• Outcome measures in cannabinoid trials should include pain intensity, and in the context of chronic pain also the assessment of effects on sleep, quality of life, function, and the affective-motivational and cognitive dimensions of the pain experience, particularly those most important from the patient perspective. |
• Dose and titration methods (if applicable) should be explicit; placebo and active comparators should be encouraged, as should studies examining cannabis, cannabinoids or CBM administered both as monotherapy and adjunctively with other pain medications. |
• Analysis of patient demographic, phenotypic and genotyping characteristics pertinent to a possible personalized treatment response are desirable, and should be adequately powered. |
• Investigation of relationships between cannabinoid plasma/target concentrations and pharmacodynamics effects, for both efficacy and toxicity endpoints. |
• High quality trials studying cannabidiol (CBD) in specific pain conditions. |
• High quality trials studying those cannabinoids, endocannabinoid system modulators and CBMs that show most promise in preclinical studies. |
• Further conduct of experimental pain study designs with cannabinoids that would translate to meaningful clinically-relevant analgesia. |
• Investigation of interactions between opioid-based and cannabinoid-based interventions on: 1) analgesic efficacy, 2) side effect profile - e.g. abuse liability, respiratory depression, 3) change in or inhibition of withdrawal symptoms during opioid tapering or abstinence. |
• Determination of optimal therapeutic ratios of cannabinoids (e.g. THC:CBD) in particular pain conditions; e.g. strategies that attempt to separate analgesia from adverse effects. |
• High-quality trials with inhaled/vaporized cannabinoids, with adequately powered sample size, sufficient duration, detailed pharmacokinetic analysis, and rigorous controls. |
• High quality population health-based studies that yield useful ‘real-world’ data on the benefits and harms of cannabis, cannabinoids and CBM in large numbers of people with pain. |
• Unified quantification of major/minor phytocannabinoid content for cannabis preparations evaluated in clinical trials. |
• Determination of the effects of regulatory restrictions on cannabinoid clinical research. |