Cannabis for Cognitive Impairment

Overseen By Dustin C Lee, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Any affecting outcomes

Disqualifiers: Substance use disorders, Pregnancy, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Single session per dose

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications that could affect the study outcomes.

What data supports the effectiveness of the drug Cannabis for Cognitive Impairment?

Some studies suggest that cannabidiol (CBD), a component of cannabis, may help improve cognitive function in certain conditions like epilepsy and Alzheimer's disease. However, more research is needed to confirm its effectiveness specifically for cognitive impairment. ^{1 2 3 4 5}

Is cannabis safe for human use?

Cannabis, particularly its component THC, can cause short-term effects like feeling 'high', cognitive issues, and irritability. CBD, another component, is generally considered to have a favorable safety profile and is being studied for various medical uses. However, more research is needed to fully understand the long-term safety of cannabis and its components. ^{2 3 6 7 8}

How does the drug Cannabis differ from other treatments for cognitive impairment?

Cannabis, particularly its components THC and CBD, is unique because it may offer cognitive benefits by potentially reducing inflammation and improving memory, unlike other treatments that do not target these specific mechanisms. Additionally, CBD is noted for its non-intoxicating properties and potential to counteract the cognitive impairments often associated with THC, making the combination of these cannabinoids a novel approach for cognitive impairment. ^{2 3 5 9 10}

Research Team

Dustin C Lee, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for frequent and infrequent cannabis users to study how THC affects eye movements and attention. Participants must be able to consume THC and perform tasks that test their oculomotor function and sustained attention.

Inclusion Criteria

I am a healthy adult between 18 and 60 years old not seeking treatment.

Report infrequent cannabis use defined as at least one reported use in the past year with a negative THC urine toxicology at baseline

Report frequent cannabis use defined as > 5 days per week for > 1 year with a positive THC urine toxicology at baseline

Exclusion Criteria

Meet DSM-V criteria for substance use disorders other than tobacco, cannabis, or caffeine

Test positive for drugs of abuse (other than cannabis) and/or breath alcohol test at study admission

Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying doses of THC (0 mg, 5 mg, 30 mg) to assess oculomotor and cognitive performance

Single session per dose

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabis

Trial Overview The study tests the effects of different doses of THC (0, 5mg, 30mg) on eye movement control and concentration in both regular and occasional cannabis users using a double-blind, placebo-controlled crossover design.

Participant Groups

Group I: 5 mg THC Experimental Treatment 1 Intervention

Inhaled cannabis - 5 mg THC

Group II: 30 mg THC Experimental Treatment 1 Intervention

Inhaled cannabis - 30 mg THC

Group III: 0 mg THC Placebo Group 1 Intervention

Inhaled Cannabis - 0 mg THC

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

Approved in Canada as Cannabis for:

• Chronic pain
• Nausea and vomiting associated with chemotherapy
• Spasticity associated with multiple sclerosis

Approved in United States as Cannabis for:

• Seizures associated with Lennox-Gastaut syndrome and Dravet syndrome
• Nausea and vomiting associated with chemotherapy

Approved in European Union as Cannabis for:

• Spasticity associated with multiple sclerosis
• Chronic pain

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a 2-year observational study of 585 adult patients using medical cannabis, there was a significant increase in the authorization of THC-dominant and CBD-dominant products, indicating a shift in prescribing patterns.

Patients using CBD-dominant or balanced (THC:CBD) products reported greater improvements in anxiety and well-being compared to those using THC-dominant products, suggesting that the cannabinoid profile can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Authorization Patterns, Safety, and Effectiveness of Medical Cannabis in Quebec. Kalaba, M., MacNair, L., Peters, EN., et al.[2021]

Cannabidiol (CBD) has shown significant therapeutic potential for conditions like refractory epilepsy in children, with pharmacological properties such as neuroprotection and anti-inflammatory effects, without the psychotropic effects associated with Δ(9)-THC.

Despite its promise, there are ongoing uncertainties regarding the long-term safety, sourcing, and regulatory challenges of CBD, which are critical for its further clinical development and acceptance in medical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents. Fasinu, PS., Phillips, S., ElSohly, MA., et al.[2018]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Medical cannabinoids for painful symptoms in patients with severe dementia: a randomized, double-blind cross-over placebo-controlled trial protocol. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cannabidiol attenuates deficits of visuospatial associative memory induced by Δ(9) tetrahydrocannabinol. [2021]

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

Use of cannabidiol (CBD) for the treatment of cognitive impairment in psychiatric and neurological illness: A narrative review. [2023]

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

Authorization Patterns, Safety, and Effectiveness of Medical Cannabis in Quebec. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Effect of four-week cannabidiol treatment on cognitive function: secondary outcomes from a randomised clinical trial for the treatment of cannabis use disorder. [2023]

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

Current Status and Prospects for Cannabidiol Preparations as New Therapeutic Agents. [2018]

7. Japan pubmed.ncbi.nlm.nih.gov

[Central Effect of Components of Cannabis: Utility and Risk]. [2020]

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

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

9. Germany pubmed.ncbi.nlm.nih.gov

The effect of tetrahydrocannabinol:cannabidiol oromucosal spray on cognition: a systematic review. [2023]

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

Effects of Chronic, Low-Dose Cannabinoids, Cannabidiol, Delta-9-Tetrahydrocannabinol and a Combination of Both, on Amyloid Pathology in the 5xFAD Mouse Model of Alzheimer's Disease. [2023]