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Pharmacokinetics, safety, and tolerability of a THC:CBD oil formulation in patients with chronic non-cancer pain on long term high dose opioid analgesia.

Aim This Phase I open label study examined pharmacokinetics, safety, and
tolerability of escalating doses of a combination cannabinoid medication
(1:1 ratio THC:CBD) in patients with chronic non-cancer pain (CNCP) on
high dose opioid analgesia. Methods Nine people with CNCP and oral
morphine equivalent daily dose of ≥60mg were recruited. Blood
concentrations of THC, 11-hydroxytetrahydrocannabinol (OH-THC),
11-nor-9-carboxy-tetrahydrocannabinol (COOH-THC) and CBD were assayed
weekly. Concentrations were measured after a single dose of 2.5mg
THC/2.5mg CBD up to 12.5mg THC/12.5mg CBD on Day 29. Follow-up was on
Day 36 after 7 day washout. Secondary outcome data encompassed pain,
mood, and sleep parameters. Results The parent THC, CBD, OH-THC,
COOH-THC were detected at most time points. In general, the
concentration of all analytes increased until 2 hours
post-administration, decreasing to approximately pre-dose concentrations
by 8 hrs. There was considerable inter- and intra-individual
variability. The study medication was well tolerated. Eight participants
reported at least one Adverse Event (AE), with a total of 62 AEs; most
common were euphoric mood, headache, and agitation, none classified as
severe. There was no significant change to pain severity self-ratings,
nor use of pain medications. Improvements in pain interference scores,
mood, and some sleep parameters were observed. Conclusion The THC:CBD
formulation was tolerated well in a CNCP patient group.
Between-participant variability supports personalized dosing and “start
low-go slow” titration. Improvements in pain, mood, and sleep
parameters suggest that on relatively low dosages clinical effects are
apparent. To validate and quantify findings a comparison placebo group
study is needed.