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

5 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Cannabis for elder care services?

Some studies suggest that cannabis, particularly THC and CBD, may help with symptoms like pain, agitation, and weight loss in older adults with conditions such as dementia. However, more research is needed to confirm these benefits and understand the safety of cannabis use in older populations. ^{1 2 3 4 5}

Is cannabis safe for older adults?

Research shows that cannabis, including products with CBD and THC, is being used by older adults for conditions like pain, and some studies suggest it can be used without adverse effects. However, more evidence is needed to fully understand its safety in this age group. ^{6 7 8 9 10}

How does cannabis differ from other treatments for elder care services?

Cannabis is unique for elder care as it can be used in various forms like sublingual tinctures, which are preferred by older adults, and often starts with a lower THC and higher CBD dose. Unlike traditional medications, cannabis may offer benefits for conditions like chronic pain, sleep disturbances, and agitation in dementia with potentially fewer side effects. ^{2 11 12 13 14}

What is the purpose of this trial?

This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults.

Research Team

Alison Oliveto, PhD

Principal Investigator

University of Arkansas

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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

Cannabis Use and Misuse in Older Adults. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

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

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

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

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

Efficacy and safety of medical cannabinoids in older subjects: a systematic review. [2018]

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

Cannabis for Chronic Osteoarthritis Pain: A Case of an Older Person. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Medication-related emergency department visits and hospitalizations among older adults. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Acute adverse event signalling scheme using the Saskatchewan Administrative health care utilization datafiles: results for two benzodiazepines. [2013]

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

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

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

Safety and tolerability of natural and synthetic cannabinoids in adults aged over 50 years: A systematic review and meta-analysis. [2023]

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

Cannabis use for Sleep Disturbance Among Older Patients in a Geriatrics Clinic. [2023]

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

Patterns of Medical Cannabis Use Among Older Adults from a Cannabis Dispensary in New York State. [2023]

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

Medical Cannabis for Older Patients. [2020]

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

Use of Cannabis for Agitation in Patients With Dementia. [2021]