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 23 qualifying conditions.  More than four hundred patients with no previous experience with medicinal marijuana have enrolled to date 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 marijuana use, not only in terms of the severity of their referred 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.

Following this first study, a second paper was published in the Journal of Cannabis Research. The study looked at a sub sample of the 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.

“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.

Recruiting participants for a second study began in April 2022. This study is focused on the incremental effect of medical marijuana on an individual's pain management and their treatment engagement for people with opioid use disorder and chronic pain. 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 for 120 adults with chronic pain and opioid use disorder in the Philadelphia area. The study will look at many facets of the individual’s life, 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 for treating opioid use disorder.

PCOM has partnered with Ethos, a dispensary in Center City Philadelphia, so that participants can conveniently pick up their medications. 

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.”

Another research study initiated in July 2022 may bring to light new information about the therapeutic effects of medical marijuana when recommended by a physician for the treatment of pediatric autism. Dr. Lent is joining forces with Elizabeth Gosch, PhD., a licensed clinical psychologist, certified by the American Board of Clinical Child and Adolescent Psychology and 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 like repetition and aggression, cognition, sleep activity and independence. The study will look at behaviors before beginning a medical marijuana regimen, and then assess any changes to behaviors periodically throughout the study. All the 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 [email protected].

Dr. Goldstein and his team are looking 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-tetrahydrocannbinol) 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 goes into the bloodstream during the 24 hours after the capsule has been swallowed.

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 relief of nerve pain that has been occurring for at least two months. The purpose of this research is to find out if medical marijuana can reduce the nerve pain a patient has had every day for more than two months. This 4-week study will require patients with neuropathic pain to consume a THC-CBD combination product.

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.

Brian Balin, PhD, 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 was recently published in the journal Cannabis Science and Technology, Vol. 5, No. 9 [June-Wells et al, 2022) (Cannabissciencetech.com).