Patient Experiences With Prescription Cannabinoids in Germany: Protocol for a Mixed Methods, Exploratory, and...

Area of Science:

• Medical research
• Clinical pharmacology
• Public health

Background:

• Medical cannabinoid use is increasing but remains controversial.
• Prescribing medical cannabinoids is permitted in Germany for various conditions since 2017.
• Patient surveys are challenging due to stigma and low prevalence, hindering data collection on therapy effectiveness and side effects.

Purpose of the Study:

• To conduct an exploratory, representative data collection on current medical cannabinoid use in Germany.
• To identify patient subgroups that may particularly benefit or not benefit from cannabinoid therapies.
• To gather comprehensive data on ongoing cannabinoid treatments for improved future use.

Main Methods:

• A representative, anonymous, cross-sectional, web-based survey using mixed methods across 3 German federal states.
• Validated questionnaires assessed health conditions before and during cannabinoid therapy to estimate effect sizes.
• Cluster sampling via contracted physicians ensured representative recruitment of the hard-to-reach population.

Main Results:

• 256 participants were enrolled by June 2022.
• Validated questionnaires covered pain, spasticity, anorexia, multiple sclerosis, nausea, depression, and ADHD.
• Data included symptom scores, treatment satisfaction, quality of life, diagnoses, medication history, and sociodemographics.

Conclusions:

• The exploratory mixed-methods approach is expected to yield valid data for future clinical research.
• The study design aims for representativeness among outpatients treated with cannabinoids in the studied German states.
• The study may offer valuable insights beyond existing research, with limitations including its observational nature and inability to draw causal conclusions.