Ananda Scientific has announced the first patient enrolled in its clinical trial evaluating a cannabidiol-based drug as an adjunctive treatment for Opioid Use Disorder.
The Colorado-headquartered company received approval from the FDA for the trial in January this year. The drug involved is Ananda’s Nantheia ATL5; an investigational drug based using the company’s propriety “Liquid Structure” delivery said to enhance the effectiveness and stability of cannabidiol. An orally administered product, Nantheia ATL5 contains 100mg cannabidiol per softgel capsule.
“The first patient enrolled in this study is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder,” said Dr. Edyth London, one of the Principal Investigators for the trial. “Bridging psychiatry, pharmacology and neuroscience, we are looking to develop evidence-based treatments for addiction.”
The randomized, double-blind, placebo controlled, sequential study involves the use of cannabidiol at dosages of 600/ 1200 mg/day. This will be an adjunctive therapy to buprenorphine and naloxone in opioid use disorder patients.
The primary endpoint of the study is safety and tolerability of CBD in these patients, but there will also be measurements of cue-induced craving, reductions in spontaneous craving, and various other aspects.
“This clinical study is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet need,” said Ananda Scientific CEO Sohail R. Zaidi.
This isn’t the only trial of Nantheia ATL5 Ananda is working on. In May this year, the company announced a collaboration with the University of Nebraska Medical Center (UNMC) to investigate treatment for adults with Post-Traumatic Stress Disorder (PTSD). The phase II double-blind, placebo controlled, randomized clinical study is looking to enroll 240 participants to provide clinical and real-world evaluation of the efficacy and safety of Nantheia ATL5 for PTSD.
A trial of another Ananda formulation – Nantheia A1002N5S – for Opioid Sparing (i.e. use reduction) in the treatment of participants with Radiculopathic Pain Syndromes saw its first patient enrolled in March this year. Like Nantheia ATL5, A1002N5S uses Ananda’s Liquid Structure technology, but only has 50 mg of CBD per soft gel capsule.
The trial involves 40 participants receiving four months of treatment with Nantheia A1002N5S, or placebo, with a follow-up after 2 months.
