Several research studies are underway as Organic Remedies partners with the Philadelphia College of Osteopathic Medicine. Researchers at PCOM are looking to answer important questions about the therapeutic value of medical marijuana in several key areas.
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As a clinical registrant in Pennsylvania, Organic Remedies has embedded researchers in four of its dispensary locations and is assisting with the recruitment of patients to participate in the research. Organic Remedies also provides the products used by patients who are participating in the research.
Determining Psychological, Social, and Clinical Outcomes with the Use of Medical Marijuana
Organic Remedies and PCOM started recruiting for the first of several clinical studies in the fall of 2020. The study focuses on health-related quality of life for patients starting medical marijuana treatment for one or more of the state-approved 24 qualifying conditions. More than four hundred patients with no previous experience with medical marijuana have enrolled to participate; a majority are looking for treatment for chronic pain and/or anxiety. Early recruiting was a challenge because of COVID-19 protocols, but Organic Remedies staff met the challenge and referred patients to the embedded researcher for screening.
The study focuses on how an individual’s life may change over time when using medical marijuana, clinically, psychosocially, as well as their quality of life. Researchers are looking for answers as to how an individual’s life changes with medical marijuana use, not only in terms of the severity of their relevant health condition, but also their health-related quality of life, including social functioning, daily activities, work life, and interpersonal relationships. Interviews with participants are conducted every three months over the course of one year.
While the data are still being analyzed from this study, one paper has been published in the journal of Medical Cannabis and Cannabinoids. This paper, Clinical Characteristics and Quality of Life in Adults Initiating Medical Marijuana Treatment, describes the demographic characteristics and health-related quality of life of medical marijuana patients who are initiating treatment in Pennsylvania.
Weight Change in Medical Marijuana Patients
Following this first study, a second paper was published in the Journal of Cannabis Research. The study looked at a sub-sample of participants with obesity to determine if individuals experienced weight change as a result of medical marijuana consumption.
The study found that in the first three months, there was no significant change in weight for individuals just starting a medical marijuana regimen.
Michelle Lent, PhD
“This finding is significant because it will inform patient-provider conversations about medical marijuana, and providers can refer to these data to address patient concerns about possible weight gain or loss when considering medical marijuana as part of their treatment plan,”
said Michelle Lent, PhD., PCOM director of psychosocial research for medical marijuana and associate professor, school of professional and applied psychology.
Medical Marijuana as a Treatment for Chronic Pain in Patients Living with Opioid Use Disorder
Recruiting participants for a study focused on the incremental effects of medical marijuana on pain management and treatment engagement in patients with opioid use disorder and chronic pain was initiated in April 2022. Many people with opioid use disorder also live with severe pain, which may be one of the reasons they started using opioids. Researchers are looking to recruit 120 adults with chronic pain and opioid use disorder in the Philadelphia area. The study will examine additional qualities of the individuals' lives, including sleep, mood, and other substances they are using.
Individuals selected must already have a recommendation from their provider to use medical marijuana and be taking Suboxone, a prescription medication for treating opioid use disorder.
PCOM is working with Ethos, a dispensary in Center City Philadelphia, so that participants can conveniently pick up their medical marijuana medication.
Dr. Lent said, “We believe this may be one of our most important studies to date, given the opioid epidemic and the limited treatments currently available to help those with opioid use disorder.”
Medical Marijuana as a Treatment for Autism
Elizabeth Gosch, PhD
Another research study initiated in July 2022 may bring to light new information about the therapeutic effects of medical marijuana for the treatment of pediatric autism. Dr. Lent is collaborating with Elizabeth Gosch, PhD., a licensed clinical psychologist, certified by the American Board of Clinical Child and Adolescent Psychology who serves as an examiner for this board. Dr. Gosch is a nationally recognized expert on clinical child psychology, anxiety disorders, and cognitive behavior therapy with youth.
Researchers have started to recruit for 50 adult caregivers of pediatric patients with autism who are looking to start a medical marijuana regimen.
The study will focus on specific autism behaviors, including repetition, aggression, cognition, sleep activity, and independence. The study will examine behaviors before beginning a medical marijuana regimen, and then assess any changes to behaviors periodically throughout the study. All measures will be calibrated based on what would be appropriate for the child’s age.
“We are very excited about this small pilot study and hope that these results will be of benefit to individuals with autism as well as their providers and caregivers,” said Dr. Lent.
For more information or to enroll in this study, email AutismStudy@pcom.edu.
Other Research Studies Approved
Frederick J. Goldstein, PhD
Frederick J. Goldstein, Ph.D., FCP, Professor of Clinical Pharmacology, PCOM and his team are currently recruiting for two studies.
“We are just beginning to explore at a scientific level the pain-relieving qualities of THC. Organic Remedies’ continued support that allows us to work within the dispensaries to recruit patients, along with the financial support, are greatly appreciated. Our research coordinator has an office in the Paoli dispensary, and we are confident that these studies will garner important scientific data about medical marijuana,”
said Dr. Goldstein.
Study of Nano-Emulsion Capsules Containing Vitamin E
Dr. Goldstein and his team are preparing to study the absorption of THC into the bloodstream after consuming Organic Remedies’ nano-emulsion capsules. The study is to determine how much THC gets into your blood over 24 hours after taking one capsule that contains Vitamin E, plus equal amounts of THC and CBD. The purpose of this research is to find out how the body handles a new form of medical marijuana capsule over 24 hours. In medical marijuana, there are many cannabinoids, including THC (Delta-9-tetrahydrocannabinol) and CBD (Cannabidiol). This new type of medical marijuana capsule has equal amounts of these two substances. The capsule also includes Vitamin E. Both CBD and Vitamin E may allow more marijuana to be absorbed into the bloodstream than by taking THC by itself. Scientists want to learn how much THC enters the bloodstream during the 24 hours after the capsule has been swallowed.
Relief of Nerve Pain with Medical Marijuana
Another study led by Dr. Goldstein is focused on patients who suffer from neuropathic pain. He is looking to determine what connection, if any, there is between the use of medical marijuana and the relief of nerve pain that has been occurring daily for at least two months. This 4-week study will require patients with neuropathic pain to consume a THC-CBD combination product. Enrollment in the study has recently started; one participant has now successfully completed the study with a reduction in pain and a decrease in both sleep medicine and an aspirin-like drug; there was also a loss of weight which was related to an increase in physical activity. Two additional participants are beginning to use this product, and another is considering participation. “This study will add significant scientific data around medical marijuana and pain management,” said Dr. Goldstein. “There are hundreds of thousands of individuals suffering with nerve pain on a daily basis who may benefit from this study. We are excited to learn more and further our understanding of consumption of THC-CBD as related to neuropathic pain.” Use of Medical Cannabis in Nursing Homes in Pennsylvania
Dr. Katherine E. Galluzzi, D.O., and her team are evaluating the current state of usage of medical marijuana in Skilled Nursing Facilities in Pennsylvania. An anonymous survey was sent to the Nursing Home Administrator or Director of Nursing requesting information about existing policies for the use of medical marijuana in their facility. The goal of the study is to determine the extent of use of medical marijuana in different geographic areas across PA and identify barriers to use for residents with qualifying conditions.
Effectiveness of Solvent-Based Extraction Methods and Processes to Eliminate or Substantially Diminish Microbial Contamination of Marijuana Plant Extract
Brian Balin, Ph.D., collaborated with the team of scientists at Organic Remedies led by Mark June Wells, Ph.D., to determine whether the solvent extraction process eliminates microbial contaminants from marijuana plant material, and whether the manufacturing process creates raw extracted materials that conform to current PA DOH regulations for safe consumption by patients. This research and independent testing demonstrating that all extracted materials were free of microbial contaminants and associated toxins were recently published in the journal Cannabis Science and Technology, Vol. 5, No. 9 [June-Wells et al, 2022) (Cannabissciencetech.com).
Conclusion
Organic Remedies is proud to be working with the Philadelphia College of Osteopathic Medicine on these important studies on the medicinal value of medical marijuana.
“We believe our research will inform patient-provider decisions on whether to use medical marijuana to treat specific conditions. We'll be creating a body of literature to inform medical professionals. It's very exciting to be able to fill a gap in our knowledge of the therapeutic value of medical marijuana for a variety of conditions. The preliminary data we are seeing looks promising,”
said Dr. Lent.
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