Zelda Therapeutics (ASX:ZLD) has announced that its phase 1 Opioid Reduction Trial has been formally approved by the St Vincent’s Hospital Ethics and Governance Committees.
The company said the primary end-point is to assess the effectiveness of medicinal cannabis in reducing opioid dependence in patients with chronic non-cancer pain.
The new trial will evaluate the safety and tolerability of whole plant extract following single and repeated doses in nine patients with chronic non-cancer pain on long-term opioid analgesia. Secondary outcomes include pharmacokinetics and the effects on pain, mood, sleep and opioid use over the duration of the trail.
Zelda said the trial will commence immediately with results expected later this year and the outcomes will inform a subsequent larger scale phase 2 study. The phase 2 study will assess the impact of oral whole plant extract on patient ability to tolerate a stepped opioid tapering protocol.
According to Zelda’s managing director, Dr Richard Hopkins, “we’re delighted to have the trial formally underway. To our knowledge, this is the first clinical trial to be designed with a primary end-point assessing the efficacy of a full spectrum plant-derived cannabis formulation containing THC and CBD to reduce opioid dependence in chronic non-cancer patients. If successful, the outcome of these trials will likely have immediate impact in major global markets where opioid overuse and addiction is a major problem.”
The trial will be undertaken jointly with St Vincent’s Hospital in Melbourne.