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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beckley Psytech Limited

Criteria

Inclusion Criteria:

1. Willing and able to give informed consent.

2. Age 18 to 64 years at Screening.

3. Diagnosed with AUD of severity that may benefit from pharmacologic treatment, ie, moderate to severe AUD.

4. Minimum of 10 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.

6. Can abstain from the consumption of any alcoholic substances for 72 hours prior to dosing.

7. Willing to abstain from using recreational drugs from Screening until end of the study

8. Willing to abstain from smoking during their time in the clinic on the day of dosing.

9. Willing to refrain from psychedelic drug use from Screening until the end of the study.

10. Living in stable/secure accommodation in the community.

11. 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. Suicidal ideation or behavior at 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.