Study register · detail
Clear benefit
GRADE
Moderate
14 citations
Samplen = 24 Pat.
DurationSingle study days with…
ControlPlacebo capsule
EndpointOptic nerve head blood flow
Blindingdoppelblind
DesignRCT
Cannabinoidthc
Max. dose5.0 mg
Routeoral
Key finding
Dronabinol significantly increased optic nerve head blood flow (ONHBF) by 9,5% at rest, while placebo showed no effect.
Summary
n=24 healthy subjects, randomised, placebo-controlled crossover study of 5 mg dronabinol (synthetic THC) oral. Primary finding: dronabinol increased Optic Nerve Head Blood Flow (ONHBF) at rest by 9,5±8,1% vs. baseline (placebo 0,3±7,4%, p<0,001 between study days). No effect on IOP, MAP or Ocular Perfusion Pressure (OPP); no psychoactive side effects. Autoregulatory response of ONHBF to isometric exercise unchanged. Well tolerated; translation to glaucoma patients still pending.
P
PopulationHealthy subjects, n=24
I
InterventionOral dronabinol (synthetic THC) 5 mg single dose, capsule
C
ControlPlacebo capsule
O
OutcomeDronabinol significantly increased optic nerve head blood flow (ONHBF) at rest by 9,5 ± 8,1% vs. placebo 0,3 ± 7,4% (p<0,001); no effect on IOP, MAP or OPP
Confidence in the evidence
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size
★★★★★
Blinding
Double-blind
Effect size
Clear benefit
Citations / year
★★★★★
Authors
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Abstract
It has been hypothesized that besides its intraocular pressure (IOP) lowering potential, tetrahydrocannabinol (THC) may also improve ocular hemodynamics. The aim of the present study was to investigate whether single oral administration of dronabinol, a synthetic THC, alters optic nerve head blood flow (ONHBF) and its regulation in healthy subjects. The study was carried out in a randomized, placebo-controlled, double-masked, two-way crossover design in 24 healthy subjects. For each study participant, 2 study days were scheduled, on which they either received capsules containing 5 mg dronabinol or placebo. ONHBF was measured with laser Doppler flowmetry at rest and while the study participants performed isometric exercise for 6 minutes to increase mean arterial blood pressure (MAP). This was repeated 1 hour after drug intake. Ocular perfusion pressure (OPP) was calculated as 2/3MAP-IOP. Dronabinol was well tolerated and no cannabinoid-related psychoactive effects were reported. Neither administration of dronabinol nor placebo had an effect on IOP, MAP, or OPP. In contrast, dronabinol significantly increased ONHBF at rest by 9.5 +/- 8.1%, whereas placebo did not show a change in ONHBF (0.3 +/- 7.4% vs. baseline, P < 0.001 between study days). Dronabinol did not alter the autoregulatory response of ONHBF to isometric exercise. In conclusion, the present data indicate that low-dose dronabinol increases ONHBF in healthy subjects without affecting IOP, OPP, or inducing psychoactive side effects. In addition, dronabinol does not alter the autoregulatory response of ONHBF to an experimental increase in OPP. Further studies are needed to investigate whether this effect can also be observed in patients with glaucoma.
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