit and two weeks after the intervention ]Ethylglucuronid, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) will be analysed from blood samples (except for Ethylglucuronid which will be analysed in urine samples) as objective markers of alcohol use. Additionally, cortisol will be analysed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141501
|Contact: Nathalie Rieser||+41 44 384 33 firstname.lastname@example.org|
|Contact: Katrin Preller, PhD||+41 44 384 25 email@example.com|
|Principal Investigator:||Katrin Preller, Dr.||Psychiatric University Clinic|