Neurobehavioral Impacts of Medical Cannabis Use: An Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will assess cognition, neural function, and drug exposure in chronic pain patients who have been prescribed medical cannabis and will differentiate outcomes based on use of specific CBD-dominant versus THC-dominant treatment products. This longitudinal study will recruit medical cannabis users from local dispensaries. Each participant will complete a baseline assessment prior to the start of medical cannabis use, monthly phone calls to assess treatment adherence, and a four-month follow- up assessment. The aims of this project are: Aim 1. To assess impacts of medical cannabis compounds on executive functions, learning and memory in adults to determine whether cognitive impairments are evident after the onset of cannabis use; Aim 2. To assess the impacts of medical cannabis compounds on white matter microstructure, functional brain activity and functional connectivity; Aim 3. To differentiate change over four months in these outcomes as a function of (a) age and (b) pre-to-post-treatment changes in blood levels of cannabinoid compounds.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
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• Medical cannabis users (n=120) will be required to

∙ Be ages 35-65;

‣ Be qualified for a medical cannabis prescription based only on a diagnosis of chronic pain; note that individuals can, in theory, utilize medical cannabis for more than one qualifying condition. People with orthopedic pain will be prioritized.

‣ Have normal or corrected-to-normal vision and hearing;

‣ Be free of current and past DSM-V-defined substance use disorders; have \< 5 lifetime recreational uses of illicit drugs.

‣ Have limited daily exposure to nicotine (e.g., no daily smokers/vapers; use of nicotine products fewer than 5 occasions weekly);

‣ Willing to abstain from alcohol, nicotine, and other (non-treatment) drugs for 24 hours prior to study. Abstinence will be verified by breathalyzer and urine drug screening; must not test positive on breathalyzer and urine drug screenings for any nonprescribed psychoactive substance or for cannabis (at baseline);

‣ Must be right handed as assessed by the Edinburgh Handedness Inventory;

‣ Lifetime use of cannabis \< 15 times; no cannabis product use (recreational or therapeutic) within the past six months;

‣ Able to schedule and complete a multi-hour single session protocol;

∙ Have sufficient manual mobility to be able to complete computerized neurocognitive assessments;

∙ Able to communicate with the researchers by phone during the four month pre-post assessment interval

• Pain patients who are not using medical cannabis (n=60) will be required to:

⁃ Be ages 35-65;

⁃ Suffer from a chronic pain condition that could qualify them for medical cannabis; People with orthopedic pain will be prioritized.

⁃ Have normal or corrected-to-normal vision and hearing;

⁃ Be free of current and past DSM-V-defined substance use disorders; have \< 5 lifetime recreational uses of illicit drugs.

⁃ Have limited daily exposure to nicotine (e.g., no daily smokers/vapers; use of nicotine products fewer than 5 occasions weekly);

⁃ Willing to abstain from alcohol, nicotine, and other (non-treatment) drugs for 24 hours prior to study. Abstinence will be verified by breathalyzer and urine drug screening; must not test positive on breathalyzer and urine drug screenings for any non- prescribed psychoactive substance or for cannabis (at baseline);

⁃ Must be right handed as assessed by the Edinburgh Handedness Inventory;

⁃ Lifetime use of cannabis \< 15 times; no cannabis product use (recreational or therapeutic) within the past six months;

⁃ Able to schedule and complete a multi-hour single session protocol;

‣ Have sufficient manual mobility to be able to complete computerized neurocognitive assessments;

‣ Able to communicate with the researchers by phone during the four month pre-post assessment interval Within both groups, concomitant opioid use will be allowed as will other prescribed treatments. Controls will be matched to the cannabis group on age, sex, socioeconomic status (SES), type of pain condition (orthopedic pain will be targeted) and comorbid opioid use.

• All potential participants must indicate at the baseline enrollment that they have no immediate plans to relocate from the Twin Cities metro area (e.g., must be willing and able to participate in longitudinal assessment for a four-month period).

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Monica Luciana, Ph.D.
lucia003@umn.edu
612-626-0757
Backup
Angela Birnbaum, Ph.D., MLS(ASCP), FAES
birnb002@umn.edu
Time Frame
Start Date: 2025-06-18
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 180
Treatments
Experimental: Experimental cognitive and fMRI-based tasks
One primary aim of this study is to examine cognitive functioning in individuals who use medical cannabis. All participants in the study will complete cognitive measures that include measures of attention, learning, memory and executive function. All participants will complete task fMRI-based measures of learning and inhibitory control. NIH considers the cognitive and fMRI tasks to be interventions. The fMRI learning task measures face-name associative learning. The fMRI inhibitory control task is a go/no-go task whereby participants respond on some trials to go stimuli and withhold responses on other trials to no-go stimuli. Brain activations are measured in response to each task. Each participant will complete two cognitive testing sessions as well as two fMRI sessions during the course of the study.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov