Cannabidiol for Older Adult Cannabis Users

(QUARTz Trial)

Overseen By Kyle A Chrystal, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Boulder

Must be taking: Pain, sleep, mood medications

Must not be taking: Anti-epileptics, antipsychotics, others

Disqualifiers: Psychosis, chemotherapy, other drug use, others

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

385 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new method to reduce potential harm from cannabis use among older adults. Participants will use either full-spectrum CBD (which includes THC), broad-spectrum CBD (without THC), or a placebo over eight weeks. The goal is to assess how these treatments affect pain, anxiety, or mood issues. The trial seeks individuals aged 60 and over who have previously used cannabis without problems and are currently taking medication for pain, sleep, or mood. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not be using certain medications like anti-epileptic drugs or those with major interactions with Epidiolex. You must also be taking medications for pain, sleep, or mood to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that cannabinoids, such as those in hemp-derived CBD products, are generally safe for middle-aged and older adults. However, common side effects can occur, particularly with THC, the compound responsible for causing a high. This is important to consider when using full-spectrum hemp-derived CBD, which contains both CBD and a small amount of THC.

Broad-spectrum hemp-derived CBD does not contain THC and is also generally considered safe. However, these products are not always regulated, raising concerns about whether the label accurately reflects the contents. The listed ingredients might not match what is actually inside. Overall, while CBD is used for issues like pain and anxiety, research on its safety remains limited, so caution and informed use are advised. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore the potential of cannabidiol (CBD) to benefit older adult cannabis users in ways that current therapies might not. Unlike standard treatments, which often involve medications targeting specific receptors or neurotransmitters, these investigational treatments use hemp-derived CBD, known for its anti-inflammatory and neuroprotective properties. The Full-Spectrum CBD (fsCBD) includes a small amount of THC, which may enhance the entourage effect, potentially providing a more comprehensive therapeutic experience. Meanwhile, the Broad-Spectrum CBD (bsCBD) offers a THC-free option, which is appealing for those seeking benefits without psychoactive effects. These approaches could offer new pathways for managing conditions associated with aging and cannabis use, sparking significant interest among researchers.

What evidence suggests that this trial's treatments could be effective for older adult cannabis users?

This trial will compare different formulations of cannabidiol (CBD) for older adult cannabis users. Studies have shown that CBD might help with pain and anxiety, common issues for older adults. Full-spectrum CBD (fsCBD), one treatment in this trial, includes a small amount of THC and may improve mental and emotional well-being, according to research. Early findings suggest that CBD could also help with behavioral and psychological symptoms of dementia. Broad-spectrum CBD (bsCBD), another treatment option in this trial, does not contain THC and is considered safe. Its anti-inflammatory and antioxidant properties might help with aging issues. However, evidence on its effectiveness for pain relief remains mixed. More research is needed to confirm these potential benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for older adults who use cannabis to manage pain, anxiety, or mood problems like depression. Participants will be randomly assigned to one of three groups: one receiving hemp-derived CBD with THC (fsCBD), another getting CBD without THC (bsCBD), and a placebo group.

Inclusion Criteria

I am 60 years old or older.

My liver tests (ALT and AST) are within twice the normal limit.

Able to provide informed consent

Exclusion Criteria

I or someone in my family has been diagnosed with psychosis.

Blood alcohol level > 0 at screening (to sign consent form)

Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of three conditions: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo for an 8-week period

8 weeks

Baseline, 4 weeks, 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The study aims to test the effectiveness of two types of cannabidiol (CBD) as a harm reduction strategy for older cannabis users over an 8-week period. It compares full-spectrum CBD that includes THC (fsCBD) and broad-spectrum CBD that excludes THC (bsCBD) against a placebo.

How Is the Trial Designed?

Group I: Full-Spectrum Hemp-Derived CBD (fsCBD) Experimental Treatment 1 Intervention

8 weeks of use of a daily dose of cannabis (200mg CBD/4mg THC)

Group II: Broad-Spectrum Hemp-Derived CBD (bsCBD) Experimental Treatment 1 Intervention

8 weeks of use of a daily dose of cannabis (200mg CBD)

Group III: Placebo Placebo Group 1 Intervention

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

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of Colorado, Boulder

Lead Sponsor

Trials

128

Recruited

29,600+

Published Research Related to This Trial

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

In a survey of 239 young adults using cannabis, those who preferred CBD-dominant products were more likely to be female, use cannabis less frequently, and report using it primarily for medical reasons such as pain and psychological issues.

The study found a concerning association between CBD use and increased illicit drug use, suggesting that some individuals may be using CBD as a form of self-medication for underlying psychological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol (CBD) and other drug use among young adults who use cannabis in Los Angeles. Fedorova, EV., Wong, CF., Ataiants, J., et al.[2022]

DMDD significantly inhibits the growth of diffuse large B lymphoma (DLBCL) tumors in mice and prolongs their survival, demonstrating its potential as an effective treatment.

In cell studies, DMDD induces apoptosis in DLBCL cells by activating the mitochondrial apoptosis pathway and down-regulating key survival proteins, suggesting a specific mechanism of action through the JAK2/STAT3 and NF-kappa B signaling pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of 2-12alkyl-6-methoxycyclohexa-2, 5-diene-1, 4-dione(DMDD)on diffuse large B lymphoma and its mechanism]. Hong, K., Jiang, PR., Ke, RJ., et al.[2020]

In a study involving six groups of rats, CBD oil significantly improved liver function and antioxidant levels in rats with DMBA-induced leukemia, indicating its potential therapeutic benefits.

The results showed that treating rats with CBD after leukemia induction was more effective than using it as a preventive measure, highlighting its role in improving biochemical and molecular health in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential protective and therapeutic effects of cannabidiol oil on experimental Leukemia induced by DMBA in male rats. Soliman, NA., El Dahmy, SI., Khamis, T., et al.[2023]

Cannabidiol (CBD) has potential therapeutic effects against oxidative stress-related diseases by regulating the Nrf2 pathway, which is crucial for maintaining redox balance and inflammation.

The study highlights that CBD can exhibit both antioxidant and pro-oxidative effects, depending on the cellular context, and its interaction with Nrf2 and NF-κB may influence the cellular response to oxidative stress and cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The molecular activity of cannabidiol in the regulation of Nrf2 system interacting with NF-κB pathway under oxidative stress. Atalay Ekiner, S., Gęgotek, A., Skrzydlewska, E.[2023]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

Next-generation sequencing has enhanced our understanding of the molecular pathways involved in diffuse large B-cell lymphoma (DLBCL), which is crucial for developing targeted therapies.

There are many promising new drugs and immunotherapy options being developed that aim to improve DLBCL treatment by overcoming resistance and exploiting synergistic effects when used in combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel targeted therapies in diffuse large B-cell lymphoma. Mehta-Shah, N., Younes, A.[2018]

Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.

The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]

Older patients with diffuse large B-cell lymphoma (DLBCL) face higher risks of treatment-related toxicity, especially if they are deemed unfit or frail based on comprehensive geriatric assessment (CGA).

Despite these challenges, many older patients can still achieve curative outcomes with standard R-CHOP chemotherapy, highlighting the importance of careful assessment of frailty and comorbidities to guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffuse Large B-Cell Lymphoma in the Elderly: Current Approaches. Allen, P.[2021]

A review of 25 studies involving 927 patients suggests that cannabidiol (CBD) has potential therapeutic effects for conditions like social anxiety disorder and psychotic disorders, particularly with acute administration.

While CBD was generally well tolerated with only mild side effects, the studies showed significant variability in dosage and administration methods, indicating a need for standardized protocols in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosage, Efficacy and Safety of Cannabidiol Administration in Adults: A Systematic Review of Human Trials. Larsen, C., Shahinas, J.[2020]

In a study involving 20 patients with severe behavioral and psychological symptoms of dementia (BPSD), those treated with 3% cannabidiol (CBD) showed significant improvement compared to those receiving usual medical treatment over a six-month period.

The results suggest that CBD may be a safer and more effective option for managing BPSD, indicating a need for larger randomized clinical trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Cannabidiol 3% on Neuropsychiatric Symptoms in Dementia - Six-Month Follow-Up. Alexandri, F., Papadopoulou, L., Tsolaki, A., et al.[2023]

11% of surveyed cannabis users reported using CBD primarily to reduce their cannabis consumption, with significant associations found for those who also smoke tobacco or drink alcohol.

Among those using CBD for reduction, 58.7% reported a large decrease in cannabis use, particularly linked to non-daily cannabis use and daily CBD consumption, with many citing reduced withdrawal symptoms as a key benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "Good" Smoke? The Off-Label Use of Cannabidiol to Reduce Cannabis Use. Fortin, D., Di Beo, V., Massin, S., et al.[2022]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

Citations

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Cannabidiol (CBD) and cognitive function in older adults CBD is considered to be well tolerated in humans and exhibits a favorable safety profile, even at relatively high doses (9, 10). Cannabidiol ...

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Cannabidiol (CBD) Use by Older Adults for Acute and Chronic ... A review of the literature demonstrated mixed results on the efficacy of using CBD in relieving pain in the older adult.

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Cannabidiol for Older Adult Cannabis Users (QUARTz Trial) The results suggest that CBD may be a safer and more effective option for managing BPSD, indicating a need for larger randomized clinical trials to confirm ...

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The impact of cannabis use on ageing and longevity Interestingly, the lowest THC dose (0.08 µM) showed promising results, increasing male survival and egg production in adults while reducing ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S075333222300865X

The role of cannabidiol in aging CBD is a potential antiaging candidate. CBD possesses antioxidant, anti-inflammatory and autophagy-inducing properties.

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Adverse events caused by cannabinoids in middle aged and ... 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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Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Non-FDA-approved CBD products lack safety standards, may have contaminants, and may contain THC. Limited evidence supports their safety.

8. fda.gov fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

What to Know About Products Containing Cannabis and CBD The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

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Cannabidiol Use in Older Adults CBD is used for pain, anxiety, and sleep in older adults, but evidence is insufficient, and safety concerns exist, including mislabeling and ...

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Safety and tolerability of natural and synthetic cannabinoids in ... Although THC-containing CBMs are associated with side effects, CBMs in general are safe and acceptable in older adults.