Ananda Scientific Initiates Clinical Trial of Nantheia™ ATL5 for Opioid Use Disorder and Chronic Pain
Key Insights
Ananda Scientific (search) has begun a clinical trial at Yale School of Medicine to assess Nantheia™ ATL5 (search), a CBD-based investigational drug, for treating co-occurring opioid use disorder (search) (OUD) and chronic pain (search).
The randomized, double-blind, placebo-controlled study will evaluate Nantheia™ ATL5 (search), co-administered with THC, to relieve pain and cue-induced craving in OUD patients maintained on methadone.
The trial's primary goal is to determine the therapeutic potential of Nantheia™ ATL5 (search) with THC, while a secondary objective is to assess if THC independently alters the effect of Nantheia™ ATL5 (CBD) alone.
Ananda Scientific (search) has announced the commencement of a clinical trial evaluating Nantheia™ ATL5 (search), an investigational drug combining cannabidiol (CBD) with Ananda’s proprietary delivery technology, co-administered with delta-9-tetrahydrocannabinol (THC), for the treatment of co-occurring opioid use disorder (search) (OUD) and chronic pain (search). The trial is being conducted at Yale School of Medicine, under the direction of Principal Investigator Joao P. De Aquino, M.D., Director of the Pain and Addiction Interaction Neurosciences (PAIN) Laboratory, and Assistant Chief of Inpatient Psychiatry. Funding for the trial is provided by a grant from the National Institute on Drug Abuse (NIDA).
Study Objectives and Design
The primary objective of the trial is to investigate the therapeutic potential of Nantheia™ ATL5 (search), co-administered with THC, in relieving both pain and cue-induced craving in individuals with OUD and chronic pain (search). A secondary objective is to determine whether adding a THC dose independently alters the effect of Nantheia™ ATL5 (CBD) alone.
The study employs a randomized, double-blind, placebo-controlled, crossover design. Participants maintained on stable doses of methadone will be randomly assigned to receive single doses of Nantheia™ ATL5 (search) (CBD 200mg, 400mg, or placebo), with THC (5mg, 10mg, or placebo).
Nantheia™ ATL5 and Liquid Structure™ Technology
Nantheia™ ATL5 (search) is an investigational drug that combines cannabidiol with Ananda’s proprietary Liquid Structure™ delivery technology. Pre-clinical and initial clinical studies suggest that Ananda’s Liquid Structure™ delivery technology enhances the effectiveness, consistent absorption, and stability of cannabidiol. Nantheia™ ATL5 is administered orally, with each softgel capsule containing 100 mg of cannabidiol.
Expert Commentary
"We are excited to collaborate with ANANDA to get this trial underway," said Dr. De Aquino. "Understanding how CBD, co-administered with low doses of THC, may work together to benefit patients with OUD and chronic pain (search) could lead to significant advancements in treating these debilitating conditions."
Sohail R. Zaidi, ANANDA’s Chief Executive Officer, stated, "This clinical trial is a further important step in our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet medical need."