THC Memory & Reward Learning Pilot

NCT05116527 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HHC-2021-0195
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Tetrahydrocannabidiol (THC) is the psychoactive chemical in cannabis that makes people high. This study aims to dissect acute impairment of various forms of memory and learning by THC in cannabis compared to placebo. Impairment will be assessed via a short cognitive test battery and then subjects will complete four tasks in the fMRI scanner.

Conditions

Marijuana; THC; Cannabis

Keywords

Cannabis; THC; Marijuana; MRI; Memory; Learning

Outcome Measures

Primary Outcomes (4)

• Marijuana induced performance changes on fMRI Multi-Stage Decision Making (MSDM) Task.

  The MSDM is a reinforcement learning paradigm that quantifies the degree to which subjects can integrate recent trial-to-trial information about a stimulus' likelihood of reward with acquired knowledge about whether some choices generally lead to disadvantageous outcomes vs. others that more often lead to reward.

  Baseline and post drug administration at 10 minutes.

• Marijuana induced performance changes on Relational and Item Specific Coding (RISE) fMRI Task.

  The RISE task is a hippocampal-dependent learning paradigm that assesses declarative memory.

  Baseline and post drug administration at 10 minutes.

• Marijuana induced performance changes on fMRI Treadway/Effort Reward Task.

  The Treadway Effort/Reward Task independently measures the neural responses to two dimensions of a cost/benefit decision: the effort required and the magnitude of reward.

  Baseline and post drug administration at 10 minutes.

• Marijuana induced performance changes on fMRI Monetary Incentive Delay (MID) Task.

  The MID task probes the brain's reward system to assess the anticipation and receipt of rewards or punishment.

  Baseline and post drug administration at 10 minutes.

Study Arms (2)

High Dose THC

EXPERIMENTAL

Participants will receive high dose THC.

Drug: Marijuana, Hash, THC, or Grass

Placebo THC

EXPERIMENTAL

Participants will receive placebo THC.

Drug: Placebo

Interventions

Marijuana, Hash, THC, or Grass DRUG

Marijuana flower with a high THC content

Also known as: Marijuana, THC

High Dose THC

Placebo DRUG

Placebo THC - marijuana flower with no THC content

Placebo THC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Right handed
• CNB use within past 2 years and felt "high" when used
• Able to read, speak, and understand English
• Able and willing to provide written informed consent, and willing to commit to study protocol.

You may not qualify if:

• Current marijuana tolerance, desire to cut down, or cravings to sue during periods of abstinence.
• Strongly left-handed
• Positive screen for drug or alcohol (except CNB) on test day will result in rescheduling the appointment
• History of adverse effects with CNB
• CNB users who are abstaining
• Report of any psychotic disorder in a first degree relative
• IQ \< 80 on the Wechsler Abbreviated Scale of Intelligence
• Inability to comprehend written instructions using the WRAT-4 reading achievement test
• Pregnant, breastfeeding, and ineffective birth control methods.
• Unable or unsafe to have an MRI
• Serious medical, neuro-ophthalmological, or neurological illness (e.g. cancer, seizure disorders, encephalopathy
• History of head trauma with loss of consciousness \> 30 minutes or concussion lasting 30 days.
• Focal brain lesion seen on structural MRI
• Any medical/neurological condition that could compromise neurocognitive performance (e.g. epilepsy, multiple sclerosis, fetal alcohol syndrome).
• Anyone deemed unsafe to study personnel for any reason

Sponsors & Collaborators

• Hartford Hospital: lead
• Yale University: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Godfrey Pearlson, M.D

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: 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

Model Details: All subjects will receive both study drug and placebo.

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 11, 2021
• Study Start: July 7, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-04

Locations

US (1)