Effect of delta-9-tetrahydrocannbinol (THC) on obstructive sleep apnoea and the mechanisms which cause it.

Effect of delta-9-tetrahydrocannabinol on obstructive sleep apnoea severity and its pathophysiological contributors in adults aged 25-70 years.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000573459

Enrollment

Registered

2025-06-03

Start date

2025-06-26

Completion date

Unknown

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Clinically significant obstructive sleep apnoea (OSA) affects approximately 30% of the middle-aged population and contributes to long term poor health. Four main physiological mechanisms cause OSA, but current treatments typically only address one of these mechanisms and they are not well tolerated. A pharmaceutical therapy for OSA is desired by patients and has the potential to treat more than one of the mechanisms causing it. This study will examine the effect of a commonly prescribed medicinal cannabis product (delta-9-tetrahydrocannabinol, THC) on the mechanisms that contribute to OSA, its impact on OSA severity and effects on psychomotor and cognitive function. We hypothesise that compared to placebo, 10mg of medicinal THC will decrease the severity of OSA and beneficially alter some of the mechanisms which cause OSA without having a detrimental effect on next-day psychomotor and cognitive function.

Interventions

Oral delta-9-tetrahydrocannabinol (THC) 10mg gel capsule/night, approximately 1 hour prior to bedtime. Taken on a single night at least 1-week prior to, or 1-week following, placebo night. Self-administered under scientist supervision.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

25 Years to 70 Years

Healthy volunteers

Inclusion criteria

Presence of obstructive sleep apnoea (apnoea hypopnoea index (AHI)>10events/hr)

Exclusion criteria

Current use of OSA therapy BMI >35 kg/m2, History of recent (twice monthly over the previous 2 years) cannabis use Currently taking medications known to affect OSA endotypes or interact with the study medication Untreated cardiovascular disease History of significant psychiatric disorder (DASS depression score>/=11, DASS anxiety score>/=8), past suicide attempt, current suicidal ideation (Q9 of PHQ-9>0) Pregnant/breastfeeding Unwilling to abstain from driving for 24 hours after taking the study medication.

Outcome results