NCT07656350

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Jun 2026Dec 2027

Study Start

First participant enrolled

June 2, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 8, 2026

Last Update Submit

June 15, 2026

Conditions

Healthy Volunteer

Keywords

THCCBDCannabisStressAnxiety

Outcome Measures

Primary Outcomes (1)

  • Threat-minus-safe tonic skin conductance level difference score, measured in μS

    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

Study Arms (4)

2.5mg THC

EXPERIMENTAL

2.5mg tetrahydrocannabinol oil

Drug: THC

300mg CBD

ACTIVE COMPARATOR

300mg cannabidiol oil

Drug: CBD

2.5mg THC + 300mg CBD

ACTIVE COMPARATOR

2.5mg THC + 300mg CBD (Combined arm)

Drug: THC + CBD

Placebo

PLACEBO COMPARATOR

Placebo oil

Drug: Placebo

Interventions

THCDRUG

2.5mg tetrahydrocannabinol oil

2.5mg THC
CBDDRUG

300mg cannabidiol oil

300mg CBD
THC + CBDDRUG

2.5mg THC + 300mg CBD

2.5mg THC + 300mg CBD
PlaceboDRUG

Placebo oil

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-60
  • Currently experiencing higher than average anxiety (measured by a score of ≥10 on the GAD-7)
  • Able and willing to restrict their sleep to 4 hours on one occasion
  • 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
  • Own a functioning phone and be able to respond to text messages
  • Willing to provide GP details
  • Willing to provide an emergency contact
  • Able to provide written informed consent
  • Willing to use a highly effective contraceptive method (see Section 5.2.2) for the duration of the study.

You may not qualify if:

  • Currently receiving any treatment for any psychiatric disorder (medication and/or professional psychotherapy for a mental disorder)
  • Any cannabinoid use in the past 3 months, including CBD oil, medical cannabinoids or recreational cannabis/THC use
  • Cannabinoid contraindications: lifetime history of psychosis, 1st degree relative with psychosis, lifetime substance use disorder (that was professionally treated)
  • History of consistent (\>12 months) monthly cannabis use
  • Currently experiencing insomnia or irregular sleep pattern (e.g. night shift work)
  • Sleep restriction contraindications (sleep apnoea, sleep movement disorder, night shift work, insomnia)
  • Have excessive daily caffeine intake (\>4 cups of coffee per day or equivalent)
  • Unlikely to be able to complete the study procedures for any reason, as judged by the study team
  • Currently pregnant or lactating
  • Currently trying to conceive a child
  • Additional criteria which must be met on experimental visits:
  • Negative urine drug screen
  • Negative urine pregnancy test
  • Negative alcohol breath test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Mental Health Research and Innovation

London, London, SE5 8BB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Marijuana AbuseAnxiety Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Will Lawn, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine I V Bird, MSc

CONTACT

+44(0)2032281590catherine.bird@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 18, 2026

Study Start

June 2, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations

GB(1)