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FDA approve trial into CBD capsules as a therapeutic option for opioid addiction

It is hoped the trial will help to reduce the number of opioid deaths in the US

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Opioids: Softgel capsules of CBD in a bottle

The trial is described as a ‘key milestone’ in research examining therapeutic alternatives for opioid use disorder.

It is hoped the study will help to reverse the effects of the ongoing opioid epidemic.

The US-based research-focused biotech company, Ananda Scientific announced its CBD drug will be part of the study taking place at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at the University of California, Los Angeles (UCLA). The drug, Nantheia ATL5 is an oral product that contains 100mg of CBD in a soft gel capsule.

 

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The problem of opioid prescription abuse and addiction in the US is an ongoing problem. The Centres for Disease Control and Prevention (CDC) estimates that 841,000 people have died since 1999 from related drug overdoses. There were 70, 630 drug overdose deaths in the US in 2019 alone.

Sohail R. Zaidi, the chief executive officer of Ananda Scientific said: “This is the fourth IND approval for our investigational drug Nantheia™ product line, and it further re-enforces our vision of developing CBD as a therapeutic for a number of key indications. This clinical study at UCLA is an important component of our clinical development efforts focused on opioid addiction, where a non-addictive therapy is a significant unmet need.”

The trial will be led by Edythe London, Ph.D. professor of Psychiatry and Biobehavioral Sciences, and Richard De La Garza II, Ph.D. professor of Psychiatry and Biobehavioral Sciences at the Jane and Terry Semel Institute at David Geffen School of Medicine UCLA.

Dr London said: “The approval of the IND for this important clinical trial is a key milestone for our ongoing research into therapeutic alternatives for opioid use disorder and reversal of the effects of the opioid epidemic.”

Cannabis and opioid research

Earlier studies have confirmed that cannabis, especially CBD-dominant, strains may be successful when it comes to reducing opioid prescription use in adults.

A study released last year on CBD-dominant cannabis and prescription opioid use involved almost 10,000 patients aged 65 or older. All of the participants held a prescription for medical cannabis from Canadian doctors and their consumption was monitored over a six-year period.

The participants were prescribed either cannabis flower or oil extracts.  The majority chose extracts that had a high percentage of CBD.  They were then given a questionnaire to describe their use, dosage, method of consumption and the efficacy of the medication.

The most common reason that medical cannabis was used was for pain (67.7 per cent) which was more prevalent in women.

Researchers reported that between 20 per cent and one-third of older adults who use CBD-dominant cannabis for medical reasons were able to reduce their use of prescription opioids or benzodiazepines.

Participants reported improvements in pain (72.7 per cent), sleep (64.5 per cent) and mood. Some participants (35.6 per cent) were able to reduce their dose of opioids and 19.9 per cent reduced their dose of benzodiazepines.

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