An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BPL-003 arm
|
Drug: BPL-003
A single dose administered intranasally
|
Outcome Measures
Primary Outcome Measures
- Percentage of patients with treatment emergent adverse events [Up to12 weeks]
- Percentage of patients with clinically significant abnormal laboratory tests [Up to12 weeks]
- Percentage of patients with clinically significant abnormal vital signs [Up to12 weeks]
- Percentage of patients with suicidal ideation and changes in Columbia Suicidality Rating Scores (CSSRS) [Up to12 weeks]
Secondary Outcome Measures
- Effects on the Mystical Experience Questionnaire (MEQ30) [1 Day]
- Effects on the Ego Dissolution Inventory (EDI) [1 Day]
- Percentage of patients experiencing a complete mystical experience, as assessed by the Mystical Experience Questionnaire (MEQ30) [1 Day]
- Percentage of patients experiencing a an ego dissolution, as assessed by the Ego Dissolution Inventory (EDI) [1 Day]
- Description of the BPL-003 subjective experience data, from a qualitative interview [1 Day]
- Readiness for discharge questionnaire [1 Day]
- Feedback from therapists on the frequency and duration of psychotherapy sessions, therapy manual and overall therapy model [1 Day]
Other Outcome Measures
- Timeline Follow-Back (TLFB) interview to assess the number of days abstinent from alcohol [Up to 12 weeks]
- Timeline Follow-Back (TLFB) interview to assess the longest duration of continuous alcohol abstinence [Up to 12 weeks]
- Timeline Follow-Back (TLFB) interview to assess the number of days after BPL-003 dosing to first drink [Up to 12 weeks]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Willing and able to give informed consent.
-
Age 18 to 64 years at Screening.
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Diagnosed with AUD of severity that may benefit from pharmacologic treatment, ie, moderate to severe AUD.
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Minimum of 10 heavy drinking days in the 28 days before Screening.
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No more than 14 days have elapsed since the last HDD or completion of detoxification.
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Can abstain from the consumption of any alcoholic substances for 72 hours prior to dosing.
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Willing to abstain from using recreational drugs from Screening until end of the study
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Willing to abstain from smoking during their time in the clinic on the day of dosing.
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Willing to refrain from psychedelic drug use from Screening until the end of the study.
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Living in stable/secure accommodation in the community.
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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:
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Personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder.
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Any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression.
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A clinical diagnosis of post-traumatic stress disorder.
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Suicidal ideation or behavior at Screening.
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Regular use of or dependence on other drugs other than caffeine or nicotine.
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Any self-reported use of psychedelic compounds in the past 6 months.
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History of seizures.
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Patients who are exhibiting any signs of alcohol withdrawal on dosing day.
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Positive for alcohol on dosing day.
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Positive urine drug screen for illicit drugs or drugs of abuse.
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Any nasal obstruction, blockage, or symptoms of congestion.
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Any personal or family history of malignant hyperthermia.
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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.
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Uncontrolled or insulin-dependent diabetes.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | King's College London | London | United Kingdom |
Sponsors and Collaborators
- Beckley Psytech Limited
Investigators
- Study Director: Chief Medical Officer, MD, PhD, Beckley Psytech Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPL-003-203