Cannabis Effects for Elder Care Services

Overseen By Alison Oliveto, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Arkansas

Must not be taking: Antidepressants, Anticoagulants, Sildenafil, others

Disqualifiers: Substance use disorders, Psychosis, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cannabis brownies affect mood, thinking, movement skills, balance, and vital signs in older adults. It aims to determine if cannabis can safely assist in these areas. Individuals who have previously used marijuana without serious side effects, are fluent in English, and have stable health conditions may be suitable candidates. Participants must not have used tobacco, nicotine, or cannabis products recently.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking medications for psychiatric disorders or any drugs that interact with THC. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cannabis can be safe for middle-aged and older adults, but some side effects require attention, especially for seniors. Common side effects include dizziness, confusion, and mood changes. Some studies suggest that cannabis might affect heart health and memory in older adults.

Experts note that these side effects often depend on the amount of THC, a key ingredient in cannabis. Higher amounts might cause stronger effects. Additionally, people over 55 might be more sensitive to these effects than younger individuals.

Seniors should be aware of these possible risks. Understanding how cannabis might affect the body can help individuals make informed choices. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using cannabis in elder care because it offers a novel approach to managing symptoms often treated with pharmaceuticals like opioids or anti-anxiety medications. Unlike these standard treatments, cannabis is derived from a natural plant source and can be administered in the form of edible brownies, providing a potentially more palatable and less invasive delivery method. Moreover, cannabis interacts with the body's endocannabinoid system, which could offer unique benefits in terms of pain relief and mood enhancement, potentially reducing the need for multiple medications and their associated side effects.

What evidence suggests that cannabis might be an effective treatment for mood and cognitive performance in older adults?

Research suggests that cannabis might aid older adults, particularly with mood and cognitive skills. Early studies have shown that cannabinoids, compounds in cannabis, can positively impact lifespan and mental abilities. Many older adults use cannabis to manage anxiety and depression, though doctors do not all agree on its effectiveness for these issues. As people age, they might experience THC, the active component of cannabis, more intensely due to bodily changes. While the evidence remains inconclusive, early findings indicate potential benefits worth further exploration. Participants in this trial will receive up to three doses of cannabis in brownie form to investigate these potential benefits. ^{1 2 6 7 8}

Who Is on the Research Team?

Alison Oliveto, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for older adults who have not used psychoactive drugs, tobacco, or cannabis recently. They must be in stable health with controlled medical conditions and no history of serious substance abuse or cognitive disorders. Women must be post-menopausal or not capable of bearing children.

Inclusion Criteria

You have used marijuana before, but it did not cause any serious problems for you.

Blood pressure (BP) reading ≤140/90 and ≥110/70 at the time of screening

Negative breath alcohol concentration

Exclusion Criteria

You currently smoke or use tobacco/nicotine products.

I am not taking any medication that interacts badly with THC.

I am allergic or have had bad reactions to cannabis or brownie ingredients like gluten, chocolate, or eggs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three 7.5-hour experimental sessions conducted one week apart, receiving cannabis in various doses and undergoing assessments of subjective, cognitive, and physiological effects.

3 weeks

3 visits (in-person)

Follow-up

Participants are contacted the day after each session for feedback on session acceptability and any adverse events.

3 weeks

3 follow-up contacts (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabis

Trial Overview

The study tests the effects of up to three doses of cannabis on mood, cognition, psychomotor performance, balance, and vital signs in older adults to understand how it affects them differently than younger populations.

How Is the Trial Designed?

Group I: Cannabis (up to three doses) Experimental Treatment 1 Intervention

Brownies containing a dose of cannabis

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

Cannabinoids, particularly those containing both THC and CBD, have shown neuroprotective effects and can safely reduce agitation in older adults with dementia, based on previous studies.

Unlike traditional dementia medications that often have significant side effects, cannabinoids are generally well tolerated with few short-term adverse effects, highlighting their potential as a safer alternative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Cannabis for Agitation in Patients With Dementia. Mueller, A., Fixen, DR.[2021]

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]

In a study of 30 Alzheimer's disease patients aged 65-90, the administration of a THC:CBD cannabis extract for 12 weeks significantly reduced symptoms such as agitation, irritability, and sleep disturbances, improving caregiver distress.

The study also found that 45% of patients showed a significant decrease in cognitive impairment, indicating potential efficacy of cannabis extracts in managing severe symptoms of Alzheimer's disease, despite limitations like the small sample size and lack of a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral THC: CBD cannabis extract in main symptoms of Alzheimer disease: agitation and weight loss. Palmieri, B., Vadalà, M.[2023]

Citations

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Although CBMs in general are safe and acceptable in middle aged and older adults, one needs to be mindful of certain common dose-dependent side-effects of THC- ...

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