Clinical trial NCT05674929: An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
Official title: An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Beckley Psytech Limited
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief summary: An open-label, Phase 2a study to evaluate the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of BPL-003 combined with relapse prevention psychological support, to explore the potential effects on alcohol use and related symptoms in patients with Alcohol Use Disorder.

Detailed description: Approximately 12 eligible participants will be receive a single dose of BPL-003, given intranasally, with 12 weeks of follow-up assessments. Psychological support will be given before, during and after dosing

Eligibility criteria: Inclusion Criteria:

1. Willing and able to give informed consent.
2. Age 18 to 64 years at Screening.
3. Diagnosed with moderate to severe AUD.
4. Minimum of 4 heavy drinking days in the 28 days before Screening.
5. No more than 14 days have elapsed since the last HDD or completion of detoxification, with no HDD in the 72 hours prior to dosing and no alcohol at all in the 24 hours prior to dosing
6. Willing to abstain from using recreational drugs from Screening until end of the study
7. Willing to abstain from smoking during their time in the clinic on the day of dosing.
8. Willing to refrain from psychedelic drug use from Screening until the end of the study.
9. Living in stable/secure accommodation in the community.
10. In possession of a personal mobile phone and able to nominate at least one locator individual (eg, a family member, friend, or recovery mentor), with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments.

Exclusion Criteria:

1. Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder.
2. Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression.
3. A clinical diagnosis of post-traumatic stress disorder.
4. Suicide ideation or behaviour or self-injurious behaviours within the 12 months before screening
5. Regular use of or dependence on other drugs other than caffeine or nicotine.
6. Any self-reported use of psychedelic compounds in the past 6 months.
7. History of seizures.
8. Patients who are exhibiting any signs of alcohol withdrawal on dosing day.
9. Positive for alcohol on dosing day.
10. Positive urine drug screen for illicit drugs or drugs of abuse.
11. Any nasal obstruction, blockage, or symptoms of congestion.
12. Any personal or family history of malignant hyperthermia.
13. Patients with an uncontrolled cardiovascular disorder that, in the opinion of the Investigator, may interfere with the interpretation of study results or constitute a health risk for the patient if he/she takes part in the study.
14. Uncontrolled or insulin-dependent diabetes.

Primary outcomes:
measure: Percentage of patients with treatment emergent adverse events
timeFrame: Up to12 weeks
measure: Percentage of patients with clinically significant abnormal laboratory tests
timeFrame: Up to12 weeks
measure: Percentage of patients with clinically significant abnormal vital signs
timeFrame: Up to12 weeks
measure: Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS)
timeFrame: Up to12 weeks
Secondary outcomes:
measure: Effects on the Mystical Experience Questionnaire (MEQ30)
timeFrame: 1 Day
measure: Effects on the Ego Dissolution Inventory (EDI)
timeFrame: 1 Day
measure: Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30)
timeFrame: 1 Day
measure: Percentage of patients experiencing a an ego dissolution, as assessed by the Ego Dissolution Inventory (EDI)
timeFrame: 1 Day
measure: Description of the BPL-003 subjective experience data, from a qualitative interview
timeFrame: 1 Day
measure: Readiness for discharge questionnaire
timeFrame: 1 Day
measure: Feedback from therapists on the frequency and duration of psychotherapy sessions, therapy manual and overall therapy model
timeFrame: 1 Day
Other outcomes:
measure: Timeline Follow-Back (TLFB) interview to assess the number of days abstinent from alcohol
timeFrame: Up to 12 weeks
measure: Timeline Follow-Back (TLFB) interview to assess the longest duration of continuous alcohol abstinence
timeFrame: Up to 12 weeks
measure: Timeline Follow-Back (TLFB) interview to assess the number of days after BPL-003 dosing to first drink
timeFrame: Up to 12 weeks
measure: Timeline Follow-Back (TLFB) interview to assess the number of days after BPL-003 dosing to first heavy drink day (HDD)
timeFrame: Up to 12 weeks
Locations:
city: London
country: United Kingdom
facility: Clerkenwell Health
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: Beckley Psytech Ltd
name: VP & Head of Clinical Development, PhD
role: STUDY_DIRECTOR
References: