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      Evaluation of US Food and Drug Administration-recommended abuse-potential questions in chronic pain patients without history of recreational opioid use: results and plan for research

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          Abstract

          Background

          Existing patient-reported outcome (PRO) assessments that measure the human abuse potential for opioid analgesics have been tested exclusively in experienced recreational opioid users, as required by US Food and Drug Administration (FDA) guidance.

          Methods

          The goals of the current studies were to modify items from FDA-recommended abuse potential PRO assessments to specify the analgesic benefits versus the euphoric effects of opioids and to ascertain the clarity, understandability, appropriateness, and validity of the modified questions. This was achieved by conducting cognitive debriefing interviews (CDIs) with patients (≥18 and <65 years) who have chronic pain, were prescribed an opioid daily dose of at least 80 morphine-equivalent milligrams (>30 days to ≤180 days from the date of interview), and did not have a history of recreational opioid use.

          Results

          Participants in study 1 (n=30) and study 2 (n=7) had a better understanding of the items designed to measure the concepts of drug liking and items designed to measure the desire to take a drug again when reasons for liking and desire to take again were included in the item wording (namely, “due to pain relief ” and “excluding pain relief ”). Most participants indicated no interest in taking their medication for reasons other than pain relief.

          Conclusion

          Modification of questions in the PRO assessment improved patient understanding of “drug liking” and “desire to take again.” Patients with chronic pain who were not recreational opioid users understood the difference between the analgesic and euphoric effects of an opioid drug. The modified questions should assist future researchers in providing a more accurate assessment of the abuse potential of an opioid, as required by regulatory agencies.

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          Most cited references 14

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          The drug abuse screening test.

          The Drug Abuse Screening Test (DAST) was designed to provide a brief instrument for clinical screening and treatment evaluation research. The 28 self-report items tap various consequences that are combined in a total DAST score to yield a quantitative index of problems related to drug misuse. Measurement properties of the DAST were evaluated using a clinical sample of 256 drug/alcohol abuse clients. The internal consistency reliability estimate was substantial at .92, and a factor analysis of item intercorrelations suggested an unidimensional scale. With respect to response style biases, the DAST was only moderately correlated with social desirability and denial. Concurrent validity was examined by correlating the DAST with background variables, frequency of drug use during the past 12 months, and indices of psychopathology. Although these findings support the usefulness of the DAST for quantifying the extent of drug involvement within a help-seeking population, further validation work is needed in other populations and settings.
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            The Severity of Dependence Scale (SDS): psychometric properties of the SDS in English and Australian samples of heroin, cocaine and amphetamine users.

            The Severity of Dependence Scale (SDS) was devised to provide a short, easily administered scale which can be used to measure the degree of dependence experienced by users of different types of drugs. The SDS contains five items, all of which are explicitly concerned with psychological components of dependence. These items are specifically concerned with impaired control over drug taking and with preoccupation and anxieties about drug use. The SDS was given to five samples of drug users in London and Sydney. The samples comprised users of heroin and users of cocaine in London, and users of amphetamines and methadone maintenance patients in Sydney. The SDS satisfies a number of criteria which indicate its suitability as a measure of dependence. All SDS items load significantly with a single factor, and the total SDS score was extremely highly correlated with the single factor score. The SDS score is related to behavioural patterns of drug taking that are, in themselves, indicators of dependence, such as dose, frequency of use, duration of use, daily use and degree of contact with other drug users; it also shows criterion validity in that drug users who have sought treatment at specialist and non-specialist agencies for drug problems have higher SDS scores than non-treatment samples. The psychometric properties of the scale were good in all five samples, despite being applied to primary users of different classes of drug, using different recruitment procedures in different cities in different countries.
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              Risk factors for drug dependence among out-patients on opioid therapy in a large US health-care system.

              Our study sought to assess the prevalence of and risk factors for opioid drug dependence among out-patients on long-term opioid therapy in a large health-care system. Using electronic health records, we identified out-patients receiving 4+ physician orders for opioid therapy in the past 12 months for non-cancer pain within a large US health-care system. We completed diagnostic interviews with 705 of these patients to identify opioid use disorders and assess risk factors. Preliminary analyses suggested that current opioid dependence might be as high as 26% [95% confidence interval (CI) = 22.0-29.9] among the patients studied. Logistic regressions indicated that current dependence was associated with variables often in the medical record, including age <65 [odds ratio (OR) = 2.33, P = 0.001], opioid abuse history (OR = 3.81, P < 0.001), high dependence severity (OR = 1.85, P = 0.001), major depression (OR = 1.29, P = 0.022) and psychotropic medication use (OR = 1.73, P = 0.006). Four variables combined (age, depression, psychotropic medications and pain impairment) predicted increased risk for current dependence, compared to those without these factors (OR = 8.01, P < 0.001). Knowing that the patient also had a history of severe dependence and opioid abuse increased this risk substantially (OR = 56.36, P < 0.001). Opioid misuse and dependence among prescription opioid patients in the United States may be higher than expected. A small number of factors, many documented in the medical record, predicted opioid dependence among the out-patients studied. These preliminary findings should be useful in future research efforts. © 2010 The Authors, Addiction © 2010 Society for the Study of Addiction.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2019
                17 December 2018
                : 12
                : 9-15
                Affiliations
                [1 ]Department of Epidemiology and Health Services Research, Geisinger Clinic, Danville, PA 17822, USA, jaboscarino@ 123456geisinger.edu
                [2 ]Medical Affairs, Purdue Pharma, Stamford, CT 06901, USA
                Author notes
                Correspondence: Joseph A Boscarino, Department of Epidemiology and Health Services Research, Geisinger Clinic, 100 North Academy Avenue, MC 44-00, Danville, PA 17822, USA, Tel +1 570 214 9622, Fax +1 570 214 9451, Email jaboscarino@ 123456geisinger.edu
                Article
                jpr-12-009
                10.2147/JPR.S176950
                6301309
                © 2019 Boscarino et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Original Research

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