ANANDA Scientific Inc., a research-focused biopharmaceutical company, today announced the commencement of a clinical trial evaluating Nantheia™ ATL5, an investigational drug using cannabidiol (CBD), leveraging ANANDA’s proprietary delivery technology, co-administered with delta-9-tetrahydrocannabinol (THC), for its potential efficacy in treating co-occurring opioid use disorder (OUD) and chronic pain. (Clinical Trials.gov Identifier: NCT06544291)
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The trial will be conducted at the Yale School of Medicine. The study will be led by Principal Investigator Joao P. De Aquino, M.D., Director of the Pain and Addiction Interaction Neurosciences (PAIN) Laboratory, and Assistant Chief of Inpatient Psychiatry at Yale School of Medicine. Funding for this trial is through a grant from the National Institute on Drug Abuse (NIDA).
The primary objective of this trial is to investigate the therapeutic potential of Nantheia™ ATL5, co-administered with THC, in relieving both pain and cue-induced craving in people with OUD and chronic pain. The secondary objective is to determine if adding a THC dose independently alters the effect of Nantheia™ ATL5 (CBD) alone.
This will be a randomized, double blind, placebo controlled, cross over study with participants who are maintained on stable doses of methadone randomly assigned to receive single doses of Nantheia™ ATL5 (CBD 200mg, 400mg or placebo), with THC (5mg, 10mg or placebo).
“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 could lead to significant advancements in treating these debilitating conditions.”
“We are delighted to be working with Dr. De Aquino and Yale School of Medicine on this important trial for our investigational drug Nantheia™ ATL5,” said Sohail R. Zaidi, ANANDA’s Chief Executive Officer. “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.”
ABOUT NANTHEIA™ ATL5
Nantheia™ ATL5 is an investigational drug that combines cannabidiol with ANANDA’s proprietary Liquid Structure™ delivery technology. Pre-clinical and initial clinical studies show that ANANDA’s Liquid Structure™ delivery technology (licensed from Lyotropic Delivery Systems (LDS) Ltd in Jerusalem, Israel) enhances the effectiveness, consistent absorption and stability of cannabidiol. Nantheia™ ATL5 is an oral product with 100 mg of cannabidiol per softgel capsule.
About ANANDA Scientific
ANANDA Scientific is a leading research-focused biopharmaceutical company focused on developing life changing medicines to transform neuropsychiatric health. The company is currently conducting high-caliber clinical studies evaluating therapeutic indications such as PTSD, Pain, Anxiety, Opioid Use Disorder and Smoking Cessation. The company’s patented delivery technology makes cannabinoids and plant-derived compounds highly bioavailable, water-soluble, and shelf-life stable. ANANDA Scientific is dedicated to producing effective, premium pharmaceutical products that enhance patients’ lives.
This press release includes forward-looking statements that involve risks and uncertainties. Such statements are based on current assumptions and expectations, which may change over time.
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