Clinical trial NCT05868213: Cannabis Observations on Brain Waves, Retrieval, and Attention: Experiment 1
Official title: ERP Studies of Acute Influences of THC and CBD on Memory Encoding and Retrieval Processes: Experiment 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cannabis
Memory
Electroencephalography
Keywords: Cannabis
Marijuana
Memory
Event-related potential
Electroencephalography
THC
CBD
Verbal learning
Episodic memory
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-22
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: This study investigates the impact of ∆9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on recognition memory in healthy, regular cannabis users. Participants complete the same recognition memory task after self-administering one of three different strains of cannabis flower one day and while not intoxicated another day. Event-related potentials (ERPs) are measured via electroencephalogram (EEG) during the recognition memory task. Blood is collected to quantify THC and CBD exposure. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Detailed description: Previous research has established cannabis's harmful cognitive impact, with particularly robust and consistent effects in the domain of verbal episodic memory. However, prior work has not sufficiently considered that the memory effects of cannabis are the compound action of different cannabinoids, which vary in their pharmacology and effects. Specifically, CBD, a non-psychotomimetic component of cannabis (doesn't produce a "high"), is thought to have cognitively protective properties and may mitigate some of the harmful effects of THC. Further, few prior studies have tested the effects of high potency strains that are commonly available.

This study tests the effects of commercially available cannabis flower strains on recognition memory performance and ERPs that are related to different underlying memory processes in healthy, regular cannabis users. An episodic memory task is used to assess recognition memory, which asks participants to discriminate between previously studied and non-studied items using words as stimuli. Participants complete the same memory task while intoxicated one day and not intoxicated another day. A THC-dominant, a CBD-dominant, and a strain containing both THC and CBD are included in the study. Participants self-administer one of the three cannabis strains prior to memory encoding and retrieval.

Blood is collected to determine THC and CBD exposure, as well as to explore how genetic variation in genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function associate with memory function before and after cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Eligibility criteria: Inclusion Criteria:

* Must be between the ages of 21 and 40 and provide informed consent.
* Must be right-handed (Laterality Quotient \> 60 on Edinburgh Handedness Inventory - Short Form).
* Must use cannabis at least 4 days during the month.
* Must be a cannabis user for at least a year.
* Must self-report not using other illicit recreational drugs (e.g., cocaine, benzodiazepines (non-prescription), opiates (non-prescription), MDMA, sedatives, or methamphetamine) in the past 30 days.
* Must not test positive on a urine toxicology test for drugs of abuse.
* Must not be using psychotropic medications, however anti-depressant, non-benzodiazepine anti-anxiety, and ADHD medications are ok. ADHD medication users must be willing to abstain from ADHD medication use on appointment days.
* Must not be a regular tobacco user (≤4 days per week; cigarette, E-cigs, or smokeless).
* Must not have used caffeine or tobacco (cigarette, E-cigs, or smokeless) for 4 hours prior to appointments.
* Must have a breath alcohol level of 0 to sign consent form.
* Must not be actively seeking or in treatment for any substance use disorder.
* Female subjects must not be or trying to become pregnant.
* Must not be in treatment for psychotic disorder or bipolar disorder; or have a history with these disorders.
* Must not have any physical characteristics (e.g., thick hair, head size exceeding the limit of the net, dyed hair) or experience any technical difficulties during testing that result in a poor-quality EEG recording.

Primary outcomes:
measure: Difference in ERP amplitude
timeFrame: intoxicated session and not-intoxicated session
measure: Difference in recognition memory performance
timeFrame: intoxicated session and not-intoxicated session (about 1 week)
Secondary outcomes:
measure: Difference in Flanker Task performance
timeFrame: intoxicated session and not-intoxicated session (about 1 week)
measure: Difference in Flanker Task ERPs
timeFrame: intoxicated session and not-intoxicated session (about 1 week)
measure: Change in Positive and Negative Affect Schedule (PANAS)
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Change in Drug Effects Questionnaire (DEQ)
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Change in Addiction Research Center Inventory (ARCI-M)
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Change in Marijuana Craving Questionnaire
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Change in Profile of Mood States (POMS)
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Change in Alcohol Craving Questionnaire
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Change in State Adapted Paranoia Checklist-Brief (SAPC-B)
timeFrame: before and after acute cannabis use (about 30 minutes)
measure: Difference in circulating cannabinoids
timeFrame: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
Other outcomes:
measure: Exploratory: Associations between genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function with ERPs and recognition memory performance
timeFrame: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
measure: Exploratory: Moderation of primary effects by baseline health and psychological functioning
timeFrame: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
Locations:
city: Boulder
country: United States
facility: Center for Innovation and Creativity
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Tim Curran, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Boulder
name: L. Cinnamon Bidwell, PhD
role: PRINCIPAL_INVESTIGATOR
References: