Evaluation of Abuse and Route of Administration of Extended-Release Tapentadol Among Treatment-Seeking Individuals, as Captured by the Addiction Severity Index-Multimedia Version (ASI-MV).

BACKGROUND: Tapentadol is a molecule incorporating mu opioid receptor agonism and norepinephrine reuptake inhibition to provide analgesia, with the potential for a lower incidence of gastrointestinal side effects than full mu opioid agonists. Postmarketing surveillance of tapentadol as an active pharmaceutical ingredient has consistently revealed low levels of abuse and diversion. OBJECTIVE: The purpose of the present study was to further characterize the abuse liability of tapentadol extended-release (ER) by evaluating the prevalence of past 30-day tapentadol ER abuse and reported routes of administration as compared with ER opioids with Food and Drug Administration (FDA) abuse-deterrent labeling ("ADF opioids") and ER opioids without FDA abuse-deterrent labeling ("non-ADF opioids"). METHODS: Data were collected from January 2014 through December 2017 from 776 centers located in 43 states throughout the United States using the Addiction Severity Index-Multimedia Version (ASI-MV), an instrument that is integral to the National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO, Inflexxion, an IBH Company, Costa Mesa, CA, USA). RESULTS: Tapentadol ER had lower rates of past 30-day abuse than ADF ER and non-ADF ER opioid comparators, both at a population level and when adjusted for drug utilization. Tapentadol ER was primarily abused orally, although it was also abused through alternate routes of administration. Cumulative rates of tapentadol ER abuse by alternative routes of administration were lower than both ADF and non-ADF ER opioid comparators, although large confidence intervals resulting from the small sample size of reported tapentadol ER use limit firm conclusions. CONCLUSIONS: In summary, tapentadol ER was found to have lower rates of both past 30-day abuse and use via alternate routes of administration, specifically snorting and smoking, than ADF and non-ADF ER comparators.

Development of a Brief Version of the Current Opioid Misuse Measure (COMM): The COMM-9.

Objective: The Current Opioid Misuse Measure (COMM) is a commonly used self-report instrument to identify and monitor aberrant opioid-related behavior in chronic pain patients on opioid therapy. However, the length of the COMM may limit its clinical utility. Additionally, this paper-and-pencil screener requires hand scoring, which increases paperwork and staff burden. Therefore, the current study presents development of the "COMM-9," a brief electronically administered form of the COMM. Methods: Patients (N = 517) with chronic noncancer pain on opioid therapy completed the COMM. Patients were classified as either being positive or negative for aberrant drug-related behavior based on self-report data from a structured interview, physician-report data, and urine toxicology screen (the Aberrant Drug Behavior Index [ADBI]). COMM items with the strongest classification accuracy were identified using the LASSO method as the selection criterion in conjunction with the leave-one-out cross-validation method as the stop criterion. A sub-set of patients (n=55) completed a second administration of the COMM one week later to evaluate test-retest reliability. Results: Nine items were identified before the selection criterion stopped, and logistic regression was utilized to predict probabilities of positive ADBI from the 9 COMM items using all data and the cross-validation procedure. Receiver operating characteristic curves revealed high levels of classification accuracy that were essentially equivalent to the full COMM. Cut-points were identified to classify patients as having no/low risk, moderate risk, and high risk for aberrant opioid-related behavior. Test-retest reliability of the COMM-9 was comparable to the full 17-item COMM. Conclusions: This study presents the successful development of a brief electronic screener to identify current aberrant opioid-related behavior in chronic pain patients on long-term opioid therapy.

Psychometric evaluation of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales.

PURPOSE: The PainCAS is a web-based clinical tool for assessing and tracking pain and opioid risk in chronic pain patients. Despite evidence for its utility within the clinical setting, the PainCAS scales have never been subject to psychometric evaluation. The current study is the first to evaluate the psychometric properties of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales. METHODS: Patients (N = 4797) from treatment centers and hospitals in 16 different states completed the PainCAS as part of routine clinical assessment. A subsample (n = 73) from two hospital-based treatment centers also completed comparator measures. Rasch Rating Scale Models were employed to evaluate the Interference with Daily Activities and Psychological/Emotional Distress scales, and empirical evaluation included assessment of dimensionality, discrimination, item fit, reliability, information, and person-to-item targeting. Additionally, convergent and discriminant validity were evaluated through classical test theory approaches. Convergent validity of the Pain scales was evaluated through correlations with corresponding comparator items. RESULTS: One Interference with Daily Activities item was removed due to poor functioning and discrimination. The retained items from the Interference with Daily Activities and Psychological/Emotional Distress scales conformed to unidimensional Rasch measurement models, yielding satisfactory item fit, reliability, precision, and coverage. Further, results provided support for the convergent and discriminant validity of these two scales. Convergent validity between the PainCAS Pain and BPI Pain items was also strong. CONCLUSION: Taken together, results provide strong psychometric support for these PainCAS Pain scales. Strengths and limitations of the current study are discussed.

Relative Abuse of Crush-Resistant Prescription Opioid Tablets via Alternative Oral Modes of Administration.

Objective: Some crush-resistant tablet formulations (CRTs) reduce prescription opioid abuse by nonoral routes of administration (ROAs), especially insufflation and injection, while oral abuse increases. Oral abuse involving product manipulation vs swallowing whole for CRTs and comparators was examined. Methods: Abuse by oral modes of administration (e.g., swallowing whole, chewing, dissolving in the mouth), was examined using the ASI-MV, a computerized, clinical interview for adults in substance abuse treatment from January 2009 to March 2015. CRTs (reformulated oxycodone extended-release [ER], reformulated oxymorphone ER, and tapentadol ER) were compared with non-CRT versions, morphine ER, and oxycodone immediate-release single entity. Analyses employed descriptive statistics and logistic regression. Results: Among 364,329 unique assessments, 18,135 patients reported oral abuse of the CRTs and comparators examined. CRTs had a higher prevalence of oral abuse involving product manipulation than comparators (P < 0.0001) among all abusers of product. Oral abuse involving product manipulation for CRTs was greater among the subset of patients reporting oral abuse and significantly higher than comparators (P < 0.003). CRTs were significantly less likely than comparators to be swallowed whole (P < 0.0001) and significantly more likely to be chewed (P < 0.003). CRTs were more likely to be dissolved in the mouth than most comparators. Conclusions: Results suggest the need for abuse-deterrent formulations designed to reduce abuse by oral administration with product manipulation, such as chewing. Advances in this area may reduce the overall abuse of prescription opioids and interrupt the progression from abuse by swallowing whole to oral administration involving product manipulation and other ROAs.

Development and Validation of an Eight-Item Brief Form of the SOAPP-R (SOAPP-8).

Objective: Although the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) has become a widely used screener for aberrant opioid-related behavior in adults, the length of the instrument may limit its utility. The purpose of the current study was to develop a short form of the SOAPP-R by retaining as few items as possible while maximizing predictive accuracy. Methods: Participants (N = 555), recruited from pain clinics, completed the 24-item SOAPP-R and participated in a five-month follow-up visit to evaluate aberrant drug-related behaviors. Opioid aberrant-related behavior was determined through self-report, physician report, and urine toxicology screen. The optimal subset of SOAPP-R items to predict aberrant opioid-related behavior was identified empirically by employing the LASSO selection method and the leave-one-out cross-validation (LOOCV) method offered in the GLMSELECT procedure in SAS 9.4 in conjunction with content expertise. Results: Eight items were identified before the selection method stopped. The receiver operating characteristic curve generated from the predicted probabilities from the model produced an area under the curve (AUC) value greater than the AUC value produced by the 24-item SOAPP-R total score and yielded a sensitivity of 0.74 and a specificity of 0.66. Conclusions: These results provide strong preliminary support for the SOAPP-8 as a brief screening tool of aberrant opioid-related behavior in chronic pain patients.

Burden of Schizophrenia or Psychosis-Related Symptoms in Adults Undergoing Substance Abuse Evaluation.

This study evaluated the biopsychosocial characteristics of adults undergoing substance abuse evaluation with potential schizophrenia/psychotic disorder, or possible schizophrenia/psychosis-like symptoms, compared with those with no schizophrenia/psychosis-like symptoms. A cross-sectional, observational study examined 170,201 adults, aged 18 to 30, who completed the Addiction Severity Index-Multimedia Version (ASI-MV). Approximately 10% were classified as having possible schizophrenia/psychosis-like symptoms or potential schizophrenia/psychotic disorder. These patients were more likely to exhibit moderate to extreme severity on employment, medical, legal, substance use, social, and psychiatric status than nonsymptomatic patients. The potential schizophrenia or psychotic disorder cohort was also more likely to have ever experienced physical abuse (odds ratio [OR] = 4.30, 95% confidence interval [CI] = 4.12-4.48) and/or sexual abuse (OR = 4.32, 95% CI = 4.15-4.51) versus the no schizophrenia/psychosis-like symptoms cohort. Findings support a recommendation for routine screening for mental health issues, particularly schizophrenia/psychosis-like symptoms, for adults entering substance use disorder treatment settings. This may increase the likelihood of appropriate and earlier intervention.

Development of Short-Form Versions of the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R): A Proof-of-Principle Study.

BACKGROUND: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item questionnaire designed to assess risk of aberrant medication-related behaviors in chronic pain patients. The introduction of short forms of the SOAPP-R may save time and increase utilization by practitioners. OBJECTIVE: To develop and evaluate candidate SOAPP-R short forms. DESIGN: Retrospective study. SETTING: Pain centers. SUBJECTS: Four hundred and twenty-eight patients with chronic noncancer pain. METHODS: Subjects had previously been administered the full-length version of the SOAPP-R and been categorized as positive or negative for aberrant medication-related behaviors via the Aberrant Drug Behavior Index (ADBI). Short forms of the SOAPP-R were developed using lasso logistic regression. Sensitivity, specificity, and area under the curve (AUC) of all forms were calculated with respect to the ADBI using the complete data set, training-test analysis, and 10-fold cross-validation. The coefficient alpha of each form was also calculated. An external set of 12 pain practitioners reviewed the forms for content. RESULTS: In the complete data set analysis, a form of 12 items exhibited sensitivity, specificity, and AUC greater than or equal to those of the full-length SOAPP-R (which were 0.74, 0.67, and 0.76, respectively). The short form had a coefficient alpha of 0.76. In the training-test analysis and 10-fold cross-validation, it exhibited an AUC value within 0.01 of that of the full-length SOAPP-R. The majority of external practitioners reported a preference for this short form. CONCLUSIONS: The 12-item version of the SOAPP-R has potential as a short risk screener and should be tested prospectively.

Impact of an Electronic Pain and Opioid Risk Assessment Program: Are There Improvements in Patient Encounters and Clinic Notes?

OBJECTIVE: A comprehensive electronic self-report assessment, called PainCAS® (Clinical Assessment System), was developed and implemented in three clinics. PainCAS captures demographic information, pain assessment, quality-of-life variables, and contains validated, electronic versions of screeners for risk of aberrant opioid-related behaviors (the SOAPP and COMM). This investigation sought to determine the impact of PainCAS on documentation of pain and opioid risk evaluations. Exploratory hypotheses examined changes in the content of the patient-provider interaction and any impact on outcome. METHODS: In study 1, chart reviews were conducted between pain patients who completed the electronic program (N = 89) and controls who represented standard of care (N = 120). In study 2, two groups of chronic pain patients (treatment-as-usual Control condition = 75, PainCAS Experimental condition = 72) were interviewed after completing their index clinic visit and completed mailed questionnaires 3 months later. RESULTS: Results revealed significantly more key, pain-relevant chart elements documented in charts of patients who completed the PainCAS than those using a traditional paper questionnaire (Study 1; <0.001). In Study 2, the Experimental group reported more discussion about legal issues, substance use history, and medication safety compared with the Control group (p < 0.05). Satisfaction questionnaire responses supported provider and patient perceived benefit from using PainCAS. However, as expected, no differences were found between conditions on outcome measures of pain, mood, and function. CONCLUSIONS: Results indicate that use of the PainCAS electronic pain assessment improves documentation of chart elements in clinic notes and is associated with increased discussion of key, pain-relevant topics during the clinical visit.

Tapentadol abuse potential: a postmarketing evaluation using a sample of individuals evaluated for substance abuse treatment.

OBJECTIVE: Abuse of prescription opioid pain relievers continues to be a serious public health concern. In contrast to opioids such as oxycodone or morphine, tapentadol, a prescription analgesic, has two mechanisms of action: µ-opioid receptor agonism and norepinephrine reuptake inhibition. As a result of differences in its receptor pharmacology, there may be differences in its abuse profile. As an initial step toward testing this hypothesis, we present a postmarketing examination of tapentadol's abuse liability relative to comparators. METHODS: A sentinel sample of 113,914 individuals assessed for substance abuse treatment as part of the NAVIPPRO ASI-MV(®) surveillance system at 624 facilities in 38 states from January 2011 to September 2012 was examined for prevalence and prescription-adjusted prevalence of past 30-day abuse of tapentadol as a compound and its immediate-release (IR) and extended-release (ER) formulations with oxymorphone, hydromorphone, hydrocodone, morphine, fentanyl, oxycodone, tramadol, and buprenorphine as comparators. RESULTS: Tapentadol abuse was reported significantly less often (P < 0.001) than all comparator compounds. Tapentadol IR abuse prevalence was significantly lower than all comparators except fentanyl IR, which had the next lowest unadjusted abuse prevalence. Prevalence of tapentadol ER abuse was lower than comparators except hydromorphone ER. Low prescription-adjusted estimates were observed for tapentadol as a compound as well as its IR and ER formulations, which were among the lowest observed and the lowest of the Schedule II comparators. Prescription-adjusted risk for tapentadol ER was less than comparators except hydromorphone ER (P = 0.06). CONCLUSIONS: Tapentadol abuse was seen infrequently in this study and, on a prescription basis, was less likely to be abused than most of the examined Schedule II analgesics.

Assessing abuse potential of new analgesic medications following market release: an evaluation of Internet discussion of tapentadol abuse.

OBJECTIVE: Research on substance abusers in treatment suggests that tapentadol, a prescription analgesic, may have relatively low abuse potential. Messages posted by recreational drug abusers on online forums were examined for amount of discussion and endorsement for abuse of tapentadol and comparator drugs. METHODS: Internet messages posted between January 1, 2011 and September 30, 2012 on seven drug-abuse web forums were evaluated. Proportions of posts and unique authors discussing tapentadol were compared with eight comparator compounds. Postcontent was coded to compare endorsement for abuse of tapentadol with two comparators, one drug with high desirability for abuse and one with low desirability for abuse. RESULTS: A total of 1,940,121 messages posted during the study period were copied from selected web forums. The proportion of all posts discussing tapentadol (proportion = 0.0003) was significantly lower than any of the comparator compounds (range of odds ratios from 16.6 to 104.3; P < 0.001). The proportion of unique authors was also lower. Posts coded for endorsement (N = 2,117) yielded an endorsement ratio (Ero) of 2.14 for tapentadol, which was significantly lower than the highly desirable for abuse oxymorphone (ERo = 5.08; P = 0.0011) and was as low as tramadol (ERo = 1.66), which has a long-established profile of low abuse and desirability for abuse. CONCLUSIONS: Recreational abusers posting on web forums appear to be less interested in abusing tapentadol when compared with other, selected prescription analgesics based on the amount of discussion (i.e., fewer posts and authors mentioning tapentadol). Endorsement of the product for abuse was also low.

Shortening the Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R): A Proof-of-Principle Study for Customized Computer-Based Testing.

BACKGROUND: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item self-report instrument that was developed to aid providers in predicting aberrant medication-related behaviors among chronic pain patients. Although the SOAPP-R has garnered widespread use, certain patients may be dissuaded from taking it because of its length. Administrative barriers associated with lengthy questionnaires further limit its utility. OBJECTIVE: To investigate the extent to which two techniques for computer-based administration (curtailment and stochastic curtailment) reduce the average test length of the SOAPP-R without unduly affecting sensitivity and specificity. DESIGN: Retrospective study. SETTING: Pain management centers. SUBJECTS: Four hundred and twenty-eight chronic non-cancer pain patients. METHODS: Subjects had taken the full-length SOAPP-R and been classified by the Aberrant Drug Behavior Index (ADBI) as having engaged or not engaged in aberrant medication-related behavior. Curtailment and stochastic curtailment were applied to the data in post-hoc simulation. Sensitivity and specificity with respect to the ADBI, as well as average test length, were computed for the full-length test, curtailment, and stochastic curtailment. RESULTS: The full-length SOAPP-R exhibited a sensitivity of 0.745 and a specificity of 0.671 for predicting the ADBI. Curtailment reduced the average test length by 26% while exhibiting the same sensitivity and specificity as the full-length test. Stochastic curtailment reduced the average test length by as much as 65% while always exhibiting sensitivity and specificity for the ADBI within 0.035 of those of the full-length test. CONCLUSIONS: Curtailment and stochastic curtailment have potential to improve the SOAPP-R's efficiency in computer-based administrations.

Changes in prevalence of prescription opioid abuse after introduction of an abuse-deterrent opioid formulation.

OBJECTIVE: The reformulation of oxycodone hydrochloride controlled-release (CR) tablets in August 2010 created a natural experiment at a national scale, providing an opportunity to evaluate patterns of abuse of prescription opioids and other drugs before and after introduction of this abuse-deterrent formulation (ADF). DESIGN: Observational, cross-sectional study SETTING: Sentinel sample of adults assessed for substance abuse treatment within the NAVIPPRO® surveillance system SUBJECTS: Two hundred thirty-two thousand and eight hundred seventy-four adults at 437 facilities during January 1, 2008 through December 31, 2011. METHODS: Time-series analysis using logistic regression to estimate quarterly prevalence of past 30-day abuse (adjusted for covariates and prescription volume) and changes in abuse pre-and post-ADF introduction. RESULTS: Increases in abuse prevalence occurred for all prescription opioids as a class and for extended-release (ER) opioids. Significantly greater abuse of ER oxymorphone and buprenorphine occurred in the post-ADF period (relative risk [RR] = 2.91, 95% confidence interval [CI] = 2.59-3.27 and RR = 1.85, 95% CI = 1.74-1.96). Increases in abuse for these two compounds were significant among groups who reported abuse via preferential routes of administration (oral only, snorting only, injection only) post-ADF introduction. CONCLUSIONS: Replacement of a widely prescribed opioid formulation known for its abuse potential alone may have had little impact on overall rates of prescription opioids as a class. However, changes in abuse levels of certain opioids coinciding with ADF introduction suggest possible switching of abuse among this study sample to specific long-acting opioid analgesics. Additional follow-up studies will be important to monitor changing abuse patterns and their public health impact as new opioid formulations are developed and introduced to market.

Monitoring of internet forums to evaluate reactions to the introduction of reformulated OxyContin to deter abuse.

BACKGROUND: Reformulating opioid analgesics to deter abuse is one approach toward improving their benefit-risk balance. To assess sentiment and attempts to defeat these products among difficult-to-reach populations of prescription drug abusers, evaluation of posts on Internet forums regarding reformulated products may be useful. A reformulated version of OxyContin (extended-release oxycodone) with physicochemical properties to deter abuse presented an opportunity to evaluate posts about the reformulation in online discussions. OBJECTIVE: The objective of this study was to use messages on Internet forums to evaluate reactions to the introduction of reformulated OxyContin and to identify methods aimed to defeat the abuse-deterrent properties of the product. METHODS: Posts collected from 7 forums between January 1, 2008 and September 30, 2013 were evaluated before and after the introduction of reformulated OxyContin on August 9, 2010. A quantitative evaluation of discussion levels across the study period and a qualitative coding of post content for OxyContin and 2 comparators for the 26 month period before and after OxyContin reformulation were conducted. Product endorsement was estimated for each product before and after reformulation as the ratio of endorsing-to-discouraging posts (ERo). Post-to-preintroduction period changes in ERos (ie, ratio of ERos) for each product were also calculated. Additionally, post content related to recipes for defeating reformulated OxyContin were evaluated from August 9, 2010 through September 2013. RESULTS: Over the study period, 45,936 posts related to OxyContin, 18,685 to Vicodin (hydrocodone), and 23,863 to Dilaudid (hydromorphone) were identified. The proportion of OxyContin-related posts fluctuated between 6.35 and 8.25 posts per 1000 posts before the reformulation, increased to 10.76 in Q3 2010 when reformulated OxyContin was introduced, and decreased from 9.14 in Q4 2010 to 3.46 in Q3 2013 in the period following the reformulation. The sentiment profile for OxyContin changed following reformulation; the post-to-preintroduction change in the ERo indicated reformulated OxyContin was discouraged significantly more than the original formulation (ratio of ERos=0.43, P<.001). A total of 37 recipes for circumventing the abuse-deterrent characteristics of reformulated OxyContin were observed; 32 were deemed feasible (ie, able to abuse). The frequency of posts reporting abuse of reformulated OxyContin via these recipes was low and decreased over time. Among the 5677 posts mentioning reformulated OxyContin, 825 posts discussed recipes and 498 reported abuse of reformulated OxyContin by such recipes (41 reported injecting and 128 reported snorting). CONCLUSIONS: After introduction of physicochemical properties to deter abuse, changes in discussion of OxyContin on forums occurred reflected by a reduction in discussion levels and endorsing content. Despite discussion of recipes, there is a relatively small proportion of reported abuse of reformulated OxyContin via recipes, particularly by injecting or snorting routes. Analysis of Internet discussion is a valuable tool for monitoring the impact of abuse-deterrent formulations.

Electronic opioid risk assessment program for chronic pain patients: barriers and benefits of implementation.

OBJECTIVES: A preliminary electronic pain assessment program known as Pain Assessment Interview Network, Clinical Advisory System (painCAS), was implemented in 2 pain centers over the course of 10 months to understand the tool's impact on opioid risk assessment documentation and clinical workflow. The program contains validated electronic versions of screeners for opioid misuse risk (SOAPP-R and Current Opioid Misuse Measure). METHODS: Charts of patients with an initial and 2 follow-up visits were randomly selected for review of presence of opioid risk assessments before and after implementation of the electronic assessment program. Clinical and administrative staff members were interviewed to gain their perceptions of the impact of the program. RESULTS: Significant increases were observed in the documentation of opioid risk assessments between the baseline patient chart reviews before implementation of the program (n = 66) and the postintervention patient chart reviews after the implementation of the program (n = 39), for both initial and follow-up clinic visits (P < 0.001). Specific benefits of the program identified by 7 clinicians and 8 administrators included ease of use, reduced paperwork, completion of the assessment before the clinic visit, and incorporation of information directly into an electronic medical record (EMR). Perceived barriers to implementation included poor patient compliance, changes in administration workflow, and difficulties associated with patients with no email addresses, and limited computer skills. CONCLUSIONS: Implementation of an opioid risk electronic pain assessment program significantly increased the likelihood that a risk assessment would be included in the medical record, which has implications for improvement of quality of care.

Shortening the Current Opioid Misuse Measure via computer-based testing: a retrospective proof-of-concept study.

BACKGROUND: The Current Opioid Misuse Measure (COMM) is a self-report questionnaire designed to help identify aberrant drug-related behavior in respondents who have been prescribed opioids for chronic pain. The full-length form of the COMM consists of 17 items. Some individuals, especially compromised individuals, may be deterred from taking the full questionnaire due to its length. This study examined the use of curtailment and stochastic curtailment, two computer-based testing approaches that sequentially determine the test length for each individual, to reduce the respondent burden of the COMM without compromising sensitivity and specificity. METHODS: Existing data from n = 415 participants, all of whom had taken the full-length COMM and had been classified via the Aberrant Drug Behavior Index (ADBI), were divided into training (n = 214) and test (n = 201) sets. Post-hoc analysis of the test set was performed to evaluate the screening results and test lengths that would have been obtained, if curtailment or stochastic curtailment had been used. Sensitivity, specificity, and average test length were calculated for each method and compared with the corresponding values of the full-length test. RESULTS: The full-length COMM had a sensitivity of 0.703 and a specificity of 0.701 for predicting the ADBI. Curtailment reduced the average test length by 22% while maintaining the same sensitivity and specificity as the full-length COMM. Stochastic curtailment reduced the average test length by as much as 59% while always obtaining a sensitivity of at least 0.688 and a specificity of at least 0.701 for predicting the ADBI. CONCLUSIONS: Curtailment and stochastic curtailment have the potential to achieve substantial reductions in respondent burden without compromising sensitivity and specificity. The two sequential methods should be considered for future computer-based administrations of the COMM.

Spanish translation and linguistic validation of the screener and opioid assessment for patients with pain-revised (SOAPP-R).

INTRODUCTION: Given the increase in misuse and abuse of prescription opioids, clinicians clearly benefit from a standardized tool to screen patients being considered for chronic opioid therapy. The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a widely used opioid risk assessment tool in clinical practice. As one third of the US population experiences chronic noncancer pain at any given time, and the Hispanic population now accounts for about 16% of the nation's population, the availability of a Spanish-language SOAPP-R fills an important clinical need. OBJECTIVE: To derive a linguistically validated Spanish-language version of the SOAPP®-R. METHOD: Each step of Spanish translation and linguistic validation of the SOAPP-R was based on the US Food and Drug Administration and the International Society for Pharmacoeconomics and Outcomes Research translation process. RESULT: A linguistically validated Spanish-language version of the SOAPP-R. CONCLUSION: The Spanish SOAPP-R may be useful as a risk assessment tool, considered along with other clinical information, by clinicians who prescribe opioid therapy for patients whose preferred language is Spanish.

Identification of prescription opioid misuse and abuse behaviors and risk factors in chronic pain patients using the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ).

OBJECTIVES: To identify patient risk factors associated with prescription opioid misuse and abuse as well as groupings of misuse and abuse behaviors as measured by the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ). METHODS: Adults with chronic pain requiring long-term treatment with opioids completed the POMAQ and other study questionnaires. Latent class analysis (LCA) was used to examine underlying subgroups exhibiting particular risk profiles. Patient demographic and clinical characteristics were examined as covariates and the concordance between the identified latent classes at-risk classifications and the POMAQ clinical scoring algorithm was assessed. RESULTS: Analysis of data from 809 patients revealed four classes: "chronic pain, low risk" (n = 473, low to no prevalence of POMAQ behaviors), "chronic pain, comorbid condition" (n = 152, high prevalence of anti-anxiety, sleeping pill, and antihistamine use), "at risk" (n = 154, taking more opioids than prescribed and drinking alcohol with opioids more frequently than other groups), and "high risk" (n = 30, highest prevalence of each behavior). The "high risk" group was associated with being younger, less educated, and unemployed compared to other groups. When examining the LCA classes by groups defined by the original POMAQ clinical scoring algorithm, the "high risk" class had the highest proportion of participants identified with abuse behaviors (46.7%), compared to just 4.7% in the "chronic pain, low risk" group. CONCLUSIONS: Findings suggest there are four distinct subgroups of patients defined by chronic opioid misuse and abuse behaviors and support the use of the POMAQ to identify risk factors associated with prescription opioid misuse and abuse.

Measuring online endorsement of prescription opioids abuse: an integrative methodology.

PURPOSE: The ability to track prescription opioid abusers' endorsement of compounds may be valuable in forecasting abuser's preferences. We developed a metric, referred to as the Endorsement Ratio (ERo), to explore the feasibility of quantifying the sentiment expressed by opioid abusers who post online about prescription opioid products. METHODS: Internet posts written between April 1, 2010 and March 31, 2011 and related to six prescription opioid compounds (oxycodone ER, hydrocodone, hydromorphone, oxymorphone, morphine ER, and tramadol) were identified and qualitatively coded. A mixed effects multinomial logistic regression was employed to model the probability of observing endorsing, discouraging, mixed, or unclear messages per compound. Endorsement-to-discouragement ratio (ERo) and ratio of endorsement-to-discouragement ratios (RERo) were estimated for each compound. RESULTS: In the study sample of 12 838 Internet posts, a ranking of endorsement could be established, with oxymorphone as most endorsed (ERo = 7.39), followed by hydromorphone (ERo = 5.02), hydrocodone (ERo = 3.53), oxycodone ER (ERo = 3.23), morphine ER (ERo = 2.71), and tramadol (ERo = 1.76). Relative rankings of products required that route of administration be considered. CONCLUSIONS: This study expands existing Internet monitoring approaches by developing a metric to estimate the endorsement of specific prescription opioid compounds as viewed through the lens of Internet communities. Route of administration must be taken into account when examining preferences of drug abusers for various products. This study did not assess whether the novel metric is valid with respect to classification of abuse rates of different drugs. Further studies examining external validation studies are warranted.

Characterizing the Experience of Tapentadol Nonmedical Use: Mixed Methods Study.

BACKGROUND: The prevalence of abuse, diversion, and web-based endorsement of tapentadol (extended-release [ER], immediate-release [IR]) has been characterized as low compared with other prescription opioids. Little is known about individual experience with tapentadol nonmedical use (NMU). OBJECTIVE: This study aims to pilot web-based survey technologies to investigate the motivation for tapentadol NMU, sources of procurement, routes of administration, tampering methods, doses used, and impressions of tapentadol products (Nucynta and Nucynta ER). METHODS: Recruitment flyers and banner advertisements were placed on the Bluelight website [DragonByte Technologies Ltd] with a link to a web-based survey (Qualtrics) designed to query about individuals' lifetime tapentadol NMU. This web-based survey was followed by an interactive web-based chat (Cryptocat) with respondents who were willing to be contacted. Respondents were queried about sources for obtaining tapentadol, motives for use, routes of administration, tampering methods, drugs used in combination, tablet strengths and dosages, and reasons for continued or discontinued use. Desirability and attractiveness for NMU was rated. RESULTS: Web-based recruitment successfully attracted difficult-to-find study participants. A total of 78 participants reported that tapentadol was obtained from friends and family (ER 11/30, 37%; IR 18/67, 27%), the internet (ER 11/30, 37%; IR 12/67, 18%) or participants' own prescriptions from a doctor (ER 9/30, 30%; IR 17/67, 25%). It was used nonmedically for pain relief (ER 18/30, 60%; IR 33/67, 49%) and multiple psychotropic effects, including relaxation (ER 13/30, 43%; IR 29/67, 43%), reduction in depression or anxiety (ER 7/30, 23%; IR 30/67, 45%), or getting high (ER 12/30, 40%; IR 33/67, 49%). Tapentadol was primarily swallowed (ER 22/30, 73%; IR 55/67, 82%), although snorting (ER 2/30, 7%; IR 8/67, 12%) and injection (ER 2/30, 7%; IR 5/67, 8%) were also reported. The preferred dose for NMU was 100 mg (both ER and IR). The participants reported tapentadol use with benzodiazepines (ER 12/21, 57%; IR 28/47, 60%). Most participants had discontinued tapentadol NMU at the time of survey completion (ER 22/30, 73%; IR 55/67, 82%). Reasons for discontinued ER NMU included side effects (10/22, 46%) and lack of effective treatment (10/22, 46%). Reasons for discontinued IR NMU included lack of access (26/55, 47%) and better NMU options (IR 21/55, 38%). Few individuals were willing to divulge identifying information about themselves for the interactive chat (8/78, 10%), demonstrating the strength of anonymous, web-based surveys. Interactive chat supported the survey findings. A subgroup of participants (4/78, 5%) reported hallucinogenic side effects with high doses. CONCLUSIONS: Web-based surveys can successfully recruit individuals who report drug NMU and those who are difficult to find. Tapentadol NMU appears to occur primarily for pain relief and for its psychotropic effects. Although it was liked by some, tapentadol did not receive a robust pattern of endorsement for NMU.

Clinical scoring algorithm for the prescription opioid misuse and abuse questionnaire (POMAQ).

OBJECTIVE: The Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) was developed to identify prescription opioid misuse and abuse among patients with chronic pain. A clinical scoring algorithm was developed and refined to align with the patient experience. METHODS: This study utilized data from the POMAQ validation study (3033-4, NCT02660606) conducted on a sample of patients with chronic pain living in the United States. The study was carried out in two phases. Two purposefully enriched patient samples, one for each phase, were created based on patient responses to select POMAQ items and the availability of urine and hair samples. Two clinical experts (SHS, SFB) reviewed patient data to classify prescription opioid use behavior. Classification differences were adjudicated by a third clinical expert (JTF). Comparisons were made between the final clinical classification determined by the experts and the proposed classification based on the POMAQ algorithm. RESULTS: Sixty patients were included in Phase I (only POMAQ data) and 52 in Phase II (including POMAQ and ancillary sources [e.g. electronic medical records, urine toxicity screen]). Refinements were made to the POMAQ scoring algorithm following discussions with clinical experts to ensure it was clinically relevant. For both phases, classifications were reviewed and discussed to achieve maximal concordance of classifications across experts. The proposed scoring algorithm was then modified to maximize agreement with the expert interpretation of clinically relevant patient experiences. CONCLUSION: The clinical scoring algorithm for the POMAQ was developed and refined to reflect clinically relevant patient behaviors identified by expert review. Future testing is needed to determine the sensitivity and specificity of this measure.