Health TrialsbyHealthPanel

THC + CBD and Memory Study

ConditionsMarijuana UseCannabis UseCannabis Intoxication
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorHartford Hospital

About this trial

Memory deficits are one of the most consistently observed cognitive effects of marijuana use. There is evidence that some decrements attributable to the primary psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will help us learn more about the relationship between THC and CBD consumption with memory processes. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC and CBD use.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • High THC/No CBD Marihuana

    Drug

    high THC (65 mg THC) and no CBD (0 mg CBD)

  • High THC/High CBD Marihuana

    Drug

    high THC (65 mg THC) and high CBD (50 mg CBD)

  • No THC/No CBD Marihuana

    Drug

    no THC (0 mg THC) and no CBD (0 mg CBD); placebo drug

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: Occasional Users - High THC and High CBD DoseExperimental treatment 1 intervention
Group B: Occasional Users - High THC and No CBD DoseExperimental treatment 1 intervention
Group C: Occasional Users - No THC and No CBD DoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

fMRI response

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).

Time frame
approximately 1 hour following drug administration
2

Glutamate

Magnetic resonance spectroscopy (MRS)-acquired glutamate containing compounds (Glx).

Time frame
approximately 1 hour following drug administration

Secondary outcomes

1

HVLT-R performance

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

Time frame
Approximately 2.50 hours after drug administration
2

Performance on CHARLIE cognitive task

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.

Time frame
Approximately 3.00 hours after drug administration
3

Blood THC and CBD concentration testing

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).

Time frame
Immediately after drug administration (~0.25 hours after drug administration)
4

Subjective effects on drug effects questionnaire

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?

Time frame
Post drug administration at: 0.00 hours (immediately after); 1.0 hours; 2.0 hours; 3.0 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hartford Hospital

Lead sponsor

Yale University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: