Cannabis Observations on Brain Waves, Retrieval, and Attention: Experiment 1

Cannabis Clinical Trial

— COBRA  

Official title:

ERP Studies of Acute Influences of THC and CBD on Memory Encoding and Retrieval Processes: Experiment 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868213
• Other study ID #: 20-0309: Experiment 1
• Secondary ID: R01DA052431
• Status: Recruiting
• Start date: August 17, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2023
• Source: University of Colorado, Boulder
• Contact: Gregory R Giordano, MS
• Phone: 3034929549
• Email: cobra.custudy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis
• Electroencephalography
• Marijuana Abuse
• Memory

Intervention

Drug:
• Cannabis (smoked flower)
Self-Directed Use (ad-libitum)

Locations

Country	Name	City	State
United States	Center for Innovation and Creativity	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Boulder	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Associations between genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function with ERPs and recognition memory performance	DNA samples are collected from a baseline blood sample.	baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
Other	Exploratory: Moderation of primary effects by baseline health and psychological functioning	Baseline health and psychological function include measures of sleep quality, affective symptoms, and substance use history.	baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
Primary	Difference in ERP amplitude	Electroencephalography is used to quantify FN400 and parietal ERP effects.	intoxicated session and not-intoxicated session
Primary	Difference in recognition memory performance	Accuracy and reaction time will be used to assess task performance.	intoxicated session and not-intoxicated session (about 1 week)
Secondary	Difference in Flanker Task performance	Accuracy and reaction time will be used to assess task performance.	intoxicated session and not-intoxicated session (about 1 week)
Secondary	Difference in Flanker Task ERPs	Electroencephalography is used to quantify ERN effects.	intoxicated session and not-intoxicated session (about 1 week)
Secondary	Change in Positive and Negative Affect Schedule (PANAS)	The PANAS is Self-report measurement of positive and negative affect.	before and after acute cannabis use (about 30 minutes)
Secondary	Change in Drug Effects Questionnaire (DEQ)	The DEQ is a visual analogue scale of measure of acute drug effects.	before and after acute cannabis use (about 30 minutes)
Secondary	Change in Addiction Research Center Inventory (ARCI-M)	The ARCI-M is a self-report measure of subjective effects of marijuana.	before and after acute cannabis use (about 30 minutes)
Secondary	Change in Marijuana Craving Questionnaire	The Marijuana Craving Questionnaire is a self-report measure of marijuana craving.	before and after acute cannabis use (about 30 minutes)
Secondary	Change in Profile of Mood States (POMS)	The POMS is a self-report measure of mood.	before and after acute cannabis use (about 30 minutes)
Secondary	Change in Alcohol Craving Questionnaire	The Alcohol Craving Questionnaire is a self-report measure of alcohol craving.	before and after acute cannabis use (about 30 minutes)
Secondary	Change in State Adapted Paranoia Checklist-Brief (SAPC-B)	The SAPC-B is a self-report measure of paranoia.	before and after acute cannabis use (about 30 minutes)
Secondary	Difference in circulating cannabinoids	Blood levels of THC and CBD will be quantified.	baseline, intoxicated session, and not-intoxicated session (about 3 weeks)

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