Phase
Condition
Alcohol Use Disorder
Substance Abuse
Alcohol Dependence
Treatment
BPL-003
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Willing and able to give informed consent.
Age 18 to 64 years at Screening.
Diagnosed with moderate to severe AUD.
Minimum of 4 heavy drinking days in the 28 days before Screening.
No more than 14 days have elapsed since the last HDD or completion ofdetoxification, with no HDD in the 72 hours prior to dosing and no alcohol at all inthe 24 hours prior to dosing
Willing to abstain from using recreational drugs from Screening until end of thestudy
Willing to abstain from smoking during their time in the clinic on the day ofdosing.
Willing to refrain from psychedelic drug use from Screening until the end of thestudy.
Living in stable/secure accommodation in the community.
In possession of a personal mobile phone and able to nominate at least one locatorindividual (eg, a family member, friend, or recovery mentor), with a verifiableaddress and a telephone number to assist with the arrangement of follow-upappointments.
Exclusion
Exclusion Criteria:
Personal or first-degree family history of schizophrenia, bipolar disorder,psychotic disorder, delusional disorder, paranoid disorder or schizoaffectivedisorder.
Any major psychiatric disorders, with the exception of mild or moderate anxietyand/or depression.
A clinical diagnosis of post-traumatic stress disorder.
Suicide ideation or behaviour or self-injurious behaviours within the 12 monthsbefore screening
Regular use of or dependence on other drugs other than caffeine or nicotine.
Any self-reported use of psychedelic compounds in the past 6 months.
History of seizures.
Patients who are exhibiting any signs of alcohol withdrawal on dosing day.
Positive for alcohol on dosing day.
Positive urine drug screen for illicit drugs or drugs of abuse.
Any nasal obstruction, blockage, or symptoms of congestion.
Any personal or family history of malignant hyperthermia.
Patients with an uncontrolled cardiovascular disorder that, in the opinion of theInvestigator, may interfere with the interpretation of study results or constitute ahealth risk for the patient if he/she takes part in the study.
Uncontrolled or insulin-dependent diabetes.
Study Design
Study Description
Connect with a study center
Clerkenwell Health
London, W1G 8DR
United KingdomSite Not Available
King's College London
London,
United KingdomSite Not Available
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