Evaluating possible 'next day' impairment in insomnia patients administered an oral medicinal cannabis product by night: a pilot randomized controlled trial
- PMID: 38758300
- PMCID: PMC11339085
- DOI: 10.1007/s00213-024-06595-9
Evaluating possible 'next day' impairment in insomnia patients administered an oral medicinal cannabis product by night: a pilot randomized controlled trial
Abstract
Cannabis and its major constituents, Δ9-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.
Keywords: cannabinoids, cognition; driving performance; sleep disorders, next day function.
© 2024. The Author(s).
Conflict of interest statement
ISM is Academic Director of the Lambert Initiative for Cannabinoid Therapeutics, a philanthropically funded research program at the University of Sydney. He has served as an expert witness in various medicolegal cases involving cannabis and has received consulting fees from Medical Cannabis Industry Australia (MCIA) and Janssen. He currently acts as an advisor/consultant to Kinoxis Therapeutics, Psylo and Emyria. He reports research grants and salary support from the Australian National Health and Medical Research Council (NHMRC) and from Lambert Initiative for Cannabinoid Therapeutics. He is an inventor on patents WO2018107216A1 and WO2017004674A1, licensed to Kinoxis Therapeutics involving use of novel small molecules (non-cannabinoid) to treat addictions and social deficits. ISM also has patents WO2020102857A1 and WO2021042178A1 related to use of small molecules (non-cannabinoid) for treating weight gain and opioid withdrawal, as well as patents WO2019227167 and WO2019071302 issued, which relate to cannabinoid therapeutics. CMH (GTN1104003) was supported by Dementia Research Development Fellowships of the Australian National Health and Medical Research Council-Australian Research Council (NHMRC-ARC) and by a National Heart Foundation Future Leader Fellowship. AS was supported by the Australian Government Research Training Program (RTP) and the Vice-Chancellor’s Research Scholarship (VCRS) at the University of Sydney. AS has received consulting fees from the Medical Cannabis Industry Australia (MCIA) and Haleon (consumer healthcare subsidiary of Glaxo Smith-Kline). RRG was supported by NHMRC Senior Principal Research and Investigator Fellowships (GTN1106974/1197439) and has received a speaker fee from Eisai. ALD (NHMRC-ARC Dementia Research Development Fellowship GNT1107716 and NHMRC Emerging Leadership II Investigator Grant GNT2008001). RV has received compensation as a consultant or advisory board member for Jazz Pharmaceuticals, Mira1A Pharmaceuticals, Charlotte’s Web, Canopy Health Innovations, WebMD, and Syqe Medical Ltd. All other authors have no competing financial or non-financial interests to declare. The investigational product was purchased from BOD Australia who were not involved in the conception or design of this study, data analysis (with no access to the data) or the decision to publish. All other commercially available equipment was purchased.
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