A randomized trial of medical cannabis in patients with stage IV cancers to assess feasibility, dose requirements, impact on pain and opioid use, safety, and overall patient satisfaction.

PURPOSE: The prevalence of medical cannabis (MC) use in patients with cancer is growing, but questions about safety, efficacy, and dosing remain. Conducting randomized, controlled trials (RCTs) using state-sponsored MC programs is novel and could provide data needed to guide patients and providers. METHODS: A pilot RCT of patients with stage IV cancer requiring opioids was conducted. Thirty patients were randomized 1:1 to early cannabis (EC, n = 15) versus delayed start cannabis (DC, n = 15). The EC group obtained 3 months (3 M) of MC through a state program at no charge, while the DC group received standard oncology care without MC for the first 3 M. Patients met with licensed pharmacists at one of two MC dispensaries to determine a suggested MC dosing, formulation, and route. Patients completed surveys on pain levels, opioid/MC use, side effects, and overall satisfaction with the study. RESULTS: Interest in the study was high as 36% of patients who met eligibility criteria ultimately enrolled. The estimated mean daily THC and CBD allotments at 3 M were 34 mg and 17 mg, respectively. A higher proportion of EC patients achieved a reduction in opioid use and improved pain control. No serious safety issues were reported, and patients reported high satisfaction. CONCLUSION: Conducting RCTs using a state cannabis program is feasible. The addition of MC to standard oncology care was well-tolerated and may lead to improved pain control and lower opioid requirements. Conducting larger RCTs with MC in state-sponsored programs may guide oncology providers on how to safely and effectively incorporate MC for interested patients.

Impact of Medical Cannabis on Patient-Reported Symptoms for Patients With Cancer Enrolled in Minnesota's Medical Cannabis Program.

PURPOSE: Minnesota's medical cannabis program is unique, in that it routinely collects patient-reported scores on symptoms. This article focuses on changes in symptom severity reported by patients with cancer during their first 4 months of program participation. MATERIALS AND METHODS: Patients with cancer in Minnesota's medical cannabis program reported symptoms (anxiety, lack of appetite, depression, disturbed sleep, fatigue, nausea, pain, and vomiting) at their worst over the last 24 hours before each medical cannabis purchase. Baseline scores on each of the eight symptoms were statistically compared with the average symptom scores reported in the first 4 months of program participation. Symptom scores were also calculated as percent change from baseline, with patients achieving and maintaining at least a 30% reduction in symptoms reported in this article. Patients also reported intensity of adverse effects. RESULTS: A significant reduction in scores was found across all symptoms when comparing baseline scores with the average score submitted within the first 4 months of program participation (all Ps < .001). The proportion of patients achieving 30% or greater symptom reduction within the first 4 months of program participation varied from 27% (fatigue) to 50% (vomiting), with a smaller proportion both achieving and maintaining those improvements. Adverse effects were reported in a small proportion of patients (10.5%). CONCLUSION: Patients with cancer enrolled in Minnesota's medical cannabis program showed significant reduction across all eight symptoms assessed within 4 months of program participation. Medical cannabis was well tolerated, and some patients attained clinically meaningful and lasting levels of improvement.

A Comprehensive Review of Cannabis in Patients with Cancer: Availability in the USA, General Efficacy, and Safety.

PURPOSE OF REVIEW: As the legalization of medical cannabis continues across the USA, oncology care providers will be increasingly asked to provide recommendations regarding its use in the cancer setting. In this article, we review recent literature that analyzes cannabis use specifically in patients with cancer and provide an accessible guide for clinicians, researchers, and patients. RECENT FINDINGS: We aimed to answer questions about the availability of cannabis in the USA, the trials supporting its use in the cancer setting, and the important factors to consider related to safety. Thirty states plus the District of Columbia have established comprehensive medical cannabis programs, each with different regulations and products available. In June 2018, Epidiolex, a cannabis extraction product containing 99% CBD, was approved to treat refractory seizures; however, whole-plant products and non-prescription extraction products dominate the market. Recent randomized, placebo-controlled studies of nabiximols (Sativex) in patients with refractory cancer-pain have largely shown no significant benefits. Conversely, large observational studies suggest patients with cancer using cannabis report significant improvement of many common symptoms. Cannabis use appears well tolerated, with few serious adverse effects reported. Though prospective clinical trials are needed to provide the robust data required to establish the proper role of cannabinoid and cannabis-based therapy in cancer patients, physicians can draw upon the knowledge currently available to have informed discussions with their patients.

Oncology Clinicians and the Minnesota Medical Cannabis Program: A Survey on Medical Cannabis Practice Patterns, Barriers to Enrollment, and Educational Needs.

Background: Medical cannabis has been available in the State of Minnesota since July 2015 through the Minnesota Medical Cannabis Program (MMCP). Objectives: Our study aimed to delineate oncology providers' views on medical cannabis, identify barriers to patient enrollment, and assess clinicians' interest in a clinical trial of medical cannabis in patients with stage IV cancer. Methods: From June to August 2017, we distributed a 14-question survey to Minnesota oncology physicians, advanced practice nurses, and physician assistants who care for adults and children with cancer. Descriptive analyses for each question were provided for all survey respondents. Results: Of the 529 eligible survey participants, 153 (29%) responded to our survey; 68 respondents were registered with the MMCP. Most identified themselves as a medical oncologist or medical oncology nurse practitioner/physician assistant (n=125, 82%), and most practiced in a community setting (n=102, 67%). Overall, 65% of respondents supported the use of medical cannabis. Perceived cost and inadequate research were the highest barriers to MMCP patient enrollment. The lowest barriers included lack of health group support for allowing certification of patients and risk of social stigma. Of all respondents, 36% lacked confidence in discussing the risks and benefits of medical cannabis, and 85% wanted more education. Conclusions: Although support for cannabis use in the cancer setting is growing, significant barriers remain. This study illustrates a clear need to give clinicians both data and education to guide their discussions about the benefits, risks, and cost considerations of using medical cannabis for cancer-related symptoms.

Minnesota Pharmacists and Medical Cannabis: A Survey of Knowledge, Concerns, and Interest Prior to Program Launch.

OBJECTIVES: To assess Minnesota pharmacists' preparedness for the state's medical cannabis program in terms of professional competency in policies and regulations and in pharmacotherapy, as well as their concerns and perceptions about the impact on their practice. The secondary objective was to identify pharmacists' perceptions about ways to reduce potential gaps in knowledge. METHODS: A Web-based 14-item questionnaire was distributed to all pharmacists whose email addresses were registered with the Minnesota Board of Pharmacy. RESULTS: Pharmacists reported limited knowledge of Minnesota state-level cannabis policies and regulations and felt that they were inadequately trained in cannabis pharmacotherapy. Most pharmacists were unprepared to counsel patients on medical cannabis and had many concerns regarding its availability and usage. Only a small proportion felt that the medical cannabis program would impact their practice. Pharmacists' leading topics of interest for more education included Minnesota's regulations on the medical cannabis program, cannabis pharmacotherapy, and the types and forms of cannabis products available for commercialization. Preferred modes of receiving information were electronic-based, including email and online continuing education credit. Since the survey's completion, educational presentations have been provided to pharmacists and health professionals in Minnesota. CONCLUSION: Pharmacists need more training and education on the regulatory and clinical aspects of cannabis in preparation for their work with patients in the medical cannabis program.

Early Survey Results from the Minnesota Medical Cannabis Program.

As part of its legislative mandate, the Minnesota Department of Health's Office of Medical Cannabis (OMC) is required to study and report on the state's medical cannabis program. This article describes preliminary findings from the OMC's research about who is using the program and whether patients and their certifying health care practitioners are noticing benefits and harms.

Insights from a Review of Medical Cannabis Clinical Trials.

The Minnesota Legislature passed a law establishing a medical cannabis program in 2014. One of the first tasks of staff in the new Office of Medical Cannabis at the Minnesota Department of Health was to review scientific literature on medical cannabis. The review was limited to studies involving products similar to those allowed in Minnesota. This article explains how the review was conducted and presents three themes that emerged from it.

Behavior modification after inactivation of cerebellar dentate nuclei.

Effort-based decision making occurs when subjects are given a choice between a reward available at a high response cost and a reward available at a low response cost and is altered in individuals with disorders such as autism or particular patterns of brain injury. The current study explored the relationship between effort-based decision making and reinforcement characteristics in the T maze. This was done using both normal animals and animals with bilateral inactivation of the cerebellar dentate nuclei. Rats chose between alternatives in which one arm contained high-density reinforcement (HR) and the other arm contained low-density reinforcement (LR). During training, the HR arm was obstructed and the point at which the animal no longer worked for reinforcement (breaking point) was determined. The cerebellar dentate nuclei were then transiently inactivated and once again breaking points were assessed. The results indicated that inactivation of the dentate nucleus disrupted effort-based decision making. Additionally, altering both the palatability and the magnitude of the reinforcement were assessed in an attempt to reestablish the original preinactivation breaking point. It was hypothesized that an increase in the strength or magnitude of the reinforcement would promote an increase in the breaking point of the animal even when the cerebellum was inactivated. The results indicated that with both strategies animals effectively reestablished original breaking points. The results of this study will inform the current literature regarding the modification of behavior after brain injury and further the understanding of the behavioral deficits associated with cerebellar dysfunction.

Adopting an electronic health record. Keys to success.

Stratis Health, through its capacity as Minnesota's Medicare Quality Improvement Organization, is working to promote successful implementation of electronic health records (EHRs) in primary care clinics in the state. This article focuses on lessons learned while helping primary care clinics adopt EHRs. It also includes observations on the current status of EHR adoption in Minnesota clinics. Sixty-eight percent of 341 clinics responding to a survey have implemented, are in the process of implementing, or plan to implement electronic health record systems during the next 2 years.