Medical marijuana (MM) policies are changing rapidly, and the consequences of MM use for individuals who seek access to it are unknown. At the time of this submission, 25 states as well as the District of Columbia have legalized MM, and following this policy change, it is likely that individuals who either have not used marijuana in the past, or who have used marijuana occasionally for recreational purposes, will start to use marijuana medicinally for the first time. Once these individuals receive MM cards, they will have increased access to marijuana as well as societal permission because of perceived medical benefit. Increased access to marijuana may lead to escalation of use and possible marijuana-related harms; as recreational marijuana use has been associated with adverse heath outcomes such as cannabis use disorders (CUD), neurocognitive impairments, and brain-based changes, it is critical to study whether MM patients will experience similar effects. To address these timely and clinically important questions, we propose to conduct a randomized, longitudinal study of MM that will: (1) characterize the impact of MM on indices of addiction, such as CUD, escalation of use, tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the effect of MM use patterns on use of other medications, and perception of underlying disease symptomatology, (3) characterize the impact of MM on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of MM on brain structure and function. We propose to enroll 200 adults with no current CUD or heavy marijuana use (e.g. weekly or less frequent), who express interest in obtaining MM cards to use MM to treat pain, insomnia, anxiety, and/or depression, the most common conditions for which MM is used. Participants will be randomly assigned to either an active MM arm (n = 100) in which they can obtain MM cards without delay, or to a waitlist control arm (WLC) (n = 100), in which they are asked to wait 3 months before obtaining a card. Participants will be assessed at baseline, regularly for 3 months, and at a 6-month and 1-year follow-up for MM use behaviors, development of CUD, perception of disease symptomatology, and neurocognitive performance. Participants will be incentivized to keep detailed dosing diaries, via smartphone apps, to record how much MM was used each day, other medications used, and daily ratings of pain, sleep quality, and mood. Urine collected at each visit will be assessed with quantitative assays for cannabis metabolites. In the MM group, MRI scans will be collected at baseline and at 1 year, to longitudinally investigate possible brain changes associated with MM use. The proposed project will fill a critical gap in our knowledge, at a significant time when cannabis is being legalized for ?medical? use with little known about effects of MM on disease symptoms, addictions, neurocognition or brain function. We anticipate that the resulting data from this study will inform clinicians, scientists, and policy-makers about potential adverse effects of policy changes that increase access to MM.

Public Health Relevance

Medical marijuana (MM) policies are changing rapidly, and it is likely that individuals who either have not used marijuana in the past, or who use marijuana occasionally for recreational purposes, will start to use marijuana medically the first time. The proposed study will use a randomized controlled design to test whether patients who receive MM cards, compared to a waitlist control group, experience adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments, and brain-based changes. The resulting data will inform clinicians, scientists, and policy-makers about potential unforeseen effects of policy changes that increase access to MM.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
1R01DA042043-01A1
Application #
9309847
Study Section
Addiction Risks and Mechanisms Study Section (ARM)
Program Officer
Su, Shelley
Project Start
2017-04-01
Project End
2022-01-31
Budget Start
2017-04-01
Budget End
2018-01-31
Support Year
1
Fiscal Year
2017
Total Cost
$671,902
Indirect Cost
$278,977
Name
Massachusetts General Hospital
Department
Type
Independent Hospitals
DUNS #
073130411
City
Boston
State
MA
Country
United States
Zip Code
02114
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