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En åben-label, enkeltdosis undersøgelse hos patienter med alkoholmisbrug

21. maj 2026 opdateret af: Beckley Psytech Limited

Et åbent, fase 2a enkeltdosisstudie i patienter med alkoholforbrug

Et åbent, fase 2a-studie for at evaluere sikkerheden, tolerabiliteten og farmakodynamiske virkninger af en enkelt intranasal dosis af BPL-003 kombineret med tilbagefaldsforebyggende psykologisk støtte, for at udforske de potentielle virkninger på alkoholbrug og relaterede symptomer hos patienter med alkoholbrug. Sygdom.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Cirka 12 kvalificerede deltagere vil modtage en enkelt dosis BPL-003, givet intranasalt, med 12 ugers opfølgningsvurderinger. Psykologisk støtte vil blive givet før, under og efter dosering

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • London, Det Forenede Kongerige
        • King's College London
      • London, Det Forenede Kongerige, W1G 8DR
        • Clerkenwell Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Villig og i stand til at give informeret samtykke.
  2. Alder 18 til 64 år på Screening.
  3. Diagnosticeret med AUD af sværhedsgrad, der kan have gavn af farmakologisk behandling, dvs. moderat til svær AUD.
  4. Minimum 10 tunge drikkedage i de 28 dage før screening.
  5. Der er ikke gået mere end 14 dage siden sidste HDD eller afslutning af afgiftning.
  6. Kan afholde sig fra indtagelse af alkoholiske stoffer i 72 timer før dosering.
  7. Villig til at afholde sig fra at bruge rekreative stoffer fra screening indtil afslutningen af ​​undersøgelsen
  8. Er villig til at afholde sig fra rygning under deres ophold i klinikken på doseringsdagen.
  9. Villig til at afholde sig fra psykedelisk stofbrug fra Screening indtil afslutningen af ​​undersøgelsen.
  10. Bor i stabil/sikker bolig i samfundet.
  11. I besiddelse af en personlig mobiltelefon og i stand til at nominere mindst én lokaliseringsperson (f.eks. et familiemedlem, en ven eller en helbredelsesmentor) med en verificerbar adresse og et telefonnummer til at hjælpe med at arrangere opfølgende aftaler.

Ekskluderingskriterier:

  1. Personlig eller førstegrads familiehistorie med skizofreni, bipolar lidelse, psykotisk lidelse, vrangforestillingslidelse, paranoid lidelse eller skizoaffektiv lidelse.
  2. Alle større psykiatriske lidelser, med undtagelse af mild eller moderat angst og/eller depression.
  3. En klinisk diagnose af posttraumatisk stresslidelse.
  4. Selvmordstanker eller -adfærd ved screening.
  5. Regelmæssig brug af eller afhængighed af andre stoffer end koffein eller nikotin.
  6. Enhver selvrapporteret brug af psykedeliske forbindelser inden for de seneste 6 måneder.
  7. Historie om anfald.
  8. Patienter, der udviser tegn på alkoholabstinenser på doseringsdagen.
  9. Positiv for alkohol på doseringsdagen.
  10. Positiv urinstofscreening for ulovlige stoffer eller misbrugsstoffer.
  11. Enhver næseblokering, blokering eller symptomer på overbelastning.
  12. Enhver personlig eller familiehistorie med malign hypertermi.
  13. Patienter med en ukontrolleret kardiovaskulær lidelse, der efter Investigators opfattelse kan forstyrre fortolkningen af ​​undersøgelsesresultater eller udgøre en sundhedsrisiko for patienten, hvis han/hun deltager i undersøgelsen.
  14. Ukontrolleret eller insulinafhængig diabetes.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: BPL-003 arm
Medicin: BPL-003
En enkelt dosis administreret intranasalt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Treatment Emergent Adverse Events
Tidsramme: 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
Up to 12 weeks
Percentage of Participants With Clinically Significant Abnormal Laboratory Tests
Tidsramme: Up to 12 weeks
The number (%) of participants with any clinically significant abnormal laboratory tests (routine haematology, clinical chemistry and coagulation) is presented
Up to 12 weeks
Percentage of Participants With Clinically Significant Abnormal Vital Signs
Tidsramme: Up to 12 weeks
The number (%) of participants with any clinically significant abnormal vital signs (blood pressure, heart rate and temperature) result is presented
Up to 12 weeks
Number of Participants With Post-baseline Suicidal Ideation or Behaviour Based on C-SSRS Score
Tidsramme: 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.
Up to 12 weeks
Time to Readiness for Discharge Post-dose Using the Readiness for Discharge Questionnaire (RDQ)
Tidsramme: 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).
1 Day
Percentage of Participants With Occurrence of Reactivation Using the Reactivation Questionnaire (ReAQ)
Tidsramme: 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.
Up to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effects on the Mystical Experience Questionnaire (MEQ-30)
Tidsramme: 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.
1 Day
Effects on the Ego Dissolution Inventory (EDI)
Tidsramme: 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.
1 Day
Percentage of Participants With a Complete Mystical Experience Using the MEQ-30
Tidsramme: 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.
1 Day
Percentage of Participants Experiencing an Ego Dissolution Using the EDI
Tidsramme: 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.
1 Day
Description of the BPL-003 Subjective Experience Data, From a Qualitative Interview
Tidsramme: 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.
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
Tidsramme: 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).
1 Day
Semi-structured Interview to Assess Psychological Changes Following BPL-003 Treatment
Tidsramme: 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.
Up to 12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timeline Follow-Back (TLFB) Interview to Assess the Percentage of Abstinent Days (PAD)
Tidsramme: Up to 12 weeks
Using the TLFB interview, the PAD in the 85 days before Day -3 (or start of detox) vs the PAD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.
Up to 12 weeks
TLFB Interview to Assess the Percentage of Heavy Drinking Days (PHDD)
Tidsramme: Up to 12 weeks
Using the TLFB interview, the PHDD in the 85 days before Day -3 (or start of detox) vs PHDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.
Up to 12 weeks
TLFB Interview to Assess the Percentage of Drinking Days (PDD)
Tidsramme: Up to 12 weeks
Using the TLFB interview, the PDD in the 85 days before Day -3 (or start of detox) vs PDD post-dosing measured on Days 14, 28, 56, and 84 were determined to assess alcohol use.
Up to 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beckley Psytech Limited

Efterforskere

  • Studieleder: Kevin Craig, M.D., Beckley Psytech Ltd

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. maj 2023

Primær færdiggørelse (Faktiske)

2. oktober 2024

Studieafslutning (Faktiske)

2. oktober 2024

Datoer for studieregistrering

Først indsendt

13. december 2022

Først indsendt, der opfyldte QC-kriterier

21. december 2022

Først opslået (Faktiske)

9. januar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. september 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BPL-003-203

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

På grund af UK GDPR vil individuelle deltagerdata ikke blive delt offentligt. Gruppedata vil blive præsenteret i publikation efter undersøgelsens afslutning.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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