Can a DNA Test Predict Opioid Addiction?

Summary: No, there is no test that can predict opioid addiction. However, a new test can assign a score that estimates risk of opioid addiction based on an individual genetic profile.

Key Points:

• The Food and Drug Administration (FDA) approved a test that uses DNA to determine individual risk of developing opioid use disorder (OUD), a.k.a. opioid addiction.
• The test identifies whether an individual has genes that research identifies as associated with opioid addiction.
• The test may be effective in circumstances when opioids may be prescribed for pain to help patients and providers assess the relative risks and benefits of using opioid medication.

An Effective Test, But Experts are Skeptical

The test, called Avert-D, assesses whether an individual has a “specific set of genetic variants” common to people at high risk of OUD. Here’s how the test works, according to SOLVD Health, the company that makes it:

1. Clinicians collect a buccal swab – that’s a cheek swab from inside the mouth – from patients age 18 or older.
2. Lab tests scan for the presence of 15 genetic polymorphisms, i.e. genes, associated with increased OUD risk.
3. Providers use test results to determine whether to prescribe opioid pain relievers to a patient, or consider an alternative option.

The research provided to the FDA by SOLVD includes a clinical trial of over 300 patients who took prescription opioids for a short period of time – between four and thirty days – and were then evaluated for the presence of OUD one year after starting their prescription. The trial showed:

• 8% accuracy in assigning a correct Elevated Genetic Risk Score
• 2% accuracy in assigning a correct Non-Elevated Genetic Risk Score
• Patients with an Elevated Genetic Risk Score were 16 times more likely to develop OUD than patients with a Non-Elevated Genetic Risk Score

The study makes the following points:

• An elevated risk score does not mean a patient will develop OUD.
• A non-elevated score does not mean a patient won’t develop OUD.

Rather, the research, and the company that manufactures the test, indicates the test should be used as “part of a complete clinical evaluation and risk assessment to determine appropriate pain management strategies.”

As we mention above, some scientists and experts on opioids think the FDA shouldn’t have approved the test.

What the FDA Says, What the Critics Say

The FDA approved the test despite the fact that an independent committee of experts voted 11-2 against approval. The agency indicated approval was necessary because the opioid crisis “calls for innovative measures, as reported in this article in The Washington Post.

Critics of the test warn that people who receive a non-elevated risk score might think the dangers of opioids don’t apply to them, take too much medication too often, and develop OUD despite their non-elevated genetic risk score. Critics of the test are also concerned about the following:

• Patients who refuse the test may be considered drug seekers.
• The test results could be a permanent part of patent records, and could be used against them in the future, including in custody disputes or work/employment related scenarios.
• Doctors pressed for time may rely too much on the test results, and not enough on fully understanding the specific factors unique to each individual patient

On the scientific side, another group of researchers developing a broad genetic test for addiction indicates the number of genes – which we call genetic polymorphisms above – assessed in the test should be far higher: hundreds of thousands, as opposed to a handful.

In response, the Director of the FDA Center for Devices and Radiological Health, the branch responsible for approving DNA tests, William Maisel, said in an interview:

“We felt [test results on genetic risk for OUD] was important information that providers and patients should have access to. You could argue that it’s unethical to withhold that type of product and that type of information from people…We recognize the potential shortcomings of the test. But there are also great benefits.”

Unlike an over-the-counter genetic test developed by 23andMe and approved by the FDA to determine risk of Parkinson’s Disease, the OUD test would require a prescription.

The Role of Genetic Testing in Addiction Treatment

In our culture, and in our medical tradition, we have a habit that’s not so great: we look for quick fixes and magic pills. When stories in the media appear about addiction vaccines or other exciting developments, we get excited just like everyone else. But since we work with people with opioid use disorder every day, we know that addiction is a complex phenomenon, and that each individual with OUD has a unique history. A wide variety of factors contribute to the development of the disordered use of substances, including:

• Environmental factors, i.e. the social determinants of health
• Psychological/emotional factors: presence of mental health disorders
• Life events, such as adverse childhood experiences (ACEs)
• Family circumstances, such as a family member with a substance use disorders (SUD)

Genetics also play a role, but genetic risk is only part of the picture.

In an ideal world, addiction experts hope genetic testing will help clinicians determine risk of addiction, predict response to various treatment modalities, and possibly predict risk of overdose and/or relapse. With all of the potential benefits medical science offers, we know that successful recovery is about more than one medication or one test: it’s about a holistic, integrated approach to treatment that includes the entire person and accounts for all the factors in their life.

Recovery from OUD, of course, happens after OUD develops, but the path to OUD is often just as complex as the road to recovery. That’s why – in an ideal world – a genetic test for addiction risk like the one approved by the FDA will be one part of a risk assessment protocol, rather than a sole determinant, and the decision to prescribe or not prescribe opioids to an individual will be the result of a collaborative process including patient and provider, and meet the specific needs of the patient.

An objective test will help, of course, with final decisions made by humans, for humans, because addiction, at its core is a human problem and a human challenge that we’re confident we can meet and overcome.