The vast majority of subjects in Sativex clinical trials do not experience psychotropic effects outside of initial dose titration intervals (Figure 2) and most often report subjective intoxication levels on visual analogue scales that are indistinguishable from placebo, in the single digits out of 100 (Wade et al 2006). Thus, it is now longer tenable to claim that psychoactive effects are a necessary prerequisite to symptom relief in the therapeutic setting with a standardized intermediate onset cannabis-based preparation. Intoxication has remained a persistent issue in Marinol usage (Calhoun et al 1998), in contrast.
But the CBD oil use that might be most intriguing—and could perhaps be the biggest game-changer—is for pain relief. As the United States grapples with the opioid epidemic and struggles to treat the 50 million plus Americans who struggle with chronic pain, CBD oil has emerged as a nonaddictive alternative that people are applying as a topical oil, ingesting as a pill, or smoking through a vape pen.
According to the U.S. Department of Health and Human Services, 116 people died every-day from opioid-related drug overdoses in 2016. Forty percent of these deaths involved a prescription opioid and in 2017, the government declared the opioid crisis a public health emergency. Opioids are prescribed by health care providers as a way to manage and treat pain. But what if there was a better solution?
Hemp is a controversial crop in some regions of the world, due to concerns about psychoactive plants in the Cannabis genus. In some regions, cultivation of hemp is banned, although products made from hemp such as oil, hemp garments, and hemp paper may be legal. In other areas, hemp is permitted, but only industrial hemp, and some nations freely permit cultivation of all plants in this genus, assuming that regulation is a more efficient technique for control than outright bans. Wild hemp is also not uncommon in some regions of the world, making it difficult to enforce bans on hemp crops.
If you are living with chronic pain, hemp offers you hope. CBD can be purchased online or over the counter in many forms in every state in the U.S., and many places around the world. The good news is CBD has a very broad safety profile, and you should feel comfortable trying it. Dosing is going to be a key, and we’ll discuss that in a later column. Taking too much won’t harm you, but it might not help you either. Please be sure to talk to your physician about CBD. In my next column, I will offer some tips for having this conversation, particularly if you feel awkward about cannabis or hemp, or suspect your doctor might react badly to your interest.
Our reviews also include the ingredients and a description of the scent and texture of each CBD topical. We tried to remain neutral in our descriptions of each product, since each consumer’s experience is subjective. These are all high-quality CBD creams, balms and salves, but you may find you prefer one scent over another. You might love or hate menthol. Some people prefer a light texture, while other buyers are looking for CBD topicals to use in a massage.
Sativex® (GW Pharmaceuticals) is an oromucosal whole cannabis-based spray combining a CB1 partial agonist (THC) with a cannabinoid system modulator (CBD), minor cannabinoids and terpenoids plus ethanol and propylene glycol excipients and peppermint flavoring (McPartland and Russo 2001; Russo and Guy 2006). It was approved by Health Canada in June 2005 for prescription for central neuropathic pain in multiple sclerosis, and in August 2007, it was additionally approved for treatment of cancer pain unresponsive to optimized opioid therapy. Sativex is a highly standardized pharmaceutical product derived from two Cannabis sativa chemovars following Good Agricultural Practice (GAP) (de Meijer 2004), yielding Tetranabinex® (predominantly-THC extract) and Nabidiolex® (predominantly-CBD extract) in a 1:1 ratio. Each 100 μL pump-action oromucosal Sativex spray actuation provides 2.7 mg of THC and 2.5 mg of CBD. Pharmacokinetic data are available, and indicate plasma half lives of 85 minutes for THC, 130 minutes for 11-hydroxy-THC and 100 minutes for CBD (Guy and Robson 2003). Sativex effects commence in 15–40 minutes, an interval that permits symptomatic dose titration. A very favorable adverse event profile has been observed in over 2500 patient years of exposure in over 2000 experimental subjects. Patients most often ascertain an individual stable dosage within 7–10 days that provides therapeutic relief without unwanted psychotropic effects (often in the range of 8–10 sprays per day). In all RCTs, Sativex was adjunctively added to optimal drug regimens in subjects with intractable symptoms, those often termed “untreatable.” Sativex is also available by named patient prescription in the UK and the Catalonia region of Spain. An Investigational New Drug (IND) application to study Sativex in advanced clinical trials in the USA was approved by the FDA in January 2006 in patients with intractable cancer pain.
What are some statistics from research of long-term use of CBD oil when used for chronic pain? How does this unregulated supplement effect our bodies when used over the course of, for example, one or more years? Just because something is natural does not make it safe for human consumption, especially for daily use over the course of many months/years. I’m not trying to put a negative spin on CBD oil but am cautiously optimistic…cautious being the operative word here because I (like many others here) have tried soooo many alternative therapies before finding that opioids work for me to control my chronic pain after 2 spinal fusions, degenerative disc disease effects, , osteoarthritis effects, carpal tunnel syndrome wear and tear, a broken sternum, 2 broken thoracic vertebrae and 2 spinal compression fractures. CBD oil purchase will likely not be reimbursed by insurance companies because it is not FDA approved and, therefore, our government cannot profit from its cultivation, processing and sales.
Locsta....I share your pain of degenerative and bulging disk disease, along with fibromyalgia, chronic fatigue and arthritis. Absolutely no energy and chronic pain all day, every day. I'm curious as to what type and brand of the CBD oil you are taking and for how long have you been using it? I've been researching CBD oil for months and am quite confused!
Fourth, CBD oil is believed to be effective against pain and inflammation, and, in its pure form, it's generally regarded as safe. Especially in light of the theory that ME/CFS is related to neuroinflammation, and the wealth of evidence pointing to it being an inflammatory disease, it's pretty obvious that there's a potential benefit that should be explored.
Almost everything we use in our diet to prevent or manage health problems has some risk of side effects, and hemp oil is no exception. Firstly it is important to note, however, that negative side effects of hemp oil are rare and some only occur in extreme cases, they can also be considered minor in comparison to the side effect of pharmaceuticals. To date, there have been no reported cases of toxicity from the ingestion of hemp seed oil.
Even more intriguing: CBD also influences many non-cannabinoid receptor systems in the brain, interacting with receptors sensitive to a variety of drugs and neurotransmitters (Figure 2). These include opioid receptors, known for their role in pain regulation. Opioid receptors are the key targets of pharmaceutical pain killers and drugs of abuse such as morphine, heroin, and fentanyl. CBD can also interact with dopamine receptors, which play a crucial role in regulating many aspects of behavior and cognition, including motivation and reward-seeking behavior.
Similarly, while Sativex and smoked cannabis have not been employed in the same clinical trial, comparisons of side effect profiles can be made on the basis of SAFEX studies of Sativex for over a year and up to several years in MS and other types of neuropathic pain (Russo 2006b; Wade et al 2006), and government-approved research programs employing standardized herbal cannabis from Canada for chronic pain (Lynch et al 2006) and the Netherlands for general conditions (Janse et al 2004; Gorter et al 2005) over a period of several months or more. As is evident in Figure 2 (Figure 2), all adverse events are more frequently reported with herbal cannabis, except for nausea and dizziness, both early and usually transiently reported with Sativex (see (Russo 2006b) for additional discussion).
CBD does not appear to have any psychotropic ("high") effects such as those caused by ∆9-THC in marijuana, but may have anti-anxiety and anti-psychotic effects. As the legal landscape and understanding about the differences in medical cannabinoids unfolds, it will be increasingly important to distinguish "medical marijuana" (with varying degrees of psychotropic effects and deficits in executive function) – from "medical CBD therapies” which would commonly present as having a reduced or non-psychoactive side-effect profile.
For some chronic pain sufferers, a simple hug can turn into a horrible event. What is usually a comforting, therapeutic, loving gesture has layers of complexity. It hurts to be hugged, but you don’t want to say anything because it hurts the “hugger’s” feelings. Plus, you’re not sure if they’ll believe you — I mean, it sounds pretty dramatic to say you’re in so much pain you can’t tolerate a hug. Calming pain, anxiety, and the PTSD trigger response all help very much in these tough situations. Maybe with a nervous system nourished via the endocannabinoid system with CBD, you’ll be able to gently express that hugs aren’t for you.
Inflammation is the health buzz-word of the day. And for good reason — chronic inflammation (defined as swelling that extends beyond the initial healing process needed to address an acute illness or wound) causes pain and eventually damages tissue. Long-term use of pharmaceutical grade NSAIDs and over-the-counter pain killers have side effects on the liver, kidney, and stomach. For short-term usage, they are effective and helpful, but demand for long-term solutions that do not damage the body are in high demand. CBD fits the bill. It only has one major side effect — too much will make you sleepy. So play with your dose and find the right balance for you. A little less in the daytime, and a little more at night if sleep is also a problem.
Epilepsy. A specific cannabidiol product (Epidiolex, GW Pharmaceuticals) has been shown to reduce seizures in adults and children with various conditions that are linked with seizures. This product is a prescription drug for treating seizures caused by Dravet syndrome or Lennox-Gastaut syndrome. It has also been shown to reduce seizures in people with tuberous sclerosis complex, Sturge-Weber syndrome, and febrile infection-related epilepsy syndrome (FIRES). But it's not approved for treating these other types of seizures.
You'd be surprised. The applications of the cannabis plant are many, and beauty nerds are having a heyday with it, extolling its purported anti-inflammatory, antioxidant, emollient, and regenerative properties as a treatment for everything from acne to psoriasis to signs of aging. For me, one of the most exciting developments is the increasing availability of topical lotions, oils, and creams that go heavy on a compound called CBD, the common shorthand for Cannabidiol. It's become my secret weapon for getting comfy during a flight, soothing a strained neck on a long car ride, or calming my aching feet after a day of hiking.
Very few randomized controlled trials (RCTs) have been conducted using smoked cannabis (Campbell et al 2001) despite many anecdotal claims (Grinspoon and Bakalar 1997). One such study documented slight weight gain in HIV/AIDS subjects with no significant immunological sequelae (Abrams et al 2003). A recent brief trial of smoked cannabis (3.56% THC cigarettes 3 times daily) in HIV-associated neuropathy showed positive results on daily pain, hyperalgesia and 30% pain reduction (vs 15% in placebo) in 50 subjects over a treatment course of only 5 days (Abrams et al 2007) (Table 1). This short clinical trial also demonstrated prominent adverse events associated with intoxication. In Canada, 21 subjects with chronic pain sequentially smoked single inhalations of 25 mg of cannabis (0, 2.5, 6.0, 9.5% THC) via a pipe three times a day for 5 days to assess effects on pain (Ware et al 2007) with results the authors termed “modest”: no changes were observed in acute neuropathic pain scores, and a very low number of subjects noted 30% pain relief at the end of the study (Table 1). Even after political and legal considerations, it remains extremely unlikely that crude cannabis could ever be approved by the FDA as a prescription medicine as outlined in the FDA Botanical Guidance document (Food and Drug Administration 2004; Russo 2006b), due to a lack of rigorous standardization of the drug, an absence of Phase III clinical trials, and pulmonary sequelae (bronchial irritation and cough) associated with smoking (Tashkin 2005). Although cannabis vaporizers reduce potentially carcinogenic polyaromatic hydrocarbons, they have not been totally eliminated by this technology (Gieringer et al 2004; Hazekamp et al 2006).
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, respectively. Under those provisions, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under 21 U.S.C. § 355 (section 505 of the FD&C Act), or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
Our bodies are thought to produce endocannabinoids by the billions every day. “We always thought the ‘runner’s high’ was due to the release of dopamine and endorphins. But now we know the euphoria is also from an endocannabinoid called anandamide,” its name derived from the Sanskrit word for bliss, says Joseph Maroon, M.D., clinical professor and vice chairman of neurosurgery at the University of Pittsburgh Medical Center. We produce these natural chemicals all day, but they fade quickly because enzymes pop up to destroy them. That’s where CBD comes in: By blocking these enzymes, CBD allows the beneficial compounds to linger. This is why Amanda Oliver, 31, a career consultant in Charleston, SC, pops a CBD gummy bear each night before bed. “I used to lie there tossing and turning as my mind raced from work projects to whether I had set the home alarm,” Oliver says. One piece of candy with 15 mg of CBD is enough to shut off her brain and facilitate sleep. She also swears by the CBD oil she takes at the height of her period, which she says quells her debilitating cramps.
Some CBD oil brands can be evasive when it comes to product testing details. Populum addresses this by including a hard copy of the oil’s lab testing results in the product packaging. Full lab results are easily accessible on the brand’s website, as well. Prices for the Populum CBD oil range from 18 to 24 cents per milligram, depending on the container size, making it a relatively inexpensive full spectrum product. All U.S. military veterans receive a 25% discount, as well. Populum offers a risk-free 30-night product trial.
Given the opioid crisis, physicians are less likely to lead with narcotics, and some of us are deciding not to prescribe them altogether. The problem with narcotics is that they work. They work really well. Sometimes too well, leading to a patient becoming so comfortable they “forget” to breathe. So, while reducing the amount of narcotics prescribed to patients is a good thing, the problem is physicians don’t have a lot of good alternatives to recommend to their patients, until now.
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One of the main benefits of using CBD for pain relief is the fact that it doesn’t cause the same dependency that people get from using pharmaceutical pain medication. People have been looking into alternative pain medication for a long time – in fact plant-based treatments such as turmeric and frankincense have been used for a long time as natural therapies for pain. Cannabidiol is one such treatment that has a long history as a pain medication. Only recently the medical sector has acknowledged its use as a legitimate treatment for a variety of ailments including chronic pain.
In fact, CBD is therapeutic in nature, and will work to manipulate bodily systems at the cellular level to return afflicted organ systems, tissue systems, and even chemical systems in the central nervous system back to a state of health and homeostasis. This is precisely why it has been capable of treating conditions such as depression and anxiety, to chronic physical ailments such as pain, inflammation, arthritis, and more.
Ajulemic acid (CT3, IP-751) (Figure 1), another synthetic dimethylheptyl analogue, was employed in a Phase II RCT in 21 subjects with improvement in peripheral neuropathic pain (Karst et al 2003) (Table 1). Part of its analgesic activity may relate to binding to intracellular peroxisome proliferator-activator receptor gamma (Liu et al 2003). Peak plasma concentrations have generally been attained in 1–2 hours, but with delays up to 4–5 hours is some subjects (Karst et al 2003). Debate surrounds the degree of psychoactivity associated with the drug (Dyson et al 2005). Current research is confined to the indication of interstitial cystitis.