An Open-Label, Single Dose Study in Patients With... — Clinical Trial Details

Open-label Phase IIa treatment study in patients with moderate to severe alcohol use disorder testing a single intranasal administration of BPL-003 combined with structured relapse-prevention psychological support; follow-up assessments extend to 12 weeks.

Primary outcomes focus on safety and tolerability; secondary and exploratory measures include pharmacodynamic effects and alcohol-use outcomes across the 12-week follow-up.

Participants

Ages

18 – 64

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion 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

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) for alcohol use disorder: An open-label, phase 2, proof-of-concept, clinical trial

Integration

Therapeutic Protocol

Study Arms & Interventions

BPL-003 arm

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators