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Completed

NCT Number: NCT05868213

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

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.

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Innovation and Creativity

Boulder, Colorado, 80301, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabis (smoked flower)

Drug

Self-Directed Use (ad-libitum)

Primary outcomes

  1. Difference in ERP amplitude

    Time frame: intoxicated session and not-intoxicated session

    Electroencephalography is used to quantify FN400 and parietal ERP effects.

  2. Difference in recognition memory performance

    Time frame: intoxicated session and not-intoxicated session (about 1 week)

    Accuracy and reaction time will be used to assess task performance.

Secondary outcomes

  1. Difference in Flanker Task performance

    Time frame: intoxicated session and not-intoxicated session (about 1 week)

    Accuracy and reaction time will be used to assess task performance.

  2. Difference in Flanker Task ERPs

    Time frame: intoxicated session and not-intoxicated session (about 1 week)

    Electroencephalography is used to quantify ERN effects.

  3. Change in Positive and Negative Affect Schedule (PANAS)

    Time frame: before and after acute cannabis use (about 30 minutes)

    The PANAS is Self-report measurement of positive and negative affect.

  4. Change in Drug Effects Questionnaire (DEQ)

    Time frame: before and after acute cannabis use (about 30 minutes)

    The DEQ is a visual analogue scale of measure of acute drug effects.

  5. Change in Addiction Research Center Inventory (ARCI-M)

    Time frame: before and after acute cannabis use (about 30 minutes)

    The ARCI-M is a self-report measure of subjective effects of marijuana.

  6. Change in Marijuana Craving Questionnaire

    Time frame: before and after acute cannabis use (about 30 minutes)

    The Marijuana Craving Questionnaire is a self-report measure of marijuana craving.

  7. Change in Profile of Mood States (POMS)

    Time frame: before and after acute cannabis use (about 30 minutes)

    The POMS is a self-report measure of mood.

  8. Change in Alcohol Craving Questionnaire

    Time frame: before and after acute cannabis use (about 30 minutes)

    The Alcohol Craving Questionnaire is a self-report measure of alcohol craving.

  9. Change in State Adapted Paranoia Checklist-Brief (SAPC-B)

    Time frame: before and after acute cannabis use (about 30 minutes)

    The SAPC-B is a self-report measure of paranoia.

  10. Difference in circulating cannabinoids

    Time frame: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)

    Blood levels of THC and CBD will be quantified.

Other outcomes

  1. Exploratory: Associations between genes related to cannabinoid metabolism, cannabis-related behavior, and neurocognitive function with ERPs and recognition memory performance

    Time frame: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)

    DNA samples are collected from a baseline blood sample.

  2. Exploratory: Moderation of primary effects by baseline health and psychological functioning

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: COBRA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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