Protocol: Mixed-methods Study of How Implementation of US State Medical Cannabis Laws Affects Treatment of Chronic Non-cancer Pain and Adverse Opioid Outcomes

Background: Thirty-three US states and Washington, D.C., have enacted medical cannabis laws allowing patients with chronic non-cancer pain to use cannabis, when recommended by a physician, to manage their condition. However, clinical guidelines do not recommend cannabis for treatment of chronic non-cancer pain due to limited and mixed evidence of effectiveness. How state medical cannabis laws affect delivery of evidence-based treatment for chronic non-cancer pain is unclear. These laws could lead to substitution of cannabis in place of clinical guideline-discordant opioid prescribing, reducing risk of opioid use disorder and overdose. Conversely, state medical cannabis laws could lead to substitution of cannabis in place of guideline-concordant treatments such as topical analgesics or physical therapy. This protocol describes a mixed-methods study examining the implementation and effects of state medical cannabis laws on treatment of chronic non-cancer pain. A key contribution of the study is the examination of how variation in state medical cannabis laws' policy implementation rules affects receipt of chronic non-cancer pain treatments.

Methods: The study uses a concurrent-embedded design. The primary quantitative component of the study employs a difference-in-differences design using a policy trial emulation approach. Quantitative analyses will evaluate state medical cannabis laws' effects on treatment for chronic non-cancer pain as well as on receipt of treatment for opioid use disorder, opioid overdose, cannabis use disorder, and cannabis poisoning among people with chronic non-cancer pain. Secondary qualitative and survey methods will be used to characterize implementation of state medical cannabis laws through interviews with state leaders and representative surveys of physicians who treat, and patients who experience, chronic non-cancer pain in states with medical cannabis laws.

Discussion: This study will examine the effects of medical cannabis laws on patients' receipt of guideline-concordant non-opioid, non-cannabis treatments for chronic non-cancer pain and generate new evidence on the effects of state medical cannabis laws on adverse opioid outcomes. Results will inform the dynamic policy environment in which numerous states consider, enact, and/or amend medical cannabis laws each year.