Alcohol Use Disorder
Conditions
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.
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
Interventions
DRUGBPL-003
A single dose administered intranasally
Sponsors
Beckley Psytech Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events | Up to 12 weeks | 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 |
| Percentage of Participants With Clinically Significant Abnormal Laboratory Tests | Up to 12 weeks | The number (%) of participants with any clinically significant abnormal laboratory tests (routine haematology, clinical chemistry and coagulation) is presented |
| Percentage of Participants With Clinically Significant Abnormal Vital Signs | Up to 12 weeks | The number (%) of participants with any clinically significant abnormal vital signs (blood pressure, heart rate and temperature) result is presented |
| Number of Participants With Post-baseline Suicidal Ideation or Behaviour Based on C-SSRS Score | Up to 12 weeks | 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. |
| Time to Readiness for Discharge Post-dose Using the Readiness for Discharge Questionnaire (RDQ) | 1 Day | 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). |
| Percentage of Participants With Occurrence of Reactivation Using the Reactivation Questionnaire (ReAQ) | Up to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on the Mystical Experience Questionnaire (MEQ-30) | 1 Day | 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. |
| Effects on the Ego Dissolution Inventory (EDI) | 1 Day | 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. |
| Percentage of Participants With a Complete Mystical Experience Using the MEQ-30 | 1 Day | 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. |
| Percentage of Participants Experiencing an Ego Dissolution Using the EDI | 1 Day | 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. |
| Description of the BPL-003 Subjective Experience Data, From a Qualitative Interview | Interviews were conducted approximately 2 hours after dosing | 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. |
| Feedback From Therapists on the Frequency and Duration of Psychotherapy Sessions, Therapy Manual and Overall Therapy Model | 1 Day | 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). |
| Semi-structured Interview to Assess Psychological Changes Following BPL-003 Treatment | Up to 12 weeks | 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. |
Countries
United Kingdom
Contacts
STUDY_DIRECTORKevin Craig, M.D.
Beckley Psytech Ltd
Participant flow
Recruitment details
Participants were recruited to the study between 29 March 2023 and 02 July 2024 from community treatment services for addiction, or by community advertisement.
Pre-assignment details
Participants were expected to have no heavy drinking days at least 72 hours before BPL-003 dosing and no alcohol at all in the 24 hours before BPL-003 dosing. Participants also took part in 3 psychedelic preparation sessions over about 2 weeks before BPL-003 dosing.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.3 Years STANDARD_DEVIATION 10.77 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of participants with any lifetime suicidal ideation or behaviour based on C-SSRS score | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United Kingdom | 13 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 11 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
None listed