NCT04855526

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for early_phase_1

Timeline
6mo left

Started Dec 2025

Shorter than P25 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Dec 2025Dec 2026

First Submitted

Initial submission to the registry

April 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
4.6 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

April 19, 2021

Last Update Submit

March 13, 2025

Conditions

Keywords

marijuanacannabidiolmemoryTHCcannabisintoxicationMRIglutamateMRS

Outcome Measures

Primary Outcomes (2)

  • 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).

    approximately 1 hour following drug administration

  • Glutamate

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

    approximately 1 hour following drug administration

Secondary Outcomes (4)

  • HVLT-R performance

    Approximately 2.50 hours after drug administration

  • Performance on CHARLIE cognitive task

    Approximately 3.00 hours after drug administration

  • Blood THC and CBD concentration testing

    Immediately after drug administration (~0.25 hours after drug administration)

  • Subjective effects on drug effects questionnaire

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

Study Arms (3)

Occasional Users - High THC and High CBD Dose

EXPERIMENTAL

People who smoke marijuana occasionally will be given a dose of high THC high CBD marijuana at the study visit

Drug: High THC/High CBD Marihuana

Occasional Users - High THC and No CBD Dose

EXPERIMENTAL

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

Occasional Users - No THC and No CBD Dose

EXPERIMENTAL

People who smoke marijuana occasionally will be given a dose of marijuana that contains no THC or CBD

Drug: No THC/No CBD Marihuana

Interventions

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

Occasional Users - High THC and No CBD Dose

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

Occasional Users - High THC and High CBD Dose

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

Occasional Users - No THC and No CBD Dose

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana UseMarijuana Abuse

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founding Director Olin Neuropsychiatry Research Center; Professor Yale University

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 22, 2021

Study Start

December 1, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share