Cannabinoids for Memory Function

(THC-Memory Trial)

Overseen By Christina Luddy, BS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Disqualifiers: Cannabis naive, Pregnancy, Hearing deficits

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

80 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is the drug THC effective for improving memory function?

Research suggests that THC, a component of cannabis, generally impairs memory function rather than improving it. Studies in animals and humans have shown that THC can decrease memory accuracy and disrupt memory processes. ^{1 2 3 4 5}

Is the use of cannabinoids generally safe for humans?

Cannabinoids, including THC, have been studied for safety in various contexts. A study on medical cannabis for chronic pain found no increased risk of serious side effects, though mild to moderate non-serious side effects were more common. The European Food Safety Authority has set guidelines for safe THC intake levels, and while cannabinoids can have adverse effects, they are generally considered safe when used appropriately under medical supervision. ^{6 7 8 9 10}

How does the drug THC differ from other treatments for memory function?

THC (Tetrahydrocannabinol) is unique in its ability to impair memory by acting on the CB1 receptors in the brain, which are involved in memory processes. Unlike other treatments, THC's effects on memory can be influenced by the presence of CBD (Cannabidiol), which may counteract THC's memory-impairing effects. ^{2 3 4 5 11}

What is the purpose of this trial?

The overarching goal of this study is to characterize the effects of cannabinoids on working and episodic memory.

Research Team

Mohini Ranganathan, M.D.

Principal Investigator

Assistant Professor

Eligibility Criteria

This trial is for men and women aged between 18 and 55 who have used cannabis at least once. It's not suitable for those with hearing deficits, individuals who've never used cannabis, or women with a positive pregnancy test.

Inclusion Criteria

Exposed to cannabis at least once in their lifetime

Exclusion Criteria

Cannabis naive

Positive pregnancy screen during screening

I have hearing problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active THC or placebo over 20 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for memory and intoxication effects after treatment

1 day

Multiple assessments within 4 hours post-infusion

Treatment Details

Interventions

• Placebo
• THC

Trial Overview The study aims to understand how cannabinoids affect memory by comparing the effects of THC (a compound found in cannabis) against a placebo in learning and memory tasks.

Participant Groups

Group I: THC Active Control 2 Interventions

Active THC (0.0015mg/kg-0.03mg/kg) administered over 20 minutes.

Group II: Placebo Placebo Group 2 Interventions

Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.

THC is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Dronabinol for:

• Appetite loss and weight loss in HIV
• Nausea and vomiting from chemotherapy

Approved in Canada as Dronabinol for:

• Appetite loss and weight loss in HIV/AIDS
• Nausea and vomiting from chemotherapy

Approved in European Union as Dronabinol for:

• Appetite loss and weight loss in HIV/AIDS
• Nausea and vomiting from chemotherapy

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Findings from Research

In a study involving 32 regular cannabis users, higher levels of THC in the blood were linked to decreased memory accuracy after cannabis use, indicating that THC can impair memory function in a dose-dependent manner.

Conversely, strains containing both THC and CBD did not show memory impairment, suggesting that CBD may counteract the negative effects of THC on memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of naturalistic THC vs. CBD use on recognition memory: a preliminary study. Curran, T., Devillez, H., YorkWilliams, SL., et al.[2021]

A study involving 431 individuals with chronic non-cancer pain found that using a standardized herbal cannabis product for one year did not increase the risk of serious adverse events compared to non-users, suggesting a reasonable safety profile for medical cannabis.

However, cannabis users experienced a higher rate of non-serious adverse events, mostly mild to moderate, indicating that while cannabis may be safe for serious complications, it can still lead to some side effects that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). Ware, MA., Wang, T., Shapiro, S., et al.[2022]

The FDA approved Syndros, an oral solution containing dronabinol (delta-9-THC), on July 1, 2016, indicating its recognized therapeutic potential.

Following FDA approval, the DEA classified Syndros as a Schedule II controlled substance, reflecting its potential for abuse but also its accepted medical use in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments. [2017]

Natural cannabinoids are increasingly used in medical settings and consumer health products, but they carry risks of adverse drug events and interactions due to their complex pharmacology.

Synthetic cannabinoids are more potent than natural ones and can lead to severe reactions, highlighting the need for caution, especially in vulnerable populations at risk for drug-drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural and Synthetic Cannabinoids: Pharmacology, Uses, Adverse Drug Events, and Drug Interactions. Brown, JD., Rivera Rivera, KJ., Hernandez, LYC., et al.[2022]

The safety of cannabis and cannabinoid medications is a significant concern, and while some safety information can be drawn from recreational use studies, medical and recreational users may experience different effects.

There is a pressing need for long-term safety monitoring of cannabinoid use in patients, as clinical experience is still developing, which will help inform both therapeutic decisions and public policy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. Ware, MA., Tawfik, VL.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

The effect of cannabis use on memory function: an update. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cannabinoids and memory: animal studies. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Systemic or intrahippocampal cannabinoid administration impairs spatial memory in rats. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Cannabinoids alter recognition memory in rats. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Acute effects of naturalistic THC vs. CBD use on recognition memory: a preliminary study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Cannabis for the Management of Pain: Assessment of Safety Study (COMPASS). [2022]

7. England pubmed.ncbi.nlm.nih.gov

A broader view on deriving a reference dose for THC traces in foods. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-transtetrahydrocannabinol (delta-9-THC)] in Schedule II. Interim final rule, with request for comments. [2017]

9. England pubmed.ncbi.nlm.nih.gov

Natural and Synthetic Cannabinoids: Pharmacology, Uses, Adverse Drug Events, and Drug Interactions. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety issues concerning the medical use of cannabis and cannabinoids. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

The cannabinoid CB1 receptor antagonist SR141716A attenuates the memory impairment produced by delta9-tetrahydrocannabinol or anandamide. [2019]