Using a set of 2006 reviews as a starting point, the work group noted weaknesses, highlighted gaps in knowledge, identified data sets to investigate possible solutions, encouraged or conducted analyses to fill knowledge gaps, monitored relevant new publications, and formulated interim recommendations for proposed changes. The work group elicited input on proposed changes through commentary , expert advisers, the DSM-5 web site , and presentations at over 30 professional meetings . This input led to many further analyses and adjustments. The revisions proposed for DSM-5 aimed to overcome the problems identified with DSM-IV, thereby providing an improved approach to substance use disorders. To this end, the largest question was whether to keep abuse and dependence as two separate disorders. This issue, which applies across substances , had the most data available. Other cross-substance issues included the addition or removal of criteria, the diagnostic threshold, severity indicator, course specifiers, substance-induced disorders, and biomarkers. Substance-specific issues included new withdrawal syndromes, the criteria for nicotine disorders, and neurobehavioral disorder associated with prenatal alcohol exposure. Additional topics for consideration involved gambling and other putative non-substance related behavioral addictions. This article presents the evidence that the work group considered on these issues and the resulting recommendations.The DSM-IV criteria for substance abuse and dependence are shown in Figure 1. Dependence was diagnosed when three or more dependence criteria were met. Among those with no dependence diagnosis, abuse was diagnosed when at least one abuse criterion was met. The division into two disorders was guided by the concept that the “dependence syndrome” formed one dimension of substance problems, while social and interpersonal consequences of heavy use formed another . Although the dimensions were assumed to be related , DSM-IV placed dependence above abuse in a hierarchy by stipulating that abuse should not be diagnosed when dependence was present.

The dependence diagnosis represented a strength of the DSM-IV approach to substance use disorders: it was consistently shown to be highly reliable and was validated with antecedent and concurrent indicators such as treatment utilization, impaired functioning, consumption,flood table and comorbidity . However, other aspects of the DSM-IV approach were problematic. Some issues pertained to the abuse diagnosis and others pertained to the DSM-IV-stipulated relationship of abuse to dependence. First, when diagnosed hierarchically according to DSM-IV, the reliability and validity of abuse were much lower than those for dependence . Second, by definition, a syndrome requires more than one symptom, but nearly half of all abuse cases were diagnosed with only one criterion, most often hazardous use . Third, although abuse is often assumed to be milder than dependence, some abuse criteria indicate clinically severe problems . Fourth, common assumptions about the relationship of abuse and dependence were shown to be incorrect in several studies . The problems pertaining to the DSM-IV hierarchy of dependence over abuse also included “diagnostic orphans” , the case of two dependence criteria and no abuse criteria, potentially a more serious condition than abuse but ineligible for a diagnosis. Also, when the abuse criteria were analyzed without regard to dependence, their test-retest reliability improved considerably , suggesting that the hierarchy, not the criteria, led to their poor reliability. Finally, factor analyses of dependence and abuse criteria showed that the criteria formed one factor or two highly correlated factors , suggesting that the criteria should be combined to represent a single disorder. To further investigate the relationship of abuse and dependence criteria, the work group and other researchers used item response theory analysis, which builds on factor analysis, to better understand how items relate to each other. Item response theory models indicate criterion severity and discrimination . The results from these analyses are often presented graphically , where each curve represents a criterion. Curves toward the right indicate criteria of greater severity; steeper slopes indicate better discrimination .Table 2 lists the 39 articles on the item response theory studies that were examined or conducted by the work group, which include over 200,000 study participants. Two main findings arose, with similar results across substances, countries, adults, adolescents, patients and non-patients. First, unidimensionality was found for all DSM-IV criteria for abuse and dependence except legal problems, indicating that dependence and the remaining abuse criteria all indicate the same underlying condition. Second, while severity rankings of criteria varied somewhat across studies, abuse and dependence criteria were always intermixed across the severity spectrum, similar to the curves shown in Figure 2. Collectively, this large body of evidence supported removing the distinction between abuse and dependence.

Substance use prevalence, attitudes, and norms vary across groups, settings, and cultures . Therefore, the work group examined the studies listed in Table 2 in detail for evidence of age, gender, or other cultural bias in the DSM-5 substance use disorder criteria. Such differences are identified in an item response theory framework by testing for differential item functioning . With the exception of legal problems, the criteria did not consistently indicate differential item functioning across studies. Even where differential item functioning was found , no evidence of differential functioning of the total score was found. Thus, consistent gender or cultural bias was not found, although the extent of the changes proposed for DSM-5 criteria for substance use disorders suggested that there would be value in additional research using different analytic strategies to examine whether gender, age, or ethnic bias exists in the criteria.Support for craving as a substance use disorder criterion comes indirectly from behavioral , imaging, pharmacology , and genetics studies . Some believe that craving and its reduction is central to diagnosis and treatment , although not all agree . Craving is included in the dependence criteria in ICD-10, so adding craving to DSM-5 would increase consistency between the nosologies. Item response theory analyses of data from general population and clinical samples in the United States and elsewhere were used to determine the relationship of craving to the other substance use disorder criteria and whether its addition improved the diagnosis. Craving was measured using questions about a strong desire or urge to use the substance, or such a strong desire to use that one couldn’t think of anything else. Across studies, craving fit well with the other criteria and did not perturb their factor loadings, severity, or discrimination. Differential item functioning was generally no more pronounced for craving than for other criteria. In general population samples , craving fell within the midrange of severity . In clinical samples, craving was in the mid-to-lower range of severity, likely because of high prevalence .Using visual inspection to compare item response theory total information curves for the DSM-5 substance use disorder criteria with and without craving produced inconsistent results . Using statistical tests to compare total information curves, the addition of craving to the dependence criteria did not significantly add information . However, when craving and the three abuse criteria were added, total information was increased significantly for nicotine, alcohol, cannabis, and heroin, although not for cocaine use disorders . Clinicians expressed enthusiasm about adding craving at work group presentations and on the DSM-5 web site. In the end, while the psychometric benefit in adding a craving criterion was equivocal, the view that craving may become a biological treatment target prevailed. While awaiting the development of biological craving indicators, clinicians and researchers can assess craving with questions like those used in the item response theory studies .The studies in Table 2 and others demonstrate that the substance use disorders criteria represent a dimensional condition with no natural threshold. However, a binary diagnostic decision is often needed. To avoid a marked perturbation in prevalence without justification, the work group sought a threshold for DSM-5 substance use disorders that would yield the best agreement with the prevalence of DSM-IV substance abuse and dependence disorders combined. To determine this threshold, data from general population and clinical samples were used to compute prevalences and agreement between DSM-5 substance use disorders and DSM-IV dependence or abuse,indoor plant table examining thresholds of two or more to four or more DSM-5 criteria . As shown, prevalence was very similar, and agreement appeared maximized with the threshold of two or more criteria, so it was selected.

Another recent large independently conducted study further supported this threshold . Concerns that the threshold of two or more criteria is too low have been expressed in the professional and lay press , at presentations, and on the DSM-5 web site . These understandable concerns were weighed against the competing need to identify all cases meriting intervention, including milder cases, for example, those presenting in primary care. Table 3 shows that a concern that “millions more” would be diagnosed with the DSM-5 threshold is unfounded if DSM-5 substance use disorder criteria are assessed and decision rules are followed . Additional concerns about the threshold should be addressed by indicators of severity, which clearly indicate that cases vary in severity. An important exception to making a diagnosis of DSM-5 substance use disorder with two criteria pertains to the supervised use of psychoactive substances for medical purposes, including stimulants, cocaine, opioids, nitrous oxide, sedative-hypnotic/anxiolytic drugs, and cannabis in some jurisdictions . These substances can produce tolerance and withdrawal as normal physiological adaptations when used appropriately for supervised medical purposes. With a threshold of two or more criteria, these criteria could lead to invalid substance use disorder diagnoses even with no other criteria met. Under these conditions, tolerance and withdrawal in the absence of other criteria do not indicate substance use disorders and should not be diagnosed as such. DECISION: Set the diagnostic threshold for DSM-5 substance use disorders at two or more criteria.In DSM-IV, six course specifiers for dependence were provided. Four of these pertained to the time frame and completeness of remission, and two pertained to extenuating circumstances. In DSM-IV, the specifiers for time frame and completeness of remission were complex and little used. To simplify, the work group eliminated partial remission and divided the time frame into two categories, early and sustained. Early remission indicates a period $3 months but ,12 months without meeting DSM-5 substance use disorders criteria other than craving. Three months was selected because data indicated better outcomes for those retained in treatment at least this long . Sustained remission indicates a period lasting $12 months without meeting DSM-5 substance use disorders criteria other than craving. Craving is an exception because it can persist long into remission . The work group noted that many clinical studies define remission and relapse in terms of substance use per se, not in terms of DSM criteria. The work group did not do this in order to remain consistent with DSM-IV criteria, and because the criteria focus on substance-related difficulties, not the extent of use, for the reasons discussed in the section on adding criteria. In addition, a lack of consensus on the level of use associated with a good outcome complicates substance use as a course specifier for the disorder. The extenuating circumstance “in a controlled environment” was unchanged from DSM-IV. DSM-IV also included “on agonist therapy” . To update this category, DSM-5 replaced it with “on maintenance therapy” and provided specific examples. DECISION: Define early remission as $3 to ,12 months without meeting substance use disorders criteria and sustained remission as $12 months without meeting substance use disorders criteria . Update the maintenance therapy category with examples of agonists , antagonists , and tobacco cessation medication .Substance use and other mental disorders frequently co-occur, complicating diagnosis because many symptoms are criteria for intoxication, withdrawal syndrome, or other mental disorders. Before DSM-IV, the non-standardized substance-induced mental disorder criteria had poor reliability and validity. DSM-IV improved this via standardized guidelines to differentiate between “primary” and “substance-induced” mental disorders. In DSM-IV, primary mental disorders were diagnosed if they began prior to substance use or if they persisted for more than 4 weeks after cessation of acute withdrawal or severe intoxication. DSM-IV substance induced mental disorders were defined as occurring during periods of substance intoxication or withdrawal or remitting within 4 weeks thereafter. The symptoms listed for both the relevant disorder and for substance intoxication or withdrawal were counted toward the substance-induced mental disorder only if they exceeded the expected severity of intoxication or withdrawal.