Table 1.
Study | Year | Indication | Length of treatment | Total CBD dose/daya | Type of CBD | Food directions | Number of participants | Age inclusion criteria | Mean age | Male (%) | Clobazam co-prescription (%) | Valproate co-prescription (%) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Consroe et al. [26] | 1991 | Huntington’s Disease | 6 weeksb | 10 mg/kg | Not specified | Empty stomach with a glass of water | 18 | – | 47.8 | 61.1 | 0 | 0 |
GWP Fatty Liver Disease NCT01284634 [3] | 2014 | Fatty Liver Disease | 8 weeks | 200/400/800 mg | Plant derived (GWP42003) | Fasted, 30 min before meal | 25 | 18+ | 46.4 | 48 | – | – |
Jadoon et al. [2] | 2016 | Type II Diabetes | 13 weeks | 200 mg | Plant derived (GWP42003) | Fasted, 30 min before meal | 27 | 18+ | 57.7 | 63 | – | – |
Naftali et al. [25]c | 2017 | Crohn’s Disease | 8 weeks | 20 mg sublingual | Plant derived | – | 19 | 18–75 | 39 | 57.9 | – | – |
Devinsky et al. (GWPCARE1) [18] | 2017 | Dravet Syndrome | 11 days titration and 12 weeks maintenance treatment up to 10 days taper period or OLE | 20 mg/kg | GWP42003-P, plant derived | – | 120 | 2–18 | 9.8 | 52 | 65 | 59 |
Boggs et al. [19] | 2018 | Schizophrenia | 6 weeks | 600 mg | Provided by STI Pharmaceuticals | – | 41 | 18–65 | 47.4 | 69.4 | – | ?d |
McGuire et al. [4] | 2018 | Schizophrenia | 6 weeks | 1000 mg | Plant derived (GWP42003) | – | 88 | 18–65 | 40.8 | 58 | – | – |
GWP Clobazam Interaction Study NCT02565108 [20] | 2018 | Clobazam | 10 days titration and 21 days maintenance treatment 10 day taper period or OLE | 20 mg/kg | Plant derived (GWP42003-P) | – | 20 | 18–65 | 36.8 | 50 | 100 | – |
Devinsky et al. (GWPCARE1 – Dose Ranging) [21] | 2018 | Dravet Syndrome | 3, 7 or 11 days titration 21 days maintenance treatment 10 days taper period or OLE | 5/10/20 mg/kg | Plant derived (GWP42003-P) | – | 34 | 4–10 | 7.6 | 47 | 68 | 65 |
Devinsky et al. (GWPCARE3) [17] | 2018 | Lennox-Gastaut Syndrome | 7 or 11 days titration 12 weeks maintenance treatment 10 days taper period or OLE | 10/20 mg/kg | Plant derived (GWP42003-P) | – | 225 | 2–55 | 15.6 | 57.3 | 49 | 38 |
Thiele et al. (GWPCARE4) [22] | 2018 | Lennox-Gastaut Syndrome | 11 days titration 12 weeks maintenance treatment 10 days taper period or OLE | 20 mg/kg | Plant derived (GWP42003-P) | – | 171 | 2–55 | 15.4 | 51.5 | 49 | 40 |
Taylor et al. [23] | 2018 | Healthy Adults | 1 week | 1.5 g or 3 g per day (half dose on day 7) | Plant derived (GWP42003) | – | 24 | 18–45 | 26 | 33.3 | – | – |
Hill et al. NCT03102918 [24] | 2019 | Cannabis Use Disorder | 6 weeks | 800 mg | Plant derived (GWP42003) | – | 10 | 18–65 | 30.8 | 40 | 0 | 0 |
OLE open-label extension.
aOral dosing unless stated otherwise.
bCrossover study with a 1 week washout and second 6 weeks treatment period, only pre-crossover data were extracted.
cNaftali 2017 met all inclusion criteria but did not contribute data to meta-analysis.
d25% of participants were prescribed a mood stabilizer which may include valproate.