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

Sponsor

University of Colorado, Boulder (Other)

Overall Status

Recruiting

CT.gov ID

NCT05868213

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

40.5

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cannabis Memory Electroencephalography	Drug: Cannabis (smoked flower)

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 17, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

Difference in ERP amplitude [intoxicated session and not-intoxicated session]
Electroencephalography is used to quantify FN400 and parietal ERP effects.
Difference in recognition memory performance [intoxicated session and not-intoxicated session (about 1 week)]
Accuracy and reaction time will be used to assess task performance.

Secondary Outcome Measures

Difference in Flanker Task performance [intoxicated session and not-intoxicated session (about 1 week)]
Accuracy and reaction time will be used to assess task performance.
Difference in Flanker Task ERPs [intoxicated session and not-intoxicated session (about 1 week)]
Electroencephalography is used to quantify ERN effects.
Change in Positive and Negative Affect Schedule (PANAS) [before and after acute cannabis use (about 30 minutes)]
The PANAS is Self-report measurement of positive and negative affect.
Change in Drug Effects Questionnaire (DEQ) [before and after acute cannabis use (about 30 minutes)]
The DEQ is a visual analogue scale of measure of acute drug effects.
Change in Addiction Research Center Inventory (ARCI-M) [before and after acute cannabis use (about 30 minutes)]
The ARCI-M is a self-report measure of subjective effects of marijuana.
Change in Marijuana Craving Questionnaire [before and after acute cannabis use (about 30 minutes)]
The Marijuana Craving Questionnaire is a self-report measure of marijuana craving.
Change in Profile of Mood States (POMS) [before and after acute cannabis use (about 30 minutes)]
The POMS is a self-report measure of mood.
Change in Alcohol Craving Questionnaire [before and after acute cannabis use (about 30 minutes)]
The Alcohol Craving Questionnaire is a self-report measure of alcohol craving.
Change in State Adapted Paranoia Checklist-Brief (SAPC-B) [before and after acute cannabis use (about 30 minutes)]
The SAPC-B is a self-report measure of paranoia.
Difference in circulating cannabinoids [baseline, intoxicated session, and not-intoxicated session (about 3 weeks)]
Blood levels of THC and CBD will be quantified.

Other Outcome Measures

Exploratory: Associations between genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function with ERPs and recognition memory performance [baseline, intoxicated session, and not-intoxicated session (about 3 weeks)]
DNA samples are collected from a baseline blood sample.
Exploratory: Moderation of primary effects by baseline health and psychological functioning [baseline, intoxicated session, and not-intoxicated session (about 3 weeks)]
Baseline health and psychological function include measures of sleep quality, affective symptoms, and substance use history.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Innovation and Creativity	Boulder	Colorado	United States	80301

Sponsors and Collaborators

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

Investigators

Principal Investigator: Tim Curran, PhD, University of Colorado, Boulder
Principal Investigator: L. Cinnamon Bidwell, PhD, University of Colorado, Boulder