RECRUITING

Medical Cannabis and Behavior

Conditions

Chronic Pain Patients Medical Cannabis Users cannabis medical cannabis brain MRI pharmacokinetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Neurobehavioral Impacts of Medical Cannabis Use: An Observational Study

Quick Facts

Study Start:2025-06-18

Study Completion:2029-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06808048

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.

Ages Eligible for Study:35 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;

Inclusion Criteria

Exclusion 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;

Contacts and Locations

Study Contact

Monica Luciana, Ph.D.

CONTACT

612-626-0757

lucia003@umn.edu

Angela Birnbaum, Ph.D., MLS(ASCP), FAES

CONTACT

birnb002@umn.edu

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-18

Study Completion Date2029-07-31

Study Record Updates

Study Start Date2025-06-18

Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

cannabis
medical cannabis
brain MRI
pharmacokinetics

Additional Relevant MeSH Terms

Chronic Pain Patients
Medical Cannabis Users