DENVER – Denver-based Endourage is launching its first clinical trial on human beings to explore potential benefits of hemp-derived, CBD-rich formulations for people seeking to reduce their alcohol consumption.
The primary objective of the study is to determine whether participants who ingest the CBD-rich formulation will consume less alcohol, and if they experience a reduced desire to consume alcohol. A secondary objective is to measure the impact of the formulation on anxiety and depression, which are mental conditions that can be associated with alcohol use.
The 112-day, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an Endourage proprietary hemp-derived CBD-rich formulation. Thirty-two study participants will be enrolled on a self-referral basis. They will be recruited from Recovery Elevator, an organization that offers support, information, and guidance to people seeking to change their relationship with alcohol.
Recovery Elevator’s founder, Paul Churchill, said that if this study reveals that Endourage’s products are effective in helping people reduce their alcohol dependency, it could potentially have a significant impact in the battle to curb alcohol addiction. The National Institute on Alcohol Abuse and Alcoholism reports that approximately 88,000 people die from alcohol-related causes each year.
“Our community is excited to assist Endourage with this pioneering study,” Churchill said. “It shows that the authorities are taking alcohol addiction seriously. People are saying now it’s time to address the world’s most pressing epidemic, which is addiction. We are excited to explore in a more official role how Endourage’s products can help those who struggle with alcohol addiction.”
The study participants will be divided into four groups. Each group will receive a placebo and either CBD isolate with no terpenes or an Endourage product, which is a full-flower CBD-rich hemp extract with a proprietary blend of hemp-derived terpenes.
“It’s fantastic to have a double-blind placebo-controlled trial to provide evidence-based medicine,” said Dr. Michael Steward, Endourage’s Chief Medical Officer. “We will be evaluating the effectiveness of our formulation to attenuate alcohol consumption.”
The clinical trial was approved by Sterling IRB, an independent review board registered with the US Department of Health and Human Services. Sterling’s mandate is to ensure compliance with federal regulations to protect human participants in research studies.