Actively Recruiting

Phase Not Applicable
Age: 35Years - 65Years
All Genders
NCT06808048

Medical Cannabis and Behavior

Led by University of Minnesota · Updated on 2025-06-29

180

Participants Needed

1

Research Sites

214 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

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.

CONDITIONS

Official Title

Medical Cannabis and Behavior

Who Can Participate

Age: 35Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 35 and 65 years old
  • Have a diagnosis of chronic pain qualifying for medical cannabis treatment; priority given to orthopedic pain
  • Have normal or corrected vision and hearing
  • No current or past substance use disorders; fewer than 5 lifetime recreational uses of illicit drugs
  • Limited daily nicotine exposure; no daily smokers or vapers; nicotine use fewer than 5 times per week
  • Willing to abstain from alcohol, nicotine, and non-treatment drugs for 24 hours prior to study visits; abstinence verified by breathalyzer and urine tests
  • Right-handed as assessed by the Edinburgh Handedness Inventory
  • Lifetime cannabis use fewer than 15 times; no cannabis use in past six months
  • Able to schedule and complete a multi-hour single session protocol
  • Have sufficient manual mobility for computerized cognitive assessments
  • Able to communicate by phone during the four-month study period
  • No immediate plans to relocate from the Twin Cities metro area, ensuring availability for follow-up
Not Eligible

You will not qualify if you...

  • Have degenerative neurological conditions or conditions affecting brain function (e.g., epilepsy)
  • Have contraindications to MRI scanning
  • Have a history of severe psychiatric disorders such as psychosis or bipolar disorder; stable mood or anxiety disorder treatment allowed
  • Are currently pregnant, have been pregnant in the past 3 months, or are lactating
  • Have used cannabis products recreationally or therapeutically within the past six months

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

M

Monica Luciana, Ph.D.

CONTACT

A

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

CONTACT

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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