January 8, 2018

The Promise of Personalized Medicine to Predict Opioid Addiction Risk

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Keri J. Donaldson, MD

Prescient Medicine, Hummelstown, Pennsylvania​


The US opioid crisis is devastating our nation; more than 64,000 deaths from drug overdoses occurred in 2016 alone, and many of the rapidly growing number of deaths are opioid-related. Opioid overdose deaths quadrupled from 1999 to 2015, and prescription opioid overdose deaths were most common among individuals aged 25 to 54 years. Additionally, the economic impact of opioid abuse is profound, with US opioid-related hospitalizations costing about $20 billion annually.

Unfortunately, most of the current solutions are reactive, and the epidemic continues to worsen. What if we could better predict an individual’s risk of becoming dependent on opioids before the treatment decision is made?

Genetic testing and personalized medicine can predict development of diseases like cancer and can also assist in therapeutic agent selection. Examples include pembrolizumab, the first cancer treatment to receive FDA approval based on a patient’s genetics, irrespective of tumor type. When a similar rationale is applied in the setting of opioid treatment, the use of genetics may help to determine an individual’s risk of addiction. Associations of heritability (genetics) and addiction were first described in the 1950s, although until recently we didn’t have the technology to accurately describe these relationships.

In a recently published study, my colleagues and I described genetic variations between opioid-addicted and non–opioid-addicted populations, with the goal of developing a predictive algorithm. Sixteen single genetic mutations in the brain-reward pathways that are thought to play a significant role in an individual’s risk for opioid dependency were found to be informative in generating a risk score. We then evaluated whether this score would separate opioid-addicted and non–opioid-addicted populations. We found that we were able to accurately classify the opioid-addicted and non–opioid-addicted patients with a 97% sensitivity and 87% specificity.

A novel and simple genetic test, called LifeKit® Predict, is unlike any other existing tool. It uses 16 genetic markers involved in the brain-reward pathway to help providers better understand individual risk for opioid addiction. Testing is performed using a simple cheek swab and can be quickly analyzed before the prescription is written. By translating genetic information with predictive intelligence, this test can empower physicians and patients when used as part of their ongoing care. Armed with this predictive insight, physicians can opt for alternative non-opioid therapies for individuals with a high risk of opioid dependency, potentially preventing addiction before it starts—and saving lives in the process.

Every day we’re learning more about how our genes may affect our risk for diseases, including addiction, and how we might respond to certain medications. In addition, the opioid crisis has taught us that substance use disorders and addiction are complex diseases in which multiple factors, including genetics, may have a role. As a result, it’s becoming increasingly important that we have clear genetic information obtained via predictive, personalized medicine to help us make informed treatment decisions. Our study findings suggest that there is now a validated tool to help prevent opioid abuse, which has the potential to positively impact the nation’s growing opioid epidemic.

Financial disclosure:Dr Donaldson is the CEO and Medical Director for Prescient Medicine.

Category: Substance Use Disorder
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