07.05.22
Contract research organization Radicle Science, which specializes in large-scale trials on health and wellness products, recently announced the completion of history’s largest human clinical trial studying the effects of cannabinoids on pain management, in partnership with cannabinoids manufacturer Open Book Extracts (OBX). The study, which currently awaits publication, involved six different formulations, each of which contained 40 mg of cannabidiol (CBD) along with one or more other rare cannabinoids such as cannabichromene (CBC) or cannabigerol (CBG).
Over 1,600 participants from across the U.S. with complaints of pain were administered one of the six OBX cannabinoid formulations once daily for a period of four weeks. They reported their pain to the researchers relative to specific benchmarks such as severity, general activity, sleep quality, anxiety symptoms, and overall quality of life.
According to the investigators, each one of the product formulations resulted in statistically significant improvements in pain, anxiety, sleep quality, and overall quality of life domains as reported by the participants.
Across the various product types, 44.8% of participants reported a clinically meaningful improvement in their pain. The various formulations performed roughly the same when it came to reports of pain, anxiety, sleep quality, and quality of life. However, for people with moderate pain, there was evidence that adding 20 mg of CBC to a formulation with 40 mg of CBD could significantly enhance the observed pain-relieving effect, particularly past the two-week threshold.
10% of participants reported side effects throughout the study, however, the researchers characterized all of these side effects as mild.
"We at OBX are fundamentally dedicated to supporting all consumers in their endeavor to feel their best from the inside out through a holistic universe of effective, evidence-based cannabinoid products of the highest quality,” said Dave Neundorfer, OBX chief executive officer. "While existing studies suggest that cannabidiol and rare cannabinoids, including CBG and CBC, have considerable potential to support wellness, there has been a glaring gap in scientifically valid research dedicated to guiding effective product development. That is why we collaborated with the renowned medical experts and data scientists at Radicle Science to better understand the potential of rare cannabinoids as an ingredient and, in particular, their ability to support better quality of life outcomes relating to pain.”
“It is a privilege to make history with OBX,” said Jeff Chen, MD, Radicle Science’s chief executive officer and UCLA Cannabis Research Initiative’s founder and former executive director. “Rare cannabinoids are present in a variety of health and wellness products containing cannabis and hemp, but there has been virtually no clinical data on their effectiveness for any medical condition, including pain. Radicle Science assessed for the first time in history the potential synergistic effects of certain rare cannabinoids on pain and demonstrated that these natural products can make a measurable positive impact.”
The present study is the first clinical trial completed in the Radicle Science and OBX partnership. Similar large-scale, blinded, randomized-controlled trials will be conducted specifically on rare cannabinoids, including THCV, CBN, CBG, and CBC, which OBX will supply. Radicle will study their effects on various health and wellness benefits such as energy, focus, appetite, sleep disturbance, stress, and anxiety across thousands of study participants.
“It was promising to see that the addition of a rare cannabinoid could augment the effects of CBD. We will be further exploring the entourage effect with an upcoming study, Radicle Spectrum, which will be the first head-to-head study comparing full or broad spectrum CBD to isolate and placebo. It is our hope this study will provide data to help the FDA ascertain whether CBD isolate is a drug.”
Over 1,600 participants from across the U.S. with complaints of pain were administered one of the six OBX cannabinoid formulations once daily for a period of four weeks. They reported their pain to the researchers relative to specific benchmarks such as severity, general activity, sleep quality, anxiety symptoms, and overall quality of life.
According to the investigators, each one of the product formulations resulted in statistically significant improvements in pain, anxiety, sleep quality, and overall quality of life domains as reported by the participants.
Across the various product types, 44.8% of participants reported a clinically meaningful improvement in their pain. The various formulations performed roughly the same when it came to reports of pain, anxiety, sleep quality, and quality of life. However, for people with moderate pain, there was evidence that adding 20 mg of CBC to a formulation with 40 mg of CBD could significantly enhance the observed pain-relieving effect, particularly past the two-week threshold.
10% of participants reported side effects throughout the study, however, the researchers characterized all of these side effects as mild.
"We at OBX are fundamentally dedicated to supporting all consumers in their endeavor to feel their best from the inside out through a holistic universe of effective, evidence-based cannabinoid products of the highest quality,” said Dave Neundorfer, OBX chief executive officer. "While existing studies suggest that cannabidiol and rare cannabinoids, including CBG and CBC, have considerable potential to support wellness, there has been a glaring gap in scientifically valid research dedicated to guiding effective product development. That is why we collaborated with the renowned medical experts and data scientists at Radicle Science to better understand the potential of rare cannabinoids as an ingredient and, in particular, their ability to support better quality of life outcomes relating to pain.”
“It is a privilege to make history with OBX,” said Jeff Chen, MD, Radicle Science’s chief executive officer and UCLA Cannabis Research Initiative’s founder and former executive director. “Rare cannabinoids are present in a variety of health and wellness products containing cannabis and hemp, but there has been virtually no clinical data on their effectiveness for any medical condition, including pain. Radicle Science assessed for the first time in history the potential synergistic effects of certain rare cannabinoids on pain and demonstrated that these natural products can make a measurable positive impact.”
The present study is the first clinical trial completed in the Radicle Science and OBX partnership. Similar large-scale, blinded, randomized-controlled trials will be conducted specifically on rare cannabinoids, including THCV, CBN, CBG, and CBC, which OBX will supply. Radicle will study their effects on various health and wellness benefits such as energy, focus, appetite, sleep disturbance, stress, and anxiety across thousands of study participants.
“It was promising to see that the addition of a rare cannabinoid could augment the effects of CBD. We will be further exploring the entourage effect with an upcoming study, Radicle Spectrum, which will be the first head-to-head study comparing full or broad spectrum CBD to isolate and placebo. It is our hope this study will provide data to help the FDA ascertain whether CBD isolate is a drug.”
