High-dose nabiximols for cannabis use disorder did not cause concerning changes in lab markers | Research

The takeaway

In a clinical trial using higher-than-standard doses of nabiximols to treat cannabis use disorder, biological markers including liver function and metabolic parameters remained largely stable, supporting safety at these doses.

Addiction researchers, clinical pharmacologists, and clinicians exploring pharmacotherapy for cannabis use disorder.

High-dose nabiximols: no clinically significant changes in liver or metabolic markers

What the researchers found

Sub-chronic exposure to nabiximols at doses higher than typically used for MS treatment did not produce clinically significant changes in biological markers. Laboratory values for liver function, metabolic parameters, and other clinical measures remained stable.

Why it matters

Treating cannabis use disorder with nabiximols likely requires higher doses than MS treatment due to tolerance. Demonstrating safety at these elevated doses is essential before larger efficacy trials can proceed.

The numbers in context

Higher-than-standard nabiximols doses used for CUD treatment. Biological markers including liver function tests monitored throughout treatment. No clinically significant changes observed.

How the study worked

Secondary analysis of biological marker data from a clinical trial using nabiximols for cannabis use disorder. Monitored liver function, metabolic markers, and other clinical laboratory values during treatment with higher-than-standard doses.

What this study cannot tell us

Secondary analysis from a trial likely with a small sample. Short treatment duration (sub-chronic). Does not address long-term safety. Biological markers are only one aspect of safety (does not capture subjective side effects or behavioral outcomes). Population with CUD may tolerate cannabinoids differently than MS patients.

How to read the evidence

Secondary analysis from a clinical trial. Appropriate safety monitoring but limited by sample size and treatment duration.

When this study was published

Published 2023.

The bigger picture

Nabiximols (Sativex) is already approved for MS in many countries. Repurposing it for CUD at higher doses requires separate safety validation. This study helps clear that safety hurdle for future efficacy trials.

Questions still open

What is the maximum safe dose of nabiximols for CUD treatment? Would longer treatment durations reveal safety signals not seen in sub-chronic exposure?

Common questions

What is nabiximols?

Nabiximols (brand name Sativex) is a mouth spray containing approximately equal parts THC and CBD derived from cannabis plants. It is approved in many countries for treating MS-related spasticity and is being investigated as a potential treatment for cannabis use disorder.

Why would a cannabis-based medicine treat cannabis addiction?

Similar to how methadone (an opioid) treats opioid addiction, nabiximols could potentially reduce withdrawal symptoms and cravings by providing controlled cannabinoid exposure. The higher doses needed for CUD reflect the tolerance that develops with regular cannabis use.

Read the original research

Effects of sub-chronic nabiximols on biological markers of individuals undergoing a clinical trial for the treatment of cannabis use disorder.

American journal of translational research, 15(8), 5228-5238

View on PubMed ↗

Citation

Wang, Ruoyu; Trigo, Jose M; Le Foll, Bernard. (2023). Effects of sub-chronic nabiximols on biological markers of individuals undergoing a clinical trial for the treatment of cannabis use disorder.. American journal of translational research, 15(8), 5228-5238.