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-based company received FDA approval for the trial in January of this year. The drug involved is Ananda’s Nantheia ATL5; an investigational drug based on the company’s “Liquid Structure” delivery that is said to improve the efficacy and stability of cannabidiol. Nantheia ATL5, an orally administered product, contains 100 mg of cannabidiol per gel 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 trial’s principal investigators. “By bringing together psychiatry, pharmacology and neuroscience, we are seeking to develop evidence-based treatments for addiction.”
The sequential, randomized, double-blind, placebo-controlled study involves the use of cannabidiol at doses of 600/1200 mg/day. This will be an adjunctive therapy to buprenorphine and naloxone in patients with opioid use disorders.
The primary focus of the study is the safety and tolerability of CBD in these patients, but there will also be measures of cue-induced craving, reductions in spontaneous craving, and several other aspects.
“This clinical study is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is an important unmet need,” he said. Scientific Ananda CEO Sohail R. Zaidi.
This isn’t the only Nantheia ATL5 test that Ananda is working on. In May of this year, the company announced a collaboration with the University of Nebraska Medical Center (UNMC) to investigate the treatment of adults with post-traumatic stress disorder (PTSD). The phase II randomized, placebo-controlled, double-blind clinical study seeks to enroll 240 participants to provide a real-world clinical evaluation of the efficacy and safety of Nantheia ATL5 for PTSD.
A trial of another Ananda formulation, Nantheia A1002N5S, for opioid sparing (ie, reduced use) in the treatment of participants with radiculopathic pain syndromes saw its first patient registered in March of this year. Like Nantheia ATL5, A1002N5S uses Ananda’s Liquid Structure technology, but only has 50mg of CBD per softgel capsule.
The trial includes 40 participants who receive four months of treatment with Nantheia A1002N5S, or placebo, with a follow-up after 2 months.