Abstract
BackgroundThirty-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.MethodsThe 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.DiscussionThis 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.
Highlights
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
The study described in this protocol describes a strategy for unpacking the “black box” of variation in implementation of a single type of policy across multiple states
We use moderation analyses within a difference-in-differences framework to study whether specific policy implementation rules moderate laws’ effects on outcomes
Summary
Study aims and hypotheses Aim 1 Study aim 1 is to examine the effects of state medical cannabis laws on receipt of clinical guideline-discordant opioid and clinical guideline-concordant non-opioid, non-cannabis treatment among patients with chronic non-cancer pain. We expect state medical cannabis laws to reduce receipt of opioid and non-opioid, non-cannabis treatment among patients with low back pain, headache, fibromyalgia, arthritis, and/or neuropathic pain. Aim 2 Study aim 2 is to examine the effects of state medical cannabis laws on receipt of treatment for opioid use disorder, opioid overdose, cannabis use disorder, and cannabis poisoning among patients with chronic noncancer pain. We expect state medical cannabis laws to decrease utilization for opioid use disorder and opioid overdose and to increase utilization of treatment for cannabis use disorder and cannabis poisoning among patients with low back pain, headache, fibromyalgia, arthritis, and/or neuropathic pain. Aim 3 Study aim 3 is to characterize implementation of state medical cannabis laws for treatment of chronic noncancer pain. Hypotheses related to specific state medical cannabis policy implementation rules (aims 1–2) 1. Medicalization: Relative to less medicalized laws, laws with a higher degree of medicalization—shown to decrease medical cannabis program enrollment—will have a lesser effect on aim 1–2 outcomes
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