Alcohol Use DisorderPhase 2NCT05674929
An Open-Label, Single Dose Study in Patients With Alcohol Use Disorder
A Phase 2 study testing BPL-003 in people with Alcohol Use Disorder, run by Beckley Psytech Limited at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- BPL-003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 May 2023to 2 Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Willing and able to give informed consent.
- Age 18 to 64 years at Screening.
- Diagnosed with moderate to severe AUD.
- Minimum of 4 heavy drinking days in the 28 days before Screening.
- 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
- 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.
- 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.
Who cannot join
- 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.
- Suicide ideation or behaviour or self-injurious behaviours within the 12 months before 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Clerkenwell Health
London, W1G 8DR
King's College London
London
About this study
Official title: An Open-Label, Phase 2a Single Dose Study in Patients With Alcohol Use Disorder
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.
Read the 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
- Conditions
- Alcohol Use Disorder
- Being tested
- BPL-003
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPL-003Drug
A single dose administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| BPL-003 arm | Experimental | Not described Receives: Drug: BPL-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment Emergent Adverse Events
The number (%) of participants with at least one treatment-emergent adverse event is presented. More detailed information is provided in the dedicated 'Adverse Events' section
Measured: Up to 12 weeks
Percentage of Participants With Clinically Significant Abnormal Laboratory Tests
The number (%) of participants with any clinically significant abnormal laboratory tests (routine haematology, clinical chemistry and coagulation) is presented
Measured: Up to 12 weeks
Percentage of Participants With Clinically Significant Abnormal Vital Signs
The number (%) of participants with any clinically significant abnormal vital signs (blood pressure, heart rate and temperature) result is presented
Measured: Up to 12 weeks
Number of Participants With Post-baseline Suicidal Ideation or Behaviour Based on C-SSRS Score
The C-SSRS was performed at screening, on Day 0 (dosing day), and on Days 1, 7, and 84 post-dose. Participants were counted if they answered 'yes' to any question. At baseline, the C-SSRS assessed the worst-point suicidal ideation experienced during the participant's lifetime. Beyond baseline, suicidal ideation and behaviour since last visit was assessed.
Measured: Up to 12 weeks
Time to Readiness for Discharge Post-dose Using the Readiness for Discharge Questionnaire (RDQ)
The RDQ was a brief assessment scale to ensure that ahead of discharge after BPL-003 dosing, participants:
- Were fully responsive, aware of their surroundings, and reacted adequately
- The acute psychedelic effects of the drug had completely subsided
- Were fully orientated (name, location, time)
- Had normal (or only slightly elevated) blood pressure and pulse rate, and normal breathing frequency and body temperature
- Had a stable gate, normal muscle coordination, and could walk safely
- Had only mild to moderate potential side affects that did not need to be medically monitored
- Had no acute suicidal ideations or suicidal intentions
- Possible distress or feelings of overwhelm had sufficiently subsided and the participant felt safe to be discharged.
Readiness for discharge was assessed at 90 minutes post-dose and then every 30 minutes until the participant was deemed ready for discharge (eg, the answer was 'yes' to all of the above items).
Measured: 1 Day
Percentage of Participants With Occurrence of Reactivation Using the Reactivation Questionnaire (ReAQ)
The occurrence and (if applicable) frequency, emotional valence, and functional impact of any reactivation events was determined. To determine if reactivation had occurred, participants were asked if they had any flashbacks or recurrence of any effects of the study drug experience.
Measured: Up to 12 weeks
Secondary outcomes (7)
Effects on the Mystical Experience Questionnaire (MEQ-30)
The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence of space and time, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses. The total MEQ-30 score is presented. The higher the score, the greater the mystical experience. A total score of ≥3 was considered to be a significant mystical experience.
Measured: 1 Day
Effects on the Ego Dissolution Inventory (EDI)
The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Higher scores are indicative of more intense ego dissolution. In practice, this means participants with higher scores could have a reduced sense of having a distinct, separate self; greater feelings of unity with the environment or universe; a loss of self-referential thoughts or identity; or altered boundaries between 'self' and 'other'. A 'total EDI score' was calculated for each participant as the average of their individual-item scores. The total EDI score is presented.
Measured: 1 Day
Percentage of Participants With a Complete Mystical Experience Using the MEQ-30
The MEQ-30 was performed to assess the extent of a participant's mystical experience after receiving BPL-003 on Day 0 (dosing day). The questionnaire comprises a list of 30 phenomena, with subscales to measure mystical, positive mood, transcendence, and ineffability factors, measured on a 0 to 5 scale (0=none; not at all to 5=extreme). A 'total MEQ-30 score' was calculated for each participant as the average of all their responses.
A complete mystical experience was defined as reaching or exceeding a score of 3 on all four sub-domains (mystical, positive mood, transcendence of time and space, and ineffability) of the MEQ-30 scale.
Measured: 1 Day
Percentage of Participants Experiencing an Ego Dissolution Using the EDI
The EDI was performed to assess the extent of a participant's dissolution of ego after receiving BPL-003 on Day 0 (dosing day). The inventory comprises 8 statements. Participants rated their agreement to each statement by marking on a visual analogue scale from 0 ("no, not more than usually") to 100 ("yes, entirely or completely"). Participants were classed as experiencing an ego dissolution if they had a total score of >50.0 out of 100 on the EDI scale.
Measured: 1 Day
Description of the BPL-003 Subjective Experience Data, From a Qualitative Interview
After BPL-003 dosing, participants had the option to participate in a one-to-one guided interview with independent researchers trained in microphenomenology methods to describe their psychedelic experience. Temporal aspects of drug effects (e.g., sensory, cognitive, metacognitive, and sense of self/other/connectedness) were elicited through open-ended interview questions.
Measured: Interviews were conducted approximately 2 hours after dosing
Feedback From Therapists on the Frequency and Duration of Psychotherapy Sessions, Therapy Manual and Overall Therapy Model
Key themes from qualitative feedback on the treatment model was sought from therapists on frequency and duration of psychotherapy sessions, implementation of therapy manual, and overall therapy model. Feedback was obtained in a qualitative interview with each therapist after each participant's last integration session (between Day 15 and Day 42).
Measured: 1 Day
Semi-structured Interview to Assess Psychological Changes Following BPL-003 Treatment
After BPL-003 dosing, participants had the option to participate in a semi-structured interview. The interviews were topic-guided, qualitative interviews to understand psychological changes shortly after dosing on Day 1, and on Day 84.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start30 May 2023
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckley Psytech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin Craig, M.D., Study director, Beckley Psytech Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674929
- Sponsor's protocol ID
- BPL-003-203
- Status last verified
- Sep 2025
- First submitted
- 13 Dec 2022
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the UK GDPR, individual participant data will not be shared publicly. Group data will be presented in publication after study completion.