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Kim, Ji-Hyun (Jane)

University of British Columbia

Frequent withdrawal is experienced by nearly all opioid dependent persons and is a powerful reason for sustained use. Currently, tapering of opioids is the main strategy for withdrawal management, which is associated with significant treatment dropout and patient dissatisfaction. A botanical formulation has been in use in Vietnam to support opiate detoxification under the tradename Heantos-4 (H-4) and licensed in Canada as a natural health product called Traditional Gastrointestinal Remedy (TGIR). TGIR is a non-opioid medication that controls nausea with both analgesic and sedative properties, with the potential to safely manage withdrawal from opioids with little side effects. This multicentre feasibility study and subsequent confirmatory interventional trial aim to evaluate the impact of TGIR on withdrawal management compared to the standard treatment of opioid tapering. In this two-site, open-label, parallel-group randomized controlled trial, 60 opioid-dependent adults seeking opioid withdrawal treatment will be allocated to receive either the experimental intervention of TGIR or as control, standard protocol for opioid tapering. The primary outcome will be feasibility and secondary efficacy outcomes will include retention in withdrawal treatment, dosing, craving, treatment satisfaction, and psychosocial stress. This study will provide evidence for the feasibility of a subsequent confirmatory interventional trial. Should the claims regarding comparable efficacy and safety to opioid tapering hold, TGIR can become an attractive alternative to standard opioid agonist treatments (OAT). TGIR can be used when opioid agonists are not available or preferred as a non-opioid alternative during detoxification, as well as to support patients who undergo withdrawal without professional help. Further, as a non-opioid solution, TGIR has no inherent overdose risk and low toxicity even at the highest effective dose, which enables community-based withdrawal management. This would improve patient-centered management of withdrawal and expand care for those with limited access to conventional treatment. The herbal compound TGIR, developed following the principles of Traditional Chinese Medicine, demonstrated promising retention rates with few side effects in Vietnam, and shows potential to become an effective non-opioid solution also in Europe and North America.

Text

2024-03-15

Attribution-NonCommercial-NoDerivatives 4.0 International

http://hdl.handle.net/2429/87578

Experimental Medicine

University of British Columbia

UBCV

http://creativecommons.org/licenses/by-nc-nd/4.0/