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Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study (CANISLEEP)

15. juni 2026 opdateret af: King's College London
The goal of this study is to learn about the body's response to cannabis based products in sleep deprived people who are currently experiencing anxiety but are otherwise healthy.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Rationale The stress response is a biological cascade of physiological, psychological and behavioural processes allowing individuals to detect, interpret and react to perceived or actual threat. In the modern world, sleep loss is increasingly common, can be caused by stress, and can exaggerate the stress response in otherwise healthy individuals. Previous research using sleep restriction approaches has demonstrated that a loss of sleep reliably increases physical and psychological feelings of stress. The endocannabinoid system (ECS) is a network of receptors that regulates both the stress response and sleep processes, making it a suitable target to allow the study of these processes. Cannabinoids are compounds naturally occurring in the Cannabis plant that act on the ECS.

Approach This study will investigate the effects of different cannabinoid oils on physiological and psychological measures of stress following sleep restriction.

Participants will be healthy adults between the ages of 18-60 who are currently experiencing higher than average stress. Participants will undergo a previously validated sleep restriction paradigm (sleeping for 4 hours only) prior to the experimental session. This will allow the research team to safely replicate heightened stress related to poor sleep. Participants will be enrolled in the study for a minimum of 2 days and a maximum of 9 days.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Det Forenede Kongerige
    • London
      • London, London, Det Forenede Kongerige, SE5 8BB
        • Rekruttering
        • The Centre for Mental Health Research and Innovation
        • Kontakt:
        • Ledende efterforsker:
          • Will Lawn, PhD
        • Underforsker:
          • James JH Rucker, MRC Psych, PhD

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

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Aged 18-60
  2. Currently experiencing higher than average anxiety (measured by a score of ≥10 on the GAD-7)
  3. Able and willing to restrict their sleep to 4 hours on one occasion
  4. Willing to restrict alcohol and recreational drug intake during time on the study, confirmed by negative urine drug screen on the day of the experimental session
  5. Own a functioning phone and be able to respond to text messages
  6. Willing to provide GP details
  7. Willing to provide an emergency contact
  8. Able to provide written informed consent
  9. Willing to use a highly effective contraceptive method (see Section 5.2.2) for the duration of the study.

Exclusion Criteria:

  1. Currently receiving any treatment for any psychiatric disorder (medication and/or professional psychotherapy for a mental disorder)
  2. Any cannabinoid use in the past 3 months, including CBD oil, medical cannabinoids or recreational cannabis/THC use
  3. Cannabinoid contraindications: lifetime history of psychosis, 1st degree relative with psychosis, lifetime substance use disorder (that was professionally treated)
  4. History of consistent (>12 months) monthly cannabis use
  5. Currently experiencing insomnia or irregular sleep pattern (e.g. night shift work)
  6. Sleep restriction contraindications (sleep apnoea, sleep movement disorder, night shift work, insomnia)
  7. Have excessive daily caffeine intake (>4 cups of coffee per day or equivalent)
  8. Unlikely to be able to complete the study procedures for any reason, as judged by the study team
  9. Currently pregnant or lactating
  10. Currently trying to conceive a child

Additional criteria which must be met on experimental visits:

  1. Negative urine drug screen
  2. Negative urine pregnancy test
  3. Negative alcohol breath test

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 2.5mg THC
2.5mg tetrahydrocannabinol oil
Medicin: THC
2.5mg tetrahydrocannabinol oil
Aktiv komparator: 300mg CBD
300mg cannabidiol oil
Medicin: CBD
300mg cannabidiol oil
Aktiv komparator: 2.5mg THC + 300mg CBD
2.5mg THC + 300mg CBD (Combined arm)
Medicin: THC + CBD
2.5mg THC + 300mg CBD
Placebo komparator: Placebo
Placebo oil
Medicin: Placebo
Placebo oil

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Threat-minus-safe tonic skin conductance level difference score, measured in μS
Tidsramme: 90-150minutes post dose
Electrodermal activity will be recorded using electrodes on the palms. The skin conductance level is the tonic galvanic skin response, a physiological measurement of how the electrical conductivity of the skin changes in response physical stimuli (mild electric shocks)
90-150minutes post dose

Samarbejdspartnere og efterforskere

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

Sponsor

King's College London

Samarbejdspartnere

South London and Maudsley NHS Foundation Trust

Efterforskere

  • Ledende efterforsker: Will Lawn, PhD, King's College London

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)

2. juni 2026

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HR-25/26-54274

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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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