Medical Cannabis and Behavior

Conditions

• Chronic Pain Patients
• Medical Cannabis Users

Eligibility Criteria

Sex

ALL

Age

30 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Cognitive testing — BEHAVIORAL
  Participants will complete a cognitive testing battery that includes measures of attention, learning, memory, problem-solving and executive function.
• Task-based fMRI measure of face-name and verbal learning — BEHAVIORAL
  Cognitive testing Participants will complete a cognitive battery that includes measures of attention, learning, memory, and executive function. Behavioral: Task-based fMRI measure of face-name and verbal learning. These tasks will assess cannabis effects on explicit associative learning and memory mediated by frontohippocampal networks. Participants memorize face-name or word pairs (encoding), then recall the names and word pairs after a delay. The first encoding block begins with a "MEMORIZE" cue followed by 5 face-name or word pairs; participants press a button when each pair is encoded. A distractor block follows. Next, a retrieval block begins with a "RECALL" cue, followed by the same faces or words paired with a recall prompt, with a 4-second stimulus duration. On recall trials, participants indicate recall of the name for the displayed face or word stem and engage in silent uncued recall of learned pairs. After the scan, participants are tested for retrieval accuracy.

Study Details

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.

Key Dates

First listed

Feb 5, 2025

Start date

Jun 18, 2025

Status verified

Jul 2026

Primary completion

Jul 15, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

180 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• 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 memory. NIH considers the cognitive and fMRI tasks to be interventions. The fMRI learning and memory tasks measures face-name associative learning and verbal associative learning. 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.

Primary Outcome Measure

Rey Auditory Verbal Learning Test [ Time Frame: Administered at baseline and after four months ]

Central Contacts

• Monica Luciana, Ph.D.
  612-626-0757
  [email protected]
• Angela Birnbaum, Ph.D., MLS(ASCP), FAES
  [email protected]

Locations (1)

Find similar trials in Minneapolis, MN