THC + CBD and Memory Study
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ClinicalTrials.gov Identifier: NCT04855526 |
Recruitment Status : Unknown
Verified January 2022 by Godfrey Pearlson, Hartford Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 22, 2021
Last Update Posted : January 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Marijuana Use Cannabis Use Cannabis Intoxication | Drug: High THC/No CBD Marihuana Drug: High THC/High CBD Marihuana Drug: No THC/No CBD Marihuana | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Effects of Marijuana on Memory-Related Neurochemistry and Neural Response |
Estimated Study Start Date : | April 1, 2022 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | June 30, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Occasional Users - High THC and High CBD Dose
People who smoke marijuana occasionally will be given a dose of high THC high CBD marijuana at the study visit
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Drug: High THC/High CBD Marihuana
high THC (65 mg THC) and high CBD (50 mg CBD) |
Experimental: Occasional Users - High THC and No CBD Dose
People who smoke marijuana occasionally will be given a dose of high THC and no CBD marijuana at the study visit
|
Drug: High THC/No CBD Marihuana
high THC (65 mg THC) and no CBD (0 mg CBD) |
Experimental: Occasional Users - No THC and No CBD Dose
People who smoke marijuana occasionally will be given a dose of marijuana that contains no THC or CBD
|
Drug: No THC/No CBD Marihuana
no THC (0 mg THC) and no CBD (0 mg CBD); placebo drug |
- fMRI response [ Time Frame: approximately 1 hour following drug administration ]Blood oxygen level dependent functional magnetic resonance imaging (fMRI) response during the relational and item specific encoding task. fMRI response will be evaluated during the encoding phase (relational vs. item encoding), item recognition phase (hits vs. misses for item-specific encoding, and hits vs. misses for relational encoding), and associative recognition phase (hits vs. misses).
- Glutamate [ Time Frame: approximately 1 hour following drug administration ]Magnetic resonance spectroscopy (MRS)-acquired glutamate containing compounds (Glx).
- HVLT-R performance [ Time Frame: Approximately 2.50 hours after drug administration ]The Hopkins Verbal Learning Test-Revised will ascertain verbal list learning and immediate and delayed recall (~15min); alternate forms have been validated, and the order of versions participants receive will be randomized
- Performance on CHARLIE cognitive task [ Time Frame: Approximately 3.00 hours after drug administration ]This is a computer-based cognitive battery that administers the Digit Span and Letter/Number Sequencing Test (working memory) and the Digit Symbol Coding test (processing speed). It should take about 10 minutes to complete.
- Blood THC and CBD concentration testing [ Time Frame: Immediately after drug administration (~0.25 hours after drug administration) ]A blood sample will be taken once per dose visit to assess the concentration of the following metabolites in ng/mL: delta-9-tetrahydrocannabinol, 11-hydroxy-tetrahydrocannabinol, 11-Nor-9-Carboxy-tetrahydrocannabinol (THCCOOH), tetrahydrocannabinol-Glucuronide, THCCOOH-Glucuronide, cannabinol (CBN), and cannabidiol (CBD).
- Subjective effects on drug effects questionnaire [ Time Frame: Post drug administration at: 0.00 hours (immediately after); 1.0 hours; 2.0 hours; 3.0 hours ]This self-report will be used to assess subjective reports every 60 minutes throughout the dose visit days. These subjective ratings will be obtained using rapidly completed Visual Analog Scales (VASs) scored on a 0-100 scale. Items include: Do you feel a drug effect right now?, Are you high right now?, Do you dislike any of the effects you are feeling right now?, Do you like any of the effects you are feeling right now? and Would you like more of the drug you took, right now?
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Right-handed
- Prior MJ users (has used MJ at least once in the past year, but no more than 1x/month in the past 12 months)
- Medically healthy (as determined by medical history and treatment)
- Adequate comprehension of English in order to complete study materials
- Acceptable birth control method for women (i.e., no copper IUD or any device that is not MRI safe)
Exclusion Criteria:
- Participant currently uses psychoactive medications or substances
- Psychiatric diagnoses (determined by DSM-V)
- Participant heavily or regularly uses MJ (more than 1x/month in the past year)
- Current or past substance dependence (including MJ)
- Positive urine toxicology screens
- Positive pregnancy screens
- MRI contraindications (e.g., heart pacemaker)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855526
Contact: Chelsea N Meagher, BA | 860-545-7106 | chelsea.meagher@hhchealth.org | |
Contact: Diana G King, BA | 860-545-7563 | diana.king@hhchealth.org |
Principal Investigator: | Godfrey Pearlson, MD | Hartford Hospital - Olin Neuropsychiatry Research Center; Yale University | |
Principal Investigator: | Alecia Dager, PhD | Hartford Hospital - Olin Neuropsychiatry Research Center; Yale University | |
Principal Investigator: | Michael Stevens, PhD | Hartford Hospital - Olin Neuropsychiatry Research Center |
Responsible Party: | Godfrey Pearlson, Founding Director Olin Neuropsychiatry Research Center; Professor Yale University, Hartford Hospital |
ClinicalTrials.gov Identifier: | NCT04855526 |
Other Study ID Numbers: |
R-HHC-2019-0137 126663 ( Other Grant/Funding Number: Hartford Hospital ) |
First Posted: | April 22, 2021 Key Record Dates |
Last Update Posted: | January 6, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
marijuana cannabidiol memory THC cannabis |
intoxication MRI glutamate MRS |
Marijuana Abuse Marijuana Use Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Dronabinol Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |