RECRUITING

Medical Cannabis and Behavior

Description

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.

Study Overview

Study Details

Study overview

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.

Neurobehavioral Impacts of Medical Cannabis Use: An Observational Study

Medical Cannabis and Behavior

Condition
Chronic Pain Patients
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Medical cannabis users (n=120) will be required to
  • 1. Be ages 35-65;
  • 2. 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.
  • 3. Have normal or corrected-to-normal vision and hearing;
  • 4. Be free of current and past DSM-V-defined substance use disorders; have \< 5 lifetime recreational uses of illicit drugs.
  • 5. Have limited daily exposure to nicotine (e.g., no daily smokers/vapers; use of nicotine products fewer than 5 occasions weekly);
  • 6. 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);
  • 7. Must be right handed as assessed by the Edinburgh Handedness Inventory;
  • 8. Lifetime use of cannabis \< 15 times; no cannabis product use (recreational or therapeutic) within the past six months;
  • 9. Able to schedule and complete a multi-hour single session protocol;
  • 10. Have sufficient manual mobility to be able to complete computerized neurocognitive assessments;
  • 11. Able to communicate with the researchers by phone during the four month pre-post assessment interval
  • 1. Be ages 35-65;
  • 2. Suffer from a chronic pain condition that could qualify them for medical cannabis; People with orthopedic pain will be prioritized.
  • 3. Have normal or corrected-to-normal vision and hearing;
  • 4. Be free of current and past DSM-V-defined substance use disorders; have \< 5 lifetime recreational uses of illicit drugs.
  • 5. Have limited daily exposure to nicotine (e.g., no daily smokers/vapers; use of nicotine products fewer than 5 occasions weekly);
  • 6. 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);
  • 7. Must be right handed as assessed by the Edinburgh Handedness Inventory;
  • 8. Lifetime use of cannabis \< 15 times; no cannabis product use (recreational or therapeutic) within the past six months;
  • 9. Able to schedule and complete a multi-hour single session protocol;
  • 10. Have sufficient manual mobility to be able to complete computerized neurocognitive assessments;
  • 11. 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.
  • 1. Cannot have a degenerative neurological condition or a neurological condition that impacts brain function (e.g., epilepsy);
  • 2. No contraindications to MRI scanning;
  • 3. No lifetime history of severe DSM-V psychopathology (psychotic disorders, bipolar disorder); if currently treated mood for anxiety disorders, must be stable;
  • 4. No current pregnancy or pregnancy within the prior 3 months; cannot be lactating;
  • 5. No cannabis product use (recreational or therapeutic) within the past six months;

Ages Eligible for Study

35 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Study Record Dates

2029-07-31