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

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
BPL-003
Sponsored by
Beckley Psytech Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Willing and able to give informed consent. Age 18 to 64 years at Screening. Diagnosed with AUD of severity that may benefit from pharmacologic treatment, ie, moderate to severe AUD. Minimum of 10 heavy drinking days in the 28 days before Screening. No more than 14 days have elapsed since the last HDD or completion of detoxification. Can abstain from the consumption of any alcoholic substances for 72 hours prior to dosing. Willing to abstain from using recreational drugs from Screening until end of the study Willing to abstain from smoking during their time in the clinic on the day of dosing. Willing to refrain from psychedelic drug use from Screening until the end of the study. Living in stable/secure accommodation in the community. 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: Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder. Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression. A clinical diagnosis of post-traumatic stress disorder. Suicidal ideation or behavior at 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 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. Uncontrolled or insulin-dependent diabetes.

Sites / Locations

  • King's College LondonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BPL-003 arm

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with treatment emergent adverse events
Percentage of patients with clinically significant abnormal laboratory tests
Percentage of patients with clinically significant abnormal vital signs
Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS)

Secondary Outcome Measures

Effects on the Mystical Experience Questionnaire (MEQ30)
Effects on the Ego Dissolution Inventory (EDI)
Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30)
Percentage of patients experiencing a an ego dissolution, as assessed by the Ego Dissolution Inventory (EDI)
Description of the BPL-003 subjective experience data, from a qualitative interview
Readiness for discharge questionnaire
Feedback from therapists on the frequency and duration of psychotherapy sessions, therapy manual and overall therapy model

Full Information

First Posted
December 13, 2022
Last Updated
June 19, 2023
Sponsor
Beckley Psytech Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05674929
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beckley Psytech Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to give informed consent. Age 18 to 64 years at Screening. Diagnosed with AUD of severity that may benefit from pharmacologic treatment, ie, moderate to severe AUD. Minimum of 10 heavy drinking days in the 28 days before Screening. No more than 14 days have elapsed since the last HDD or completion of detoxification. Can abstain from the consumption of any alcoholic substances for 72 hours prior to dosing. Willing to abstain from using recreational drugs from Screening until end of the study Willing to abstain from smoking during their time in the clinic on the day of dosing. Willing to refrain from psychedelic drug use from Screening until the end of the study. Living in stable/secure accommodation in the community. 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: Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder. Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression. A clinical diagnosis of post-traumatic stress disorder. Suicidal ideation or behavior at 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 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. Uncontrolled or insulin-dependent diabetes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beckley Psytech Ltd
Phone
+44 (0)1865 987633
Email
Medinfo@beckleypsytech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer, MD, PhD
Organizational Affiliation
Beckley Psytech Ltd
Official's Role
Study Director
Facility Information:
Facility Name
King's College London
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Email
AUD-5MEODMT@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.

Learn more about this trial

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

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