An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674929
• Other study ID #: BPL-003-203
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Beckley Psytech Limited
• Contact: Beckley Psytech Ltd
• Phone: +44 (0)1865 987633
• Email: Medinfo[@]beckleypsytech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• BPL-003
A single dose administered intranasally

Locations

Country	Name	City	State
United Kingdom	Clerkenwell Health	London
United Kingdom	King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Beckley Psytech Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timeline Follow-Back (TLFB) interview to assess the number of days abstinent from alcohol		Up to 12 weeks
Other	Timeline Follow-Back (TLFB) interview to assess the longest duration of continuous alcohol abstinence		Up to 12 weeks
Other	Timeline Follow-Back (TLFB) interview to assess the number of days after BPL-003 dosing to first drink		Up to 12 weeks
Other	Timeline Follow-Back (TLFB) interview to assess the number of days after BPL-003 dosing to first heavy drink day (HDD)		Up to 12 weeks
Primary	Percentage of patients with treatment emergent adverse events		Up to12 weeks
Primary	Percentage of patients with clinically significant abnormal laboratory tests		Up to12 weeks
Primary	Percentage of patients with clinically significant abnormal vital signs		Up to12 weeks
Primary	Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS)		Up to12 weeks
Secondary	Effects on the Mystical Experience Questionnaire (MEQ30)		1 Day
Secondary	Effects on the Ego Dissolution Inventory (EDI)		1 Day
Secondary	Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30)		1 Day
Secondary	Percentage of patients experiencing a an ego dissolution, as assessed by the Ego Dissolution Inventory (EDI)		1 Day
Secondary	Description of the BPL-003 subjective experience data, from a qualitative interview		1 Day
Secondary	Readiness for discharge questionnaire		1 Day
Secondary	Feedback from therapists on the frequency and duration of psychotherapy sessions, therapy manual and overall therapy model		1 Day