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Medical Cannabis for Older Patients—Treatment Protocol and Initial Results

Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).

Abstract

Older adults may benefit from cannabis treatment for various symptoms such as chronic pain, sleep difficulties, and others, that are not adequately controlled with evidence-based therapies. However, currently, there is a dearth of evidence about the efficacy and safety of cannabis treatment for these patients. This article aims to present a pragmatic treatment protocol for medical cannabis in older adults. We followed consecutive patients above 65 years of age prospectively who were treated with medical cannabis from April 2017 to October 2018. The outcomes included treatment adherence, global assessment of efficacy and adverse events after six months of treatment. During the study period, 184 patients began cannabis treatment, 63.6% were female, and the mean age was 81.2 ± 7.5 years (median age-82). After six months of treatment, 58.1% were still using cannabis. Of these patients, 33.6% reported adverse events, the most common of which were dizziness (12.1%) and sleepiness and fatigue (11.2%). Of the respondents, 84.8% reported some degree of improvement in their general condition. Special caution is warranted in older adults due to polypharmacy, pharmacokinetic changes, nervous system impairment, and increased cardiovascular risk. Medical cannabis should still be considered carefully and individually for each patient after a risk-benefit analysis and followed by frequent monitoring for efficacy and adverse events.

1. Introduction

The recent interest and use of medical cannabis (MC) are growing substantially in many countries. The regulations on its use vary among countries, affecting medical practice and experience [1]. Current public opinion is that cannabis has the therapeutic potential to treat and cure a long list of diseases, but there is a large gap between that opinion and the current evidence in the medical literature [2]. Another common opinion is that MC is mainly used by young adults. However, the use of MC by older adults is increasing [3], and studies show variable prevalence, ranging from approximately 7% to more than one-third, depending on the country [4,5]. Recreational use of cannabis by older adults is also increasing substantially, especially in the United States [6].

Relief of suffering and promotion of functional status and quality of life are major goals of geriatric medicine. Chronic pain, Parkinson’s disease, depression, sleeping disorders, and malnutrition are all common among older adults [7,8,9,10,11,12]. Current medical treatments of these syndromes can have serious adverse events, frequently endangering patients’ health. For example, some non-steroidal anti-inflammatory drugs (NSAIDs) are associated with gastrointestinal bleeding, renal impairment, and cardiovascular adverse events [13]. Sedative hypnotics can cause psychomotor impairment, dizziness, confusion, increased risk of falls, next-day somnolence, impairment of driving skills, orthostatic hypotension, and blood electrolyte impairment [14]. Opioid treatment causes constipation, nausea, vomiting, drowsiness, delirium, sedation, anticholinergic effects, falls, and respiratory depression, which is the most serious potential adverse effect [13]. Beyond individual factors, current concerns about opioid-related deaths have greatly influenced our thinking about pain management and medication treatment [15].

1.1. Efficacy and Indications for Medical Cannabis in Older Adults

The geriatric population may benefit from cannabis treatment for a variety of symptoms, such as chronic pain, sleep difficulties, tremor, spasticity, agitation, nausea, vomiting, and reduced appetite. Cannabis may also be useful in palliative care. However, currently, there is a dearth of evidence about the efficacy of cannabis in older adults for any of these symptoms. This has been emphasized in several reviews [16,17,18] and in large reports such as the report of the National Academies of Sciences in the United States [19] and the Information for Health Care Professionals in Canada [20].

1.2. Chronic Pain

Chronic pain is one of the most common indications for prescribing MC. The report by the National Academies of Sciences concludes that cannabis is effective for the treatment of chronic pain in adults [19]. Despite this conclusion and a large number of studies, including randomized controlled trials, the efficacy for cannabis as a chronic pain medication remains in dispute [21]. Pain relief is very often cited as a reason for MC use among older individuals. For example, 89.7% of the older patients in the Colorado MC registry listed pain as their primary or secondary condition [4]. All the large studies that evaluated cannabis for pain have included older adults in the inclusion criteria, but their number was small, or they were not analyzed separately for safety and efficacy [21,22].

1.3. Parkinson’s Disease

Parkinson’s disease (PD) is a common neurodegenerative disease found mostly among older adults, which is caused by dopaminergic neuron loss. It is mainly characterized by motor symptoms that include bradykinesia in combination with resting tremor or rigidity [23]. PD also has a distinct prodromal stage identified by non-motor symptoms, such as olfactory dysfunction, constipation, urinary dysfunction, depression, anxiety, and pain [24]. Two small-scaled randomized controlled trials failed to demonstrate the efficacy of cannabis in treating the motor symptoms of PD [25,26]. However, cannabis might improve quality of life in PD and relieve other non-motor symptoms [27].

1.4. Sleep Difficulties

Approximately 50% of people above age 65 complain about sleeping difficulties, and there is an increase in sleep disturbances in old age [28]. Care must be taken not to mistake geriatric sleep complaints for physiological aging, as these complaints are mainly attributable to medical, psychiatric and health-related burdens [29]. It should be noted that sleep disturbances are among the most frequent complaints of cannabis withdrawal, and are a major cause for continued use after attempts to quit [30]. Both pharmacological and non-pharmacological treatments are used to address sleep disorders among older individuals [31]. A meta-analysis evaluating the therapeutic effect of cannabis on sleeping disturbances has not reached a decisive conclusion. The effects of cannabis on the sleep–wake cycle are also unclear [32], though some research suggests that cannabis might aid in sleep disorders due to its anxiolytic effect [30].

1.5. Nausea and Vomiting

A Cochrane review concluded that “Cannabis-based medications may be useful for treating refractory chemotherapy-induced nausea and vomiting” [33]. A more recent review states that there is low-quality evidence that cannabinoids prevent nausea and vomiting as compared to other agents or a placebo [34]. The only study that addressed this issue in older adults was in 1982, and it found no difference between tetrahydrocannabinol (THC) and prochlorperazine in reducing nausea and vomiting [35].

1.6. Post-Traumatic Stress Disorder (PTSD)

The efficacy of cannabis treatment for PTSD in older individuals was not evaluated thus far in any study. Several studies evaluated the efficacy of cannabis treatment for PTSD in younger adults, but these studies also failed to demonstrate a clear effect of MC treatment for these patients [21].

1.7. Dementia

Dementia is a prevalent condition in older adults causing cognitive decline [36]. Small studies that used Dronabinol, oral synthetic Δ 9 -THC, or an extract of THC from plants, showed it improved neuropsychiatric symptoms, agitation, nocturnal motor activity, sleep duration, and meals consumption in dementia patients, while only a few serious adverse events were observed [37,38,39].

However, a study conducted with Namisol, an oral tablet containing ≥98% natural ∆ 9 -THC, showed it did not reduce neuropsychiatric symptoms, agitation, activities of daily living, or improved quality of life in dementia patients [40].

1.8. Palliative Treatment

A recent systematic review and meta-analysis were unable to make any recommendation about the use of cannabis in palliative care after evaluating studies that included mainly younger adults and a small number of older adults [41].

2. Special Considerations and Precautions

2.1. Pharmacokinetics, Pharmacodynamics, and Drug Interactions

It is well known that aging is associated with substantial changes in pharmacokinetics and pharmacodynamics. For instance, hepatic drug clearance, as well as renal elimination, are both decreased in older adults. Furthermore, aging is associated with increased body fat and decreased lean body mass [42], which increases the volume of distribution for lipophilic drugs, such as cannabis. Two small studies evaluated the pharmacokinetics and pharmacodynamics of older adults who received an oral drug containing pure THC. These phase I and phase II trials included 12 healthy older adults and 10 older adults with dementia, respectively, and found smaller pharmacodynamic effects of THC in both groups, although the pharmacokinetic data showed substantial inter-individual variation [43,44]. Interaction between cannabis products and other drugs is also largely unknown, as the current evidence from human studies is sparse [45]. Concomitant administration of cannabis with other drugs that influence the hepatic CYP family enzymes may greatly alter the metabolism of the cannabinoids [46]. This issue is especially important in the geriatric population, where polypharmacy is common [47].

2.2. Nervous System Impairment

The common adverse effects experienced by patients due to cannabis use include dizziness, euphoria, drowsiness, confusion, and disorientation [16]. These effects are particularly important in the geriatric population, which may have conditions such as dementia, frequent falls, mobility problems, hearing, or vision impairments [48]. The long-term effect of adult cannabis use on cognition is unclear. Two systematic reviews showed evidence that long-term use of cannabis is associated with negative effects on some cognitive functions, but evidence of enduring negative effects was weak [49,50].

2.3. Cardiovascular Risks

The effects of cannabis on cardiovascular diseases are not yet well established. In recent years, however, there has been an increasing number of case series and reports concerning young, healthy recreational cannabis users who suffer from arrhythmias, myocardial infarction, and even sudden cardiac death [51]. Direct causality has not been proven, but the implication is that care must be taken concerning older adults since they have more cardiovascular comorbidities and risk factors.

The acute cardiovascular effects of cannabis, based on studies performed on younger individuals, include an increase in sympathetic activity that causes an increase in heart rate, cardiac output, and myocardial oxygen demand. Tolerance of the effects of cannabis on heart rate develops rather quickly in young people [52].

This article aims to present a novel medical cannabis treatment protocol in older adults and the initial results from its use. The protocol will be presented in the Discussion segment of the manuscript.

3. Methods

3.1. Patients and Methods

Israeli medical cannabis regulations include a number of indications and recommendations for its use [1]. We have adopted the general recommendations to suit the physiological and pathophysiological needs of the elderly. In 2017, NiaMedic established a specialized geriatric clinic to provide MC therapy within a comprehensive geriatric platform. We have followed 184 consecutive patients above 65 years of age prospectively who were treated with MC from April 2017 to October 2018. The patients were followed for at least six months since treatment initiation. The inclusion criteria were age of 65 years and above and any of the following indications for cannabis treatment: chronic cancer pain and non-cancer pain, Parkinson’s disease, sleep disorders, anorexia, post-traumatic stress disorder, spasticity, and palliative treatment. The exclusion criteria were severe cardiovascular diseases, such as heart failure or a recent major myocardial infarction, liver failure, psychotic comorbidities, and those with a history of addictions. The follow-up evaluation includes detailed questioning regarding adverse events, adherence to treatment, and its efficacy.

3.2. The Treatment Protocol

As previously mentioned, the regulations of cannabis and its products vary by country, which affects the clinical experience of physicians. In Israel, cannabis can be prescribed for the following conditions: nausea and vomiting due to chemotherapy treatment, cancer-associated pain; Crohn’s disease, ulcerative colitis; neuropathic pain; AIDS patients with Cachexia; multiple sclerosis, Parkinson’s disease, Tourette syndrome, epilepsy (both adult and pediatric population); palliative treatment; post-traumatic stress disorder [1]. The initially approved dosing is 20 grams of cannabis compound per month (0.6 grams per day), with a cannabis product that contains the lowest concentration of active ingredients, but without limitation to the ratio of the different cannabinoids. The only cannabinoid-based medicine that is approved at the time of this manuscript preparation is Nabiximols, and its use is infrequent. Thus, we provide here our approach that is based on the available literature, data analysis, and our clinical experience with treating older adults with herbal cannabis, which includes the cohort above and previously published data [53]. We offer many recommendations consistent with Minerbi et al. and MacCallum et al. [17,54].

3.3. Ethics

Our study collected all the relevant clinical data as a part of the routine medical practice. Thus, Soroka University Medical Center institutional review board (IRB) Committee approved the protocol and waived the request for informed consent (confirmation number 0036-18-SOR). All clinical investigations were conducted according to the principles expressed in the Declaration of Helsinki.

4. Results

We present here initial data from a cohort of patients who initiated MC therapy between April 2017 and October 2018. Most of our patients, 83.2% (n = 153) were 75 years of age or older, and 63.6% (n = 117) were females. The demographic characteristics, the comorbidities of the patients, and the indications for cannabis treatment are detailed in Table 1 . When we evaluated the patients after six months of MC treatment, we found that 58.1% were still using cannabis, 8.1% discontinued the treatment, 10.9% were lost to follow-up, and 17.9% did not complete six months of treatment by the time of the analysis. Of the 122 patients eligible to respond, 91.8% (n = 112) globally assessed the effect of cannabis on their general condition, with 84.8% of them reporting some degree of improvement ( Figure 1 ). Of the patients who were still treated with cannabis, 33.6% reported adverse events, the most common of which were dizziness (12.1%), sleepiness and fatigue (11.2%), dry mouth (5.6%), and psychoactive sensation (5.6%). Since well-established and evaluated protocols for treatment of older adults with cannabis do not exist, we have developed our own approach based on close follow-up of effects, adverse events, and slow titration.

CBD Safety For Seniors

Almost one in five Americans over 50 now uses some kind of CBD product, according to a recent Gallup poll. And they are doing so undeterred by the total lack of FDA oversight or guidelines. But to what extent is CBD use a public health concern for seniors? And what do older adults need to consider when they start using CBD?

Fake product alert

Hemp-derived CBD oil is now poised to overtake olive oil in the category of most counterfeited plant extract on the planet, making authenticity a prime concern for older consumers. Random samplings of CBD products consistently detect misrepresentation between their labels and their contents. In some cases, the nominal cannabinoid is entirely absent, in others, more nefarious substances have been found.

One of the many organic, third-party lab-tested CBD products on the market.

Hence, until the FDA gets its regulatory house in order, responsibility for finding a safe product lies with the consumer. According to the Brightfield Group, seniors tend to prefer ingesting CBD in oils, vape cartridges and edibles, which entails a lot of label-reading for seniors. When evaluating a CBD product, make sure it uses CBD from organic hemp, preferably grown in the United States, and that it is third-party lab tested to verify the CBD content and rule out the presence of contaminants.

Once you get it, how do you use it?

While CBD products have never been easier to access in the US, actually getting the desired results from them can be more complicated.

I spoke with Dr. Danial Schecter, an Ontario-based family physician who is the co-founder of a network of cannabis-based medicine clinics that have served over 60,000 patients in Canada, and who recently became Director of Global Medical Services at Canopy Growth Corporate, about the guidance he suggests for seniors interested in using CBD.

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Danial Schecter (DS) I’ll start with a few basics: CBD is a molecule derived from the cannabis plant. It is what we call non-euphoric-inducing, in that it doesn’t cause you to feel high, but it is still what we call psychoactive, meaning that it has an effect on the neurotransmitters and the chemistry of your brain, just like an antidepressant or a sleep aid would have.

Abbie Rosner (AR): How do you approach CBD dosage for seniors?

DS: When we’re talking about CBD, in terms of dosing it in particular, we know that doses of CBD are very safe, that there has been no documented overdose of CBD, that it does not cause euphoria and that it is safe to be used in quite high quantities. We have studies where it’s been used in as low as 5-10 mgs per day, and studies that are using it in as high as 1500 mgs a day.

The supposed effects of CBD are that it has anti-inflammatory, antidepressant and anxiolytic (anti-anxiety) properties – but we still don’t really know exactly how it works. Yet there have been studies done in humans, for example, where subjects were given 600 mg of CBD in a single dose or a placebo, and then had them do a simulated public speaking exercise. And those who had the CBD had a significantly easier time, with less anxiety.

But, in clinical practice, we never give doses like that. It’s just not affordable. What I see in my clinical practice is that the majority of people will respond to somewhere between 40 and 100 mgs of CBD/day.

AR: If a 70 year old woman came into your clinic, would you recommend that she take 40 mg of CBD?

DS: No. What I would say is, we don’t know what your dose is going to be. Everyone’s endocannabinoid tone is different, their metabolism is different, you’re on a certain number of medications that will potentially affect the metabolism of CBD and the only way to know if it is going to work and what the dosage is, is by taking a standardized approach, starting low and going slow.

AR: And what would the starting dose be?

DS: In a healthy adults a starting dose would usually be 5 mg of CBD, but in people who are elderly, who are potentially on a number of medications, and who are very sensitive to side-effects of medications, we like to cut that dose in half, and start at 2.5 mgs of CBD. The 40-100 mgs a day of CBD a day that I mentioned previously, that’s usually for people who are using it for pain or for anxiety and wellbeing.

AR: Pain and anxiety are two of the main issues that older adults are facing – so the picture that I’m getting is that, if an older adult comes in and says, I have pain and I’d like to start with CBD – you’d start low but you might theoretically get up to 40-100 mgs of CBD to actually address the effects.

DS: Exactly – so what we usually do is, we encourage people to start at a very low dose – 2.5 mgs – and then increase in 2.5 mg increments – depending on how aggressive they want to be – over anywhere between 2 days and one week. And then wait to see if they feel any kind of response.

Usually, the psychological symptoms will take longer to actually improve or respond to CBD than the physical symptoms. So we would often recommend a slower titration for anxiety or depression, and for the physical symptoms that have a quicker response, we could recommend a quicker titration.

AR: What do you recommend for seniors who want to supplement or replace their medications with CBD?

DS: Whenever we want to start a new medication, one of the very basic principles is that we should really not be playing around with another medication. So you only want to introduce or remove one medication at a time.

If you’ve been on a sleep aid for many years, and you want to stop taking it and use CBD, I would not recommend that you all of a sudden stop taking the sleep aid and start taking CBD, because your insomnia will get worse. Under the guidance of your physician, you would want to taper in the CBD until you reach a stable dose.

AR: Is CBD alone a potent medication?

DS: It can be. But it’s probable that the best benefits – at least what I see in clinical practice – is when we can use a combination of both THC and CBD.

There is idea that exists that THC is bad and CBD is good, when in actuality, both of these molecules have a very important place in clinical practice. And while THC has received a bad rap, because it is associated with getting high, in actuality, it has more immediate benefits than CBD. With THC there’s a huge misconception that people just use it to get high. But in doses that do not cause you to get high, it can be very beneficial for things such as sleep, pain, nausea, appetite stimulation and muscle spasms.

AR: That’s all fine and well in Canada. But in most of the United States, older adults need to get a medical marijuana card to access those products –with all the bureaucracy that entails. And now they can access CBD in almost any drugstore – and that’s what they’re doing!

DS: For someone who wants to access CBD on the open market, that’s absolutely fine – but ideally, they would be doing so under the supervision of their main treating physician.

AR: In your practice, are you seeing older adults who are asking for CBD products?

DS: That’s actually what we’re seeing the most of these days. In Canada, where cannabis has been legalized for recreational use, the greatest increase in our patient population at the clinics are the Baby Boomers and the parents of Baby Boomers who are coming in all the time asking to try that CBD oil.

But the other thing is that, even when they want CBD, once we start examining them, getting their history and understanding what it is they are looking for, we find that very often they would benefit from a low dose of THC in addition to CBD. Here in Canada, you can very easily say, I know you’ve heard about CBD, but you could benefit even more from something with a little THC.

AR: And there’s the beauty of full legalization – that you don’t have to jump through so many hoops to get a little THC in your medicine.