Study register · detailRCT · Sleep Disorders · 2024
Evaluating possible 'next day' impairment in insomnia patients administered an oral medicinal cannabis product by night: a pilot randomized controlled trial.
Suraev et al.·PsychopharmacologyImpact 2.8
MixedGRADEModerate9 citations
Samplen = 20 Pat.
Durationtwo 24-hour laboratory visits
ControlMatched placebo
EndpointCognitive and psychomotor…
Blindingdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD1:20
Max. dose210.0 mg
Routeoral
”Key finding
No notable next-day impairment in cognitive and psychomotor function or driving simulation; a small deterioration in the Stroop test and a slight increase in perceived sedation without clinical relevance.
Summary
n=20 adults with insomnia (16 female, mean age 46,1 years), randomised double-blind crossover to 10 mg THC + 200 mg CBD vs. placebo. No 'next day' impairment in 27/28 cognitive and psychomotor tests (≥9h post-treatment). Small reduction (-1,4%, p=0,016, d=-0,6) in Stroop colour task accuracy; small increase (+8,6, p=0,042, d=0,3) in sedation rating after 10h. No differences in simulated driving performance vs. placebo.
P
PopulationAdults with insomnia (infrequent cannabis users), n=20, 16 female, mean age 46,1 years
I
InterventionOral cannabis oil 10 mg THC + 200 mg CBD in the evening, single dose, crossover
C
ControlMatched placebo (oral, crossover)
O
OutcomeNo significant 'next-day' performance decline in 27 of 28 tests of cognition, psychomotor function and simulated driving; minimal decrease in Stroop-congruent accuracy (−1,4%, p=0,016, d=−0,6) and slight increase in sedation after 10 h (+8,6, p=0,042, d=0,3)
Confidence in the evidence
Very lowLowModerateHigh
Moderate
The third of four GRADE levels, the effect estimate is probably reliable.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
BlindingDouble-blind
Effect sizeMixed
Citations / year★★★★★
Authors
Suraev A, McCartney D, Marshall NS, Irwin C, Vandrey R, Grunstein RR, D'Rozario AL, Gordon C, Bartlett D, Hoyos CM
Cannabis and its major constituents, Delta(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD), are being widely used to treat sleep disturbances. However, THC can cause acute cognitive and psychomotor impairment and there are concerns that driving and workplace safety might be compromised the day after evening use. Here, we examined possible 'next day' impairment following evening administration of a typical medicinal cannabis oil in adults with insomnia disorder, compared to matched placebo. This paper describes the secondary outcomes of a larger study investigating the effects of THC/CBD on insomnia disorder. Twenty adults [16 female; mean (SD) age, 46.1 (8.6) y] with physician-diagnosed insomnia who infrequently use cannabis completed two 24 h in-laboratory visits involving acute oral administration of combined 10 mg THC and 200 mg CBD ('THC/CBD') or placebo in a randomised, double-blind, crossover trial design. Outcome measures included 'next day' (>/=9 h post-treatment) performance on cognitive and psychomotor function tasks, simulated driving performance, subjective drug effects, and mood. We found no differences in 'next day' performance on 27 out of 28 tests of cognitive and psychomotor function and simulated driving performance relative to placebo. THC/CBD produced a small decrease (-1.4%, p=.016, d=-0.6) in accuracy on the Stroop-Colour Task (easy/congruent) but not the Stroop-Word Task (hard/incongruent). THC/CBD also produced a small increase (+8.6, p=.042, d=0.3) in self-ratings of Sedated at 10 h post-treatment, but with no accompanying changes in subjective ratings of Alert or Sleepy (p's>0.05). In conclusion, we found a lack of notable 'next day' impairment to cognitive and psychomotor function and simulated driving performance following evening use of 10 mg oral THC, in combination with 200 mg CBD, in an insomnia population who infrequently use cannabis.