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Thursday, December 7, 2023

Cannabis trial finds new high

A new study has found medicinal cannabis can safely provide much-needed physical and mental relief to patients who rely on large doses of drugs, such as morphine, to manage severe pain.

The promising results have emerged from the first stage of a clinical trial that ran in Melbourne and Perth and included a group of chronic non-cancer pain patients who are long-term, high-dose users of opioid-based medications.

The median age of participants in the study was 58.

The trial participants took a daily dose of a cannabinoid medication, in addition to their regular medication, and after a two-week dosing period reported reduced levels of pain, stress, depression and anxiety while experiencing no serious adverse events.

Zelira Therapeutics, a global therapeutic medical cannabis company, ran the study in conjunction with St Vincent’s Hospital in Melbourne and Emerald Clinics in Perth.

Zelira’s Managing Director, Dr Richard Hopkins, said the results exceeded the company’s expectations.

“This is one of the first clinical trials to assess the safety of medicinal cannabis on patients whose pain is so debilitating that they need to take large doses of opioid medications to get through the day,” Dr Hopkins said.

“Not only did we found that our cannabinoid formulation is safe for them to use and did not result in any serious side effects, but we have also seen promising positive effects on their physical and mental wellbeing,” he said.

“We are now well placed to continue our efforts to develop cannabis medicines to help the thousands of Australians who are looking for a safer and better way to manage their chronic pain.”

Key facts and findings from the study were:

  • Seven patients who used at least 60mgs of morphine or equivalent medication daily to treat chronic pain took part in the Phase 1 dose study. The median age of participants was 58 and patients also use a range of medications to treat a number of physical co-morbidities.
  • Patients were given a single dose of Zelira’s cannabis formulation (ZTL-103) containing 5mg of total cannabinoids (2.5mg THC and 2.5mg CBD) on the first day, followed by two daily doses containing 5mg of total cannabinoids per dose for a further 6 days. Patients were gradually escalated to a maximum daily dose of 30 mg of cannabinoids.  Results showed that treatment was safe and all doses were well tolerated by patients. 
  • Pain severity and pain interference were assessed through a patient questionnaire. Patients reported a significant improvement in pain interference scores, which measures how pain impacts a patient’s function and daily life. There was no significant change in pain severity scores.
  • A patient questionnaire was also used to measure anxiety, stress and depression. Scores for each indication fell from severe/moderate to mild/normal during treatment.

Associate Professor Yvonne Bonomo, Principal Investigator for the study, and Director of Department of Addiction Medicine at St Vincent’s Hospital Melbourne said the trial showed that ZTL-103 was safe and well-tolerated in patients diagnosed with chronic pain who were also taking high oMEDD (oral morphine equivalent daily doses).

“This is encouraging given that treatment of chronic pain patients is often complicated by the number of different concurrent medications they can be taking to treat a range of underlying conditions,” said Assoc Prof Bonomo.

“We were also pleased to observe positive efficacy signals for patient-reported pain, stress, anxiety and depression following treatment, which are all measures that impact patient well-being.”

“Prescription opioids for treating chronic pain are linked to serious side effects including physical dependence, which is an acknowledged growing global crisis,” Dr Hopkins said.

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