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Psychedelic nasal spray shows promise for alcohol addiction in small trial

NCT ID NCT05674929

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a single nasal spray dose of BPL-003, a psychedelic drug, combined with psychological support in 13 adults with moderate to severe alcohol use disorder. The main goals were to check safety and tolerability, and to explore effects on drinking behavior. The study is complete, but results on effectiveness are not yet reported.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BPL-003 (a psychedelic drug given as a nasal spray)
What this could lead to
If successful, this could point toward a new treatment option for alcohol use disorder that combines a single drug dose with psychological support.
What could go wrong
This is a very small, early-phase study with only 13 participants, so results may not apply broadly. The drug may cause side effects or fail to reduce alcohol use in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

13 people

The number who actually took part.

Started

May 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clerkenwell Health

    London, W1G 8DR, United Kingdom

  • King's College London

    London, United Kingdom

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