Actively Recruiting
Neurobehavioral Impacts of Medical Cannabis Use in Adults with Chronic Pain: An Observational Study
Led by University of Minnesota · Updated on 2025-06-29
180
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how medical cannabis affects cognition, brain function, and drug exposure in adults with chronic pain aged 35 to 65. The study compares outcomes for patients using CBD-dominant versus THC-dominant cannabis products. It aims to understand whether medical cannabis leads to cognitive changes, affects brain structure and activity, and how these outcomes relate to age and blood levels of cannabinoids. This observational study will also compare medical cannabis users to matched pain patients who do not use cannabis to fill a gap in current research on medical cannabis effects in adults. Participants will complete baseline assessments before starting medical cannabis treatment and then continue with monthly interviews to track treatment adherence, pain, quality of life, and substance use over four months. Cognitive testing and brain MRI scans will be performed at the start and after four months to evaluate attention, memory, learning, executive function, and brain connectivity. Behavioral tasks during fMRI scans will assess learning and inhibitory control, and blood samples will measure cannabinoid levels. Both medical cannabis users and non-users will be included to allow comparison. Throughout the study, participants will complete daily medication diaries and undergo multiple cognitive and fMRI sessions. Researchers will assess various cognitive tests and brain imaging measures at baseline and after treatment. Monthly phone interviews will monitor substance use and mood. The study will analyze how treatment impacts cognition, brain function, and risk for cannabis use disorder, with safety monitoring through breathalyzer and urine tests. Total participation lasts about four months with comprehensive assessments before and after this period.
CONDITIONS
Brief Title
Medical Cannabis and Behavior
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 35 to 65 years
- Qualified for medical cannabis treatment based on chronic pain diagnosis, prioritizing orthopedic pain
- Normal or corrected vision and hearing
- No current or past substance use disorders; fewer than 5 lifetime recreational illicit drug uses
- Limited nicotine use (fewer than 5 occasions weekly; no daily smokers or vapers)
- Willing to abstain from alcohol, nicotine, and non-treatment drugs for 24 hours before testing, verified by breathalyzer and urine test
- Right-handed as determined by the Edinburgh Handedness Inventory
- Lifetime cannabis use fewer than 15 times; no cannabis use in past 6 months
- Able to complete multi-hour cognitive testing sessions
- Sufficient manual ability for computerized assessments
- Able to communicate by phone during the four-month study period
- No plans to relocate during the four-month study period
You will not qualify if you...
- Degenerative or neurological conditions affecting brain function (e.g., epilepsy)
- Contraindications to MRI scanning
- Severe psychiatric conditions like psychotic disorders or bipolar disorder; mood or anxiety disorders must be stable if treated
- Current pregnancy, pregnancy within past 3 months, or lactation
- Cannabis use (recreational or therapeutic) within past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete comprehensive cognitive testing, task-based fMRI scans, blood cannabinoid level measurements, and clinical interviews before starting medical cannabis treatment.
1 baseline visit (in-person)
Duration - 4 months
Participants start medical cannabis treatment and are monitored monthly by phone for treatment adherence, pain levels, quality of life, and substance use. They also keep a daily medication diary throughout the study.
Monthly phone calls and daily medication diary
Duration - 1 day
Participants repeat cognitive testing, task-based fMRI scans, blood cannabinoid measurements, and clinical interviews after four months of treatment to assess changes in neurobehavioral function.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
M
Monica Luciana, Ph.D.
A
Angela Birnbaum, Ph.D., MLS(ASCP), FAES
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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