CannabisCOBRANCT05868213
Cannabis Observations on Brain Waves, Retrieval, and Attention: Experiment 1
An observational study of Cannabis and Memory, run by University of Colorado, Boulder at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Memory, Electroencephalography
- What is being tested?
- Cannabis (smoked flower)
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community Sample
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Innovation and Creativity
Boulder, Colorado, 80301
About this study
Official title: ERP Studies of Acute Influences of THC and CBD on Memory Encoding and Retrieval Processes: 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.
Read the 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.
- Conditions
- Cannabis, Memory, Electroencephalography
- Being tested
- Cannabis (smoked flower)
- Keywords
- Cannabis, Marijuana, Memory, Event-related potential, Electroencephalography, THC, CBD, Verbal learning, Episodic memory
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis (smoked flower)Drug
Self-Directed Use (ad-libitum)
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in ERP amplitude
Electroencephalography is used to quantify FN400 and parietal ERP effects.
Measured: intoxicated session and not-intoxicated session
Difference in recognition memory performance
Accuracy and reaction time will be used to assess task performance.
Measured: intoxicated session and not-intoxicated session (about 1 week)
Secondary outcomes (10)
Difference in Flanker Task performance
Accuracy and reaction time will be used to assess task performance.
Measured: intoxicated session and not-intoxicated session (about 1 week)
Difference in Flanker Task ERPs
Electroencephalography is used to quantify ERN effects.
Measured: intoxicated session and not-intoxicated session (about 1 week)
Change in Positive and Negative Affect Schedule (PANAS)
The PANAS is Self-report measurement of positive and negative affect.
Measured: before and after acute cannabis use (about 30 minutes)
Change in Drug Effects Questionnaire (DEQ)
The DEQ is a visual analogue scale of measure of acute drug effects.
Measured: before and after acute cannabis use (about 30 minutes)
Change in Addiction Research Center Inventory (ARCI-M)
The ARCI-M is a self-report measure of subjective effects of marijuana.
Measured: before and after acute cannabis use (about 30 minutes)
Change in Marijuana Craving Questionnaire
The Marijuana Craving Questionnaire is a self-report measure of marijuana craving.
Measured: before and after acute cannabis use (about 30 minutes)
Change in Profile of Mood States (POMS)
The POMS is a self-report measure of mood.
Measured: before and after acute cannabis use (about 30 minutes)
Change in Alcohol Craving Questionnaire
The Alcohol Craving Questionnaire is a self-report measure of alcohol craving.
Measured: before and after acute cannabis use (about 30 minutes)
Change in State Adapted Paranoia Checklist-Brief (SAPC-B)
The SAPC-B is a self-report measure of paranoia.
Measured: before and after acute cannabis use (about 30 minutes)
Difference in circulating cannabinoids
Blood levels of THC and CBD will be quantified.
Measured: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start17 Aug 2022
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, L. Cinnamon Bidwell, University of Colorado, Boulder
- Investigators
- Tim Curran, PhD, Principal investigator, University of Colorado, BoulderL. Cinnamon Bidwell, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868213
- Sponsor's protocol ID
- 20-0309: Experiment 1
- Other IDs
- R01DA052431
- Acronym
- COBRA
- Status last verified
- Dec 2024
- First submitted
- 11 Apr 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERP Studies of Acute Influences of THC and CBD on Memory Encoding and Retrieval Processes: Experiment 1
- ClinicalTrials.gov ID
- NCT05868213
- Acronym / sponsor ID
- COBRA / 20-0309: Experiment 1
- Conditions
- Cannabis, Memory, Electroencephalography
- Keywords
- Cannabis, Marijuana, Memory, Event-related potential, Electroencephalography, THC, CBD, Verbal learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community Sample
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis (smoked flower)Self-Directed Use (ad-libitum) | Drug | – |
Primary outcome
Difference in ERP amplitude
Time frame: intoxicated session and not-intoxicated session
Electroencephalography is used to quantify FN400 and parietal ERP effects.
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.
10 secondary outcomes
Difference in Flanker Task performance
Time frame: intoxicated session and not-intoxicated session (about 1 week)
Difference in Flanker Task ERPs
Time frame: intoxicated session and not-intoxicated session (about 1 week)
Change in Positive and Negative Affect Schedule (PANAS)
Time frame: before and after acute cannabis use (about 30 minutes)
Change in Drug Effects Questionnaire (DEQ)
Time frame: before and after acute cannabis use (about 30 minutes)
Change in Addiction Research Center Inventory (ARCI-M)
Time frame: before and after acute cannabis use (about 30 minutes)
Change in Marijuana Craving Questionnaire
Time frame: before and after acute cannabis use (about 30 minutes)
Change in Profile of Mood States (POMS)
Time frame: before and after acute cannabis use (about 30 minutes)
Change in Alcohol Craving Questionnaire
Time frame: before and after acute cannabis use (about 30 minutes)
Change in State Adapted Paranoia Checklist-Brief (SAPC-B)
Time frame: before and after acute cannabis use (about 30 minutes)
Difference in circulating cannabinoids
Time frame: baseline, intoxicated session, and not-intoxicated session (about 3 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- More informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Curran, PhD principal investigator
University of Colorado, Boulder
L. Cinnamon Bidwell, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis and Memory, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in ERP amplitude (time frame: intoxicated session and not-intoxicated session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.