The first patient has been enrolled in a clinical trial investigating whether CBD could be an effective treatment for opioid use disorder.
Pharmaceutical company, Ananda Scientific, has announced that a clinical trial exploring the use of CBD as a treatment for opioid use disorder, is now underway marking a “key milestone” for the company.
The randomised, double-blind, placebo controlled study, which is funded by the National Institute on Drug Abuse (NIDA) in the US, will evaluate the effectiveness of Ananda’s proprietary CBD formula, known as Nantheia™ ATL5.
Participants will be given cannabidiol (CBD) at doses of 600 and 1200 mg/day as an adjunctive therapy to buprenorphine and naloxone, while also receiving residential behavioural therapy, including cognitive behavioural therapy for opioid use disorder.
Opioids are commonly used for the treatment of pain, and include medicines such as morphine, fentanyl and tramadol, but prolonged use, misuse and use without medical supervision can lead to opioid dependence and other health problems.
According to the World Health Organisation half a million deaths worldwide are attributable to drug use, with more than 70 per cent of those related to opioids.
While CBD and medical cannabis are often used as an alternative treatment to opioids for managing conditions such as chronic pain, much less is known about their potential for treating addiction.
The main objective of the trial will be to assess the safety and tolerability of CBD in these patients, with secondary measures including cue-induced craving, reductions in spontaneous craving, opioid withdrawal, negative affective states, and relapse, as well as retention in treatment with buprenorphine and naloxone.
The trial is being led by principal investigators Distinguished Professor Edythe London, PhD and Professor Richard De La Garza II, PhD of Psychiatry and Biobehavioural Sciences at the Semel Institute, Geffen School of Medicine, UCLA.
“The first patient enrolled in this study is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder,” Dr London commented.
“Bridging psychiatry, pharmacology and neuroscience, we are looking to develop evidence-based treatments for addiction.”
Dr De La Garza added: “We are excited to be moving this trial forward after completing all the preparatory work. We hope this clinical trial will answer important questions about the potential of cannabidiol in the treatment of opioid addiction.”
Sohail R Zaidi, Ananda’s Chief Executive Officer (CEO) said: “We are delighted to have the first patient enrolled in this important trial of our investigational drug Nantheia™ ATL5. This clinical study is an important component of our clinical development efforts focused on opioid addiction, where non-addictive therapy is a significant unmet need.
“We are impressed by the clinical competence and operational diligence of the clinical trial team at UCLA which makes them our partner of choice for future trials as we develop the clinical programme.”
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