Sleep and Dreams // Category

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14 Jun

Evidence that taking opioids will help people with chronic pain to sleep better is limited and of poor quality, according to an interdisciplinary team of psychologists and medics from the University of Warwick in partnership with Lausanne University Hospital, Switzerland.

Many people suffering from long-term chronic pain use opioids as a sleep aid to take away pain and stop their sleep being disrupted. However, a new study led by the Department of Psychology at the University of Warwick with Warwick Medical School suggests that not enough research has been done to assess the benefits and risks of using painkillers for the purpose of improving sleep quality.

Their study, a systematic review of existing research on the effects of opioids on sleep, has been published in Sleep Medicine Reviews.

Sleep disruption is a particularly frequent issue for patients with chronic pain, with a vicious cycle building between bad nights and increased pain. Patients with chronic pain are often empirically prescribed opioids to reduce their pain enough to get a good night’s sleep, but there has been little investigation of whether this is a safe and effective intervention.

The researchers conducted a comprehensive systematic review of existing literature that examined the effects of opioids on sleep quality. As part of this, they conducted a meta-analysis of data from these studies, combining the results of 18 studies which were then narrowed down to 5 with comparable data.

They found that research on opioid effects on sleep quality was limited and of poor quality, often with potential publication bias and conflicts of interest, and rarely testing patients for sleep apnea prior to and during the study.

Patients reported a small improvement in sleep quality when using opioids but that was not consistent with results derived from sleep assessment technologies, such as the total time and the percentage of time in deep sleep, which did not show an improvement.

Certain studies reported calmer sleep with less movement but the examined articles frequently did not examine the wider effects of opioid therapy such as subsequent functioning during the day. Where they did, reports of sedation and daytime sleepiness were very frequent.

Opioids are known to affect the brain mechanism that controls breathing. This can potentially create sleep apnea events where individuals experience pauses or obstructions in breathing, like a choking sensation, resulting in snoring, gasping for air, dry mouth, and even a headache in the morning. Insomnia is known to be 42% more likely among people with chronic pain prescribed opioids than controls without opioids.

Despite this, there was some evidence that low-medium dosed opioids could help improve sleep quality in some patients in the short term, but the effect was small and requires more investigation. For those prescribed a high dose of opioid therapy it didn’t necessarily bring out better results.

The researchers are calling for better quality research into the effects of painkillers on sleep quality, as well as better information for patients from clinicians when considering opioid therapy.

Lead author Dr Nicole Tang, from the University’s Department of Psychology, says in a release, “The way people experience sleep could be quite different from what you get from physiological measurements. It is not uncommon for patients to report an improvement in their sleep quality when the severity of sleep disordered breathing has increased and without significant changes in important parameters reflecting deeper and more restorative sleep. This phenomenon is perplexing, and may reflect the inherent challenge in reconciling a wide range of ambiguous bodily information to make a categorical judgement whether sleep has improved or not after opioid therapy.”

Concerns have been growing about prescriptions of opioids, which are increasing in the UK. Dr Harbinder Sandhu from Warwick Medical School, a coauthor of the study, is leading a large clinical trial to support those with chronic pain to reduce their use of strong painkillers and manage their pain using non pharmacological alternatives. The NIHR-funded I-WOTCH (Improving the Wellbeing of People with Opioid Treated Chronic Pain) project is also collecting data on sleep quality. She says, “The benefits of opioids on managing chronic pain in the short term is well-evidenced. But we have not seen long-term benefits in managing pain and the effect on sleep is unknown, results of the study will help to inform future interventions in opioid pain management. Anyone who has concerns about opioid therapy should talk to their GP. ”

Berna Ozdemir, MD, PhD, a pain physician practicing at the Lausanne University Hospital, says, “Decisions regarding introducing or maintain long term opioid therapy are based on balancing risks and benefits with the patient suffering from chronic pain. Given that side effects and risks are sometimes not clear to patients, assessing vigilance as well as sleep both subjectively and with overnight objective measures before and after introducing opioids can be useful.”

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14 Jun

New research indicates that for treating insomnia, stimulus control therapy (which reassociates the bed with sleepiness instead of arousal) and sleep restriction therapy are effective, and it is best to use them individually rather than together.

The Worldviews on Evidence-Based Nursing study, which included 517 individuals with chronic insomnia, also found that a strategy focused only on sleep education and hygiene was minimally effective.

“Additional research is needed to further examine the effects of individual and combined therapies,” the authors wrote.

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14 Jun

SleepScore Labs—a joint venture between ResMed, Dr Mehmet Oz, and Pegasus Capital Advisors LP—has launched a “Sleep For Success” incentive program, which pays employees to improve their sleep. SleepScore Labs is leading by example in providing compensation for each night employees track their sleep with the SleepScore App and offering shortened work days if 90% participation in the program is achieved.

SleepScore Labs has documented and studied millions of nights of sleep data and understands the importance of sleep and its direct effects on productivity, creativity, and mental health stability in the workplace. As part of the “Sleep For Success” program, employees are provided access to SleepScore Premium within the app and for every night an employee tracks their sleep, they are awarded one dollar in compensation, the potential for shorter work days if team goals are met, plus additional prizes for highest average SleepScore and most sleep improvement over time.

“Our ‘Sleep For Success’ initiative allows us to practice what we preach and reward our employees by doing something that is so crucial to the mission of SleepScore Labs – sleep,” says Colin Lawler, CEO of SleepScore Labs, in a release. “We’re really putting our money where our mouth is and are excited to support our team members by taking their wellbeing seriously. Our goal is to serve as an example for other companies by showing what a solid foundation of sleep can do to impact productivity, employee happiness and health.”

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13 Jun

A simple tweak to the sleeping patterns of “night owls”—people with extreme late sleeping and waking habits—could lead to significant improvements in sleep/wake timings, improved performance in the mornings, better eating habits, and a decrease in depression and stress.

New international research by the Universities of Birmingham and Surrey in the United Kingdom and Monash University in Australia showed that over a 3-week period it was possible to shift the circadian rhythm of “night owls” using non-pharmacological and practical interventions.

The study, published in Sleep Medicine, showed participants were able to bring forward their sleep/wake timings by two hours, while having no negative effect on sleep duration. In addition, participants reported a decrease in feelings of depression and stress, as well as in daytime sleepiness.

“Our research findings highlight the ability of a simple non-pharmacological intervention to phase advance ‘night owls’, reduce negative elements of mental health and sleepiness, as well as manipulate peak performance times in the real world,” says lead researcher Elise Facer-Childs, PhD, from Monash University’s Turner Institute for Brain and Mental Health, in a release.

“Night owls” are individuals whose internal body clock dictates later-than-usual sleep and wake times; in this study participants had an average bedtime of 2.30 am and wake-up time of 10.15 am.

Disturbances to the sleep/wake system have been linked to a variety of health issues, including mood swings, increased morbidity and mortality rates, and declines in cognitive and physical performance.

“Having a late sleep pattern puts you at odds with the standard societal days, which can lead to a range of adverse outcomes—from daytime sleepiness to poorer mental wellbeing,” says study coauthor Andrew Bagshaw, MSc, PhD, from the University of Birmingham.

“We wanted to see if there were simple things people could do at home to solve this issue. This was successful, on average allowing people to get to sleep and wake up around two hours earlier than they were before. Most interestingly, this was also associated with improvements in mental well-being and perceived sleepiness, meaning that it was a very positive outcome for the participants. We now need to understand how habitual sleep patterns are related to the brain, how this links with mental well-being and whether the interventions lead to long-term changes.”

Twenty-two healthy individuals participated in the study. For a period of 3 weeks participants in the experimental group were asked to:

  • Wake up 2-3 hours before regular wake up time and maximize outdoor light during the mornings.
  • Go to bed 2-3 hours before habitual bedtime and limit light exposure in the evening.
  • Keep sleep/wake times fixed on both work days and free days.
  • Have breakfast as soon as possible after waking up, eat lunch at the same time each day, and refrain from eating dinner after 7pm.

The results highlighted an increase in cognitive (reaction time) and physical (grip strength) performance during the morning when tiredness is often very high in night owls, as well as a shift in peak performance times from evening to afternoon. It also increased the number of days in which breakfast was consumed and led to better mental well-being, with participants reporting a decrease in feelings of stress and depression.

“Establishing simple routines could help night owls adjust their body clocks and improve their overall physical and mental health. Insufficient levels of sleep and circadian misalignment can disrupt many bodily processes putting us at increased risk of cardiovascular disease, cancer and diabetes,” says Debra Skene, MSc, PhD, a professor from the University of Surrey.

Facer-Childs says night owls, compared to “morning larks,” tended to be more compromised in our society due to having to fit to work/school schedules that are out of sync with their preferred patterns.

“By acknowledging these differences and providing tools to improve outcomes we can go a long way in a society that is under constant pressure to achieve optimal productivity and performance,” she says.

This intervention could also be applied within more niche settings, such as industry or within sporting sectors, which have a key focus on developing strategies to maximize productivity and optimize performance at certain times and in different conditions.

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13 Jun

New research from the University of British Columbia (UBC) suggests there are more benefits to a good night’s sleep than simply feeling refreshed.

“Chronic, low-quality sleep was associated with poorer health outcomes among young [British Columbia] students,” says study author Annalijn Conklin, MSc, MPH, PhD , assistant professor of pharmaceutical sciences at UBC and a scientist with the Centre for Health Evaluations and Outcome Sciences, in a release. “Kids who regularly had trouble falling or staying asleep were almost two and half times as likely to report suboptimal or less than excellent health, compared to those who did not.”

The study, published in Preventive Medicine, looked at 3,104 students in British Columbia aged 13 to 17 over a period of two years.

“Even if these teens had difficulty falling asleep just one night a week, if that was a regular occurrence over two years, it really seemed to affect their overall health,” Conklin says. “What was particularly interesting was that the relationship between chronic, poor-quality sleep and health outcome was stronger in the boys than it was in the girls.”

However, the research found no relationship between poor health outcomes and those who chronically had less than 8 hours sleep a night.

As an observational study, this research does not look into cause and effect, but the researchers say the findings signal that cumulative sleep problems matter for the health of young people.

“It shows that there’s definitely a link between poor health and chronic poor-quality sleep, which may be gender-specific, and I’m looking forward to seeing more research explore that connection,” Conklin says.

She adds that the findings highlight the need for parents to work on the many recommendations around about sleep hygiene practices. “Other studies have specifically shown that late-night screen use and caffeine consumption have harmful consequences for falling sleep. Young people’s health may benefit from parents enforcing sleep schedules and placing restrictions on screen time,” Conklin says.

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13 Jun

A large national population of United States veterans used the same standardized tool that the general population uses for tracking health.

More than 3,000 veterans from across the country used the tool to self-report their health in the study led by a researcher from Northwestern Medicine and the US Department of Veterans Affairs. Findings showed that veterans scored worse in several areas, including feeling more anxiety, depression, fatigue, sleep disturbance, and pain compared to people in the general population.

These self-reported outcomes were valid because they matched physician diagnoses documented in medical records, the study says.

The study’s scientists believe patient self-reporting will be a successful way to track the health of veterans, who may be hesitant to seek medical care.

The self-reporting tool—a survey called PROMIS-29—is commonly used in the general population but not widely or systematically offered to veterans. The scientists mailed the survey to veterans for this study, which is the first to report PROMIS-29’s use in a large national cohort of veterans.

“These are our nation’s veterans. They served our country, and they deserve access to things made available to everyone,” says lead author Sherri LaVela, PhD, MPH, a research associate professor of physical medicine and rehabilitation at Northwestern University Feinberg School of Medicine and a department of veterans affairs scientist, in a release. “The PROMIS instrument is being used more and more for health care, and we hope to see it integrated into veteran care as well.”

The instrument used in the study may be a useful tool for health care providers to assess veteran patient’s physical and mental health, as indicated by the positive associations between scores and clinical documentation which suggests clinical validity for targeted measures, LaVela says.

The study was published in the Journal of General Internal Medicine.

The VA serves more than 8.3 million veterans in the United States annually.

“Seeing how veterans fare relative to population norms is important because it gives us a fuller picture of their health and allows us a cursory glance at how they are doing in general,” LaVela says. “Estimates like this are important because they provide normal ranges for health measures across cohorts. Veterans have enhanced options of seeking care outside the VA, which makes it crucial to have an accurate measurement of health status and symptoms among population-based samples. Being able to simply, yet effectively, collect these data will identify unmet needs in which to intervene.”

Patients using PROMIS-29 answered a short series of questions about their health and quality of life. The survey is scored to indicate if they are experiencing disturbed sleep, anxiety, depression or pain, for instance. Given the responses, the patient and their health care team can follow up and schedule a doctor’s appointment.

“If a veteran has poor scores, we want to get them in and take a look,” LaVela says.

Veterans in the study also scored lower for physical function than civilians and lower for satisfaction with social role, such as being satisfied with their ability to work, do regular personal and household responsibilities, and perform daily routines.

Patient-reported data can be used to inform health care providers about symptoms, perceived state of health and are especially important to understand patient experiences among people with chronic diseases.

The ability to quickly and easily identify health disparities in veterans is important because it can prompt health care providers to intervene. For example, the study finds that relative to general population norms, veterans reported worse scores for pain interference. The VA has been integrating innovative, patient-centric approaches ways into treatment options. Using pain as an example, the VA has a stepped-care pain management approach that can be used for intervention, and recently the VA implemented mindfulness types of interventions to help veterans with pain, post-traumatic stress disorder, and other conditions that may afflict veterans, LaVela says.

Former Marine Dustin Lange says seeing how a veteran’s health stacks up against the general population can serve as much-needed motivation for a veteran to go see the doctor.

“A lot of times, veterans might be hesitant to go to the hospital or not get proper checkups,” says Lange, a U.S. Veteran who spent eight years in the Marines and is now the associate director of the Chez Center for Wounded Veterans in Higher Education at University of Illinois, Urbana-Champaign.

Lange has taken the PROMIS-29 survey, though not for this study. His score indicated some disturbances in his sleep, which prompted him to schedule a doctor’s appointment. His clinical checkup validated his PROMIS-29 results. Lange says he hopes PROMIS-29 becomes more widely available for veterans, because he thinks it could motivate veterans to see a doctor.

“As a vet, you’re able to see, ‘Am I having similar problems to the general population? Do I have higher sleep or pain problems?” Lange says. “Seeing that difference from the general population could prompt a vet to visit the VA and get help.”

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12 Jun

Preliminary findings from two analyses of an ongoing study suggest that cognitive behavioral therapy for insomnia (CBT-I) delivered by telemedicine is as effective as face-to-face delivery.

Results of a randomized controlled non-inferiority trial show that both delivery methods were equally effective at improving sleep outcomes measured by sleep diaries, reducing self-reported sleep latency and wake after sleep onset, while increasing total sleep time and sleep efficiency. There also were no differences between the two delivery methods in patient perception of therapeutic alliance, warmth, and confidence in the therapist’s skills.

“The most surprising findings in the study were that, contrary to our hypotheses, participants who received CBT for insomnia via telemedicine rated therapist alliance similarly to participants who received face-to-face CBT for insomnia,” says principal investigator J. Todd Arnedt, PhD, an associate professor of psychiatry and neurology and co-director of the Sleep and Circadian Research Laboratory at Michigan Medicine, University of Michigan in Ann Arbor, in a release. “In addition, ratings of satisfaction with treatment were equivalent between face-to-face and telemedicine participants. Relative to other remote modalities, telemedicine may offer a unique blend of convenience for the patient while preserving fidelity of the face-to-face interaction.”

The analysis comparing sleep and daytime functioning variables included 47 adults with chronic insomnia, including 33 women. The analysis of therapeutic alliance involved 38 adults with insomnia, including 25 women. Participants had a mean age of about 52 years. They were randomized to six sessions of CBT-I delivered face-to-face or via the AASM SleepTM telemedicine system. One therapist delivered CBT-I in both conditions.

“Preliminary findings from this study suggest that patients undergoing telemedicine for insomnia can feel just as close and supported by their therapist as if they were in the office,” says co-investigator Deirdre Conroy, PhD, a clinical associate professor of psychiatry and clinical director of the Behavioral Sleep Medicine Program at Michigan Medicine, University of Michigan in Ann Arbor. “Telemedicine could be utilized more for CBT-I to bridge the gap between supply and demand for this service.”

Both research abstracts were published recently in an online supplement of the journal Sleep and were presented Monday, June 10, in San Antonio at SLEEP 2019.

The study was supported by funding from the American Academy of Sleep Medicine Foundation.

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12 Jun

Sleeping with a television or light on in the room may be a risk factor for gaining weight or developing obesity, according to scientists at the National Institutes of Health. The research, which was published online June 10 in JAMA Internal Medicine, is the first to find an association between any exposure to artificial light at night while sleeping and weight gain in women. The results suggest that cutting off lights at bedtime could reduce women’s chances of becoming obese.

The research team used questionnaire data from 43,722 women in the Sister Study, a cohort study that examines risk factors for breast cancer and other diseases. The participants, aged 35-74 years, had no history of cancer or cardiovascular disease and were not shift workers, daytime sleepers, or pregnant when the study began. The study questionnaire asked whether the women slept with no light, a small nightlight, light outside of the room, or a light or television on in the room.

The scientists used weight, height, waist and hip circumference, and body mass index measurements taken at baseline, as well as self-reported information on weight at baseline and follow-up five years later. Using this information, the scientists were able to study obesity and weight gain in women exposed to artificial light at night with women who reported sleeping in dark rooms.

The results varied with the level of artificial light at night exposure. For example, using a small nightlight was not associated with weight gain, whereas women who slept with a light or television on were 17% more likely to have gained 5 kilograms, approximately 11 pounds, or more over the follow-up period. The association with having light coming from outside the room was more modest.

Also, the scientists wondered if not getting enough rest factored into the findings.

“Although poor sleep by itself was associated with obesity and weight gain, it did not explain the associations between exposure to artificial light while sleeping and weight,” says corresponding author Dale Sandler, PhD, chief of the Epidemiology Branch at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, in a release.

Co-author Chandra Jackson, PhD, head of the NIEHS Social and Environmental Determinants of Health Equity Group, is interested in racial disparities in sleep health. She notes that for many who live in urban environments, light at night is more common and should be considered. Streetlights, store front neon signs, and other light sources can suppress the sleep hormone melatonin and the natural 24-hour light-dark cycle of circadian rhythms.

“Humans are genetically adapted to a natural environment consisting of sunlight during the day and darkness at night,” Jackson says. “Exposure to artificial light at night may alter hormones and other biological processes in ways that raise the risk of health conditions like obesity.”

The authors acknowledge that other confounding factors could explain the associations between artificial light at night and weight gain. However, their findings did not change when analyses controlled for characteristics that may be associated with exposure to light at night. These factors included age, having an older spouse or children in the home, race, socioeconomic status, calories consumed, and physical activity. Also, the study did not include men.

Lead author Yong-Moon (Mark) Park, MD, PhD, is a postdoctoral fellow in Sandler’s group. He says the research suggests a viable public health strategy to reduce obesity incidence in women.

“Unhealthy high-calorie diet and sedentary behaviors have been the most commonly cited factors to explain the continuing rise in obesity,” Park says. “This study highlights the importance of artificial light at night and gives women who sleep with lights or the television on a way to improve their health.”

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12 Jun

A bad night’s sleep may result in a spike in blood pressure that night and the following day, according to new research led by the University of Arizona.

The study, to be published in the journal Psychosomatic Medicine, offers one possible explanation for why sleep problems have been shown to increase the risk of heart attack, stroke, and even death from cardiovascular disease.

The link between poor sleep and cardiovascular health problems is increasingly well-established in scientific literature, but the reason for the relationship is less understood.

Researchers set out to learn more about the connection in a study of 300 men and women, ages 21 to 70, with no history of heart problems. Participants wore portable blood pressure cuffs for two consecutive days. The cuffs randomly took participants’ blood pressure during 45-minute intervals throughout each day and also overnight.

At night, participants wore actigraphy monitors to help determine their “sleep efficiency,” or the amount of time in bed spent sleeping soundly.

Overall, those who had lower sleep efficiency showed an increase in blood pressure during that restless night. They also had higher systolic blood pressure the next day.

More research is needed to understand why poor sleep raises blood pressure and what it could mean long-term for people with chronic sleep issues. Yet, these latest findings may be an important piece of the puzzle when it comes to understanding the pathway through which sleep impacts overall cardiovascular health.

“Blood pressure is one of the best predictors of cardiovascular health,” says lead study author Caroline Doyle, a graduate student in the UA Department of Psychology, in a release. “There is a lot of literature out there that shows sleep has some kind of impact on mortality and on cardiovascular disease, which is the No. 1 killer of people in the country. We wanted to see if we could try to get a piece of that story—how sleep might be impacting disease through blood pressure.”

The study reinforces just how important a good night’s sleep can be. It’s not just the amount of time you spend in bed, but the quality of sleep you’re getting, says study co-author John Ruiz, UA associate professor of psychology.

Improving sleep quality can start with making simple changes and being proactive, Ruiz said.

“Keep the phone in a different room,” he suggested. “If your bedroom window faces the east, pull the shades. For anything that’s going to cause you to waken, think ahead about what you can do to mitigate those effects.”

For those with chronic sleep troubles, Doyle advocates cognitive behavioral therapy for insomnia (or CBT-I), which focuses on making behavioral changes to improve sleep health.

Doyle and Ruiz say they hope their findings—showing the impact even one fitful night’s rest can have on the body—will help illuminate just how critical sleep is for heart health.

“This study stands on the shoulders of a broad literature looking at sleep and cardiovascular health,” Doyle says. “This is one more study that shows something is going on with sleep and our heart health. Sleep is important, so whatever you can do to improve your sleep, it’s worth prioritizing.”

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11 Jun

Cannabinoid products company Spectrum Therapeutics, the medical division of Canopy Growth Corp, shares an update on its efforts to develop and commercialize validated cannabis medicines through clinical trials.Spectrum Therapeutics is pursuing research to introduce products for the therapeutic areas of pain, mood, and sleep and to gain access to new markets independent of medical cannabis laws.

Clinical Research

Spectrum Therapeutics is focused over the next 24 months to further the science of cannabinoids and provide evidence by way of clinical trials on what conditions medical cannabis can treat. This research includes product design and ingredient selection, formulation, and safety and efficacy testing towards the development of standardized cannabis drug formulations and dose delivery systems. Research activity is occurring in two main areas: registration trials and exploratory studies.

Registration trials begin with phase I studies of cannabinoid products covering a spectrum of proprietary THC and CBD ratios. These initial trials provide critical dosing and safety data to inform subsequent phase II trials. Two phase I trials have already been completed (in Canada and Chile).

Exploratory “proof of concept” studies use a range of Spectrum products and design methodologies to explore different dose responses, and safety and efficacy signals for target conditions. Those that show promising results will be added to the registration trial pipeline and their initial findings will allow for optimal phase II trial design. The first proof of concept phase IIb “in human” clinical trial previously announced by the company, to evaluate the use of medical cannabis for treating insomnia, is in progress in partnership with Drs Julie Carrier and Alex Desautels at the Université de Montréal. It is expected to be completed by calendar Q2 2020 with results announced by calendar Q3 2020.

Other proof of concept studies are currently underway in partnership with researchers including Dr Bernard Le Foll at the Centre for Addiction and Mental Health, Dr Mary-Ann Fitzcharles at McGill University, and Dr Angela Genge at the Montreal Neurological Institute. Over 20 conditions are being examined across these studies, including pain, sleep, and mood/anxiety disorders. Spectrum Therapeutics is also exploring areas such as neurodegenerative disorders, in addition to a previously announced research partnership with NEEKA Health Canada and the NHL Alumni Association which is examining the efficacy of CBD-based therapies as part of a treatment for concussion symptoms. This clinical trial is expected to register its first patients by October 2019 with preliminary results by July 2020.

Recently acquired C3 Cannabinoid Compound Company is currently progressing a clinical trial for the use of dronabinol to treat spasticity due to multiple sclerosis. Additionally, research on the potential of medical cannabis to treat cancer-related pain is also in the works with Beckley Canopy Therapeutics, a partnership established between UK drug research institute, The Beckley Foundation, and Canopy Growth. Patient registrations for this trial are expected in September 2019.

Pharmacovigilance

Spectrum Therapeutics has also implemented a global pharmacovigilance program to capture and document adverse events reported from the worldwide use of its medical cannabis products in addition to the company’s Canadian recreational cannabis brands including Tweed and DNA Genetics, and its CBD product offerings.

Pharmacovigilance, also known as drug safety, is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects from the use of pharmaceutical products. While Spectrum Therapeutics and Canopy Growth were already reporting any adverse reactions to its cannabis products as per Health Canada regulations, the launch of this global pharmacovigilance program ensures that all employees are trained on how to identify and report adverse events. The company’s internal Pharmacovigilance team is responsible for analyzing and entering events into a global safety database compliant with regional regulatory requirements.

A global independent safety monitoring board chaired by Yola Moride, a professor at the Université de Montréal, will periodically review adverse event summaries and advise the Spectrum Therapeutics scientific team regarding product safety and clinical trial design.

“We believe that this strategic approach to global clinical research, in collaboration with outstanding investigators and institutions, and supported by our first-rate team of scientists, will generate innovative products for a number of indications with significant unmet needs,” says Dr Mark Ware, chief medical officer, Canopy Growth. “We are also pleased to announce the launch of our global pharmacovigilance program whereby every one of our 3,000+ staff worldwide are trained in reporting adverse events. It’s an important step towards establishing drug safety and will advance our efforts to provide patients with accepted, clinically validated cannabis medicines while transparently demonstrating the relative risks of cannabis.”

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