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Search / Trial NCT06808048

Medical Cannabis and Behavior

Launched by UNIVERSITY OF MINNESOTA · Jan 28, 2025

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Cannabis Medical Cannabis Brain Mri Pharmacokinetics

ClinConnect Summary

This clinical trial is looking to understand how medical cannabis affects the brain and behavior in patients dealing with chronic pain. Specifically, the study will compare the impacts of two types of cannabis products: those high in CBD (a non-psychoactive compound) and those high in THC (the compound that causes a "high"). Researchers will evaluate how these products affect thinking abilities, memory, and brain function over a four-month period. Participants will be recruited from local dispensaries and will undergo assessments before starting cannabis, monthly check-ins to see how they're doing, and a final evaluation after four months.

To be eligible for this study, participants must be between the ages of 35 and 65, suffering from chronic pain, and currently using medical cannabis or eligible to use it. They should also have no serious substance use issues, limited nicotine use, and must be right-handed. Participants will need to avoid alcohol and other drugs before tests. This study is an opportunity to help researchers learn more about how medical cannabis might affect cognition and brain health, which could lead to better treatment options for chronic pain in the future.

Gender

ALL

Eligibility criteria

  • Inclusion 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
  • Pain patients who are not using medical cannabis (n=60) will be required to:
  • 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.
  • 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).
  • Exclusion Criteria:
  • 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;

About University Of Minnesota

The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.

Locations

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported