In the balance: No new diagnosis needed in addition to opioid use disorder to study harms associated with long-term opioid therapy

The inability to reduce or discontinue opioids when benefits do not outweigh harms is concerning and needs to be assessed in patients on long-term opioid therapy for pain (LTOT). Overwhelming evidence finds that increased opioid prescribing fueled by assurances that addiction is rare during LTOT has led to opioid-related harms including falls, overdoses, suicides and opioid use disorder (OUD) [1]. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for OUD better describe opioid-related risks than a new diagnosis exclusively for patients prescribed LTOT.

Decades of research on current and previous DSM criteria support the validity of the OUD diagnosis. Previous editions of the DSM contained two forms of substance use disorders (SUD)—‘substance abuse’ (diagnosed by meeting one of four criteria) and ‘substance dependence’ (diagnosed by meeting three of seven additional criteria including ‘tolerance’ and ‘withdrawal’). The DSM-5 workgroup found no clustering of specific criteria such as ‘loss of control’ with the more severe end of the SUD spectrum [2]. Rather, increasing numbers of criteria met indicated increasing severity of SUD. In DSM-5, an exception was made to exclude ‘tolerance’ and ‘withdrawal’ when diagnosing OUD if opioids are taken ‘under appropriate medical supervision’ [3]. This exclusion was created to avoid an OUD diagnosis in patients prescribed LTOT because these signs are routinely expected. The exclusion was not because these signs did not predict harm or correlate with other OUD criteria.

Both elements of the proposed new LTOT diagnosis are already described by DSM-5 OUD criteria 2 and 9 (see Table 1). ‘Difficulty tapering LTOT’ is indistinguishable from DSM-5 OUD criterion 2 ‘unsuccessful efforts to cut down or control opioid use’. In those with OUD, difficulty cutting down or discontinuing opioid use is driven both by a desire for the positive effects of intoxication and by an imperative to avoid withdrawal and other aversive symptoms such as pain. As tolerance increases, these aversive symptoms are exacerbated during withdrawal. Gradually, avoidance of withdrawal-associated discomfort becomes the major driver for continued substance use [4].

Criterion 9 states that one continues opioid use ‘despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance’; that is, patients continue opioid use although ‘benefits do not outweigh harms’. Clinically, this occurs when patients, after being informed of LTOT harms and risks and evidence of low benefit, nonetheless decline a change in opioid prescribing. If OUD criteria 2 and 9 are present, then a diagnosis of mild OUD is indicated and sufficient for medication treatment (e.g. buprenorphine). The proposal to create a new diagnosis that includes two of the 11 DSM-5 SUD criteria may have unintended consequences including underestimating opioid-related harms, undermining informed consent for pain treatment and further disenfranchising those with illicit OUD.

There is urgent need to help clinicians and patients determine harms and benefits of LTOT for chronic pain. This is best done by following the 2022 Centers for Disease Control and Prevention (CDC) Guidelines for Prescribing Opioids for Pain Recommendation 12 to use DSM-5 OUD criteria [5]. Research determining harms would be enhanced by systematically assessing all 11 DSM-5 SUD criteria in patients receiving LTOT. Assessing all 11 DSM-5 criteria including tolerance and withdrawal would provide insight into additional LTOT-related harms not assessed by the proposed new diagnosis and empirically test whether ‘tolerance’ and ‘withdrawal’ are associated with additional opioid-related harms in this population.

Patients who have difficulty tapering LTOT should receive seamless management by their opioid prescriber. The elimination of the waiver requirement to prescribe buprenorphine for OUD obviates the need for a new diagnosis, as now every United States (US) Drug Enforcement Administration-licensed provider can treat OUD.

It is essential that healthcare providers who prescribe LTOT for chronic pain and patients who receive LTOT understand the continuum between mild, moderate and severe OUD. The problem is not that DSM-5 does not adequately identify LTOT-related harms. Instead, the central problem is that the OUD diagnosis is misunderstood by both clinicians and patients to equate OUD with ‘addiction’—commonly regarded as an epithet rather than a substance-induced chronic illness. The DSM-5 specifically notes that ‘the term “substance use disorder” is used to describe the wide range of the disorder from a mild form to a severe state of chronically relapsing compulsive drug taking.’ By eliminating the potentially stigmatizing and misleading ‘abuse’ and ‘dependence’ nomenclature, DSM-5 already provides a reasonable home for this newly described non-stigmatizing LTOT subcategory within the broad category of OUD.

We assert that CDC recommendation 1 to inform patients of opioid-related risks would be best accomplished by informing patients of all 11 OUD criteria prior to initiating opioids. This would empower patients to make a better-informed choice about the risks of opioid analgesics, to alert their healthcare provider early of emerging signs and symptoms of OUD, and to collaborate to find better safer pain management strategies before they develop OUD. If despite following guidelines for safer opioid prescribing, patients develop an inability to reduce opioid use despite knowledge that opioid-related medical harms outweigh benefits, the discussion about medication treatment for OUD would be less difficult and more collaborative.

We propose that a separate diagnosis may cause public health harm, further stigmatizing people with OUD and widening healthcare disparities among vulnerable populations. If there is a silver lining to the opioid crisis, it is that the nation can no longer ignore OUD and its negative impact on individuals, families and communities, including reductions in life expectancy in the United States [1]. Adding a new diagnosis in an attempt to protect LTOT patients from stigma may have the unintended consequence of leaving those with more severe OUD behind while those with milder disease enjoy preferential access to life-saving medication. This moment in history offers an important opportunity to remove barriers to care for all patients who have opioid-related harms and yet cannot stop their opioid use without medication treatment. Creating a separate diagnosis for those with prescription OUD may undermine this singular benefit and increase disparities in care for those with illicit OUD who are disproportionately persons in minoritized communities.

Karen P Drexler: Conceptualization (equal); project administration (lead); writing—original draft (lead); writing—review and editing (equal). Ellen Lockard Edens: Conceptualization (equal); writing—original draft (supporting); writing—review and editing (equal). Jodie Anne Trafton: Conceptualization (equal); writing—original draft (supporting); writing—review and editing (equal). Wilson Compton: Conceptualization (equal); writing—original draft (supporting); writing—review and editing (equal).

W.M.C. reports long-term holdings in General Electric Company, 3M Companies and Pfizer, Incorporated, unrelated to the present work. E.L.E is a member of the Advisory board of Aspire-365, a substance use disorder treatment company. Other authors report no competing interests.

The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the National Institute on Drug Abuse, the National Institutes of Health, the US Department of Health and Human Services, or the US Department of Veterans Affairs.