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Papers by Stephen Butler
Journal of Pain Research, 2021
The purpose of this study was to evaluate real-world data related to past 30-day nonmedical use (... more The purpose of this study was to evaluate real-world data related to past 30-day nonmedical use (NMU) and routes of administration of Xtampza ® ER and comparator oxycodone medications in the US as captured within the Addiction Severity Index-Multimedia Version ® (ASI-MV ®). Methods: Data were collected from July 2016 through December 2019 from 647 centers located in 44 states using the ASI-MV, a clinical instrument used to evaluate substance use and treatment planning. Demographic characteristics were assessed using Pearson's chisquare test for categorical data and quarterly NMU rates were calculated. Distribution of route of administration was studied using a proportional reporting ratio (PRR) analysis. Results: Of 192,810 assessments, 42,279 (21.9%) indicated past 30-day NMU of at least one prescription opioid, including Xtampza ER (N=73, 0.2%), other oxycodone ER (n=3802, 9.0%) and oxycodone IR (n=14,579, 34.5%). All quarterly Xtampza ER NMU rates per 100 ASI-MV assessments were significantly lower than those for other oxycodone ER and oxycodone IR. Overall, quarterly Xtampza ER NMU drug utilization adjusted rates were significantly lower than quarterly rates observed for other oxycodone ER NMU but not consistently significantly lower than oxycodone IR NMU. Although not all statistically significant, all ratios from the PRR analysis were less than 1.0, indicating that rates of use of any alternate route, any non-oral route, snorting, and injecting were higher for other oxycodone ER and oxycodone IR than for Xtampza ER. Conclusion: Xtampza ER had significantly lower rates of NMU than other oxycodone ER products and oxycodone IR products, as well as significantly lower rates of non-oral NMU than oxycodone IR products, in a population of individuals seeking substance abuse treatment. Understanding risks associated with different opioid medications is important for prescribers as they manage risks of opioid misuse and abuse with effective pain therapy.
The Journal of Pain, 2016
Tapentadol immediate-release (NUCYNTA) was launched in June 2009 with the extended-release produc... more Tapentadol immediate-release (NUCYNTA) was launched in June 2009 with the extended-release product (Nucyntaâ ER) released in August 2011. Tapentadol is a centrally-acting analgesic with mopioid receptor agonistic and norepinephrine reuptake inhibition activities. In an effort to deter abuse, particularly through unintended routes of administration, the extended-release tablets were manufactured using Intacâ technology to be difficult to crush for intranasal abuse and difficult to solubilize for intravenous abuse. Cases classified in the Intentional Exposure category in the Poison Center Program of the Research Abuse, Diversion, and Addition-Related Surveillance (RADARSâ) System were analyzed and used to test whether the proportion of cases reporting use via injection or inhalation is lower for extended-release tapentadol than for immediate release (IR) tapentadol. Between the launch of the extended-release product and June 2015, there were 303 Intentional Exposures involving ER tapentadol and 217 Intentional Exposures involving IR tapentadol. Of the 303 ER tapentadol intentional exposures, 178 (58.8%) were classified as Suspected Suicides and 47 (15.5%) were Intentional Abuse exposures. Of all ER tapentadol exposures, 5 (1.7%) of the 303 exposures reported use via injection or inhalation, all of which were Intentional Abuse exposures. Of the 217 IR tapentadol cases classified as Intentional Exposure, 55.8% were Suspected Suicide exposures and 14.3% were Intentional Abuse exposures. Ten (4.6%) of these exposures reported use via injection or inhalation. Of these, 8 were Intentional Abuse exposures, 1 was Suspected Suicide, and 1 was Intentional Misuse. The proportion of tapentadol ER exposures mentioning injection or inhalation use is significantly lower than the proportion of IR tapentadol exposures (c 2 =3.95, p=0.047). Though intentional exposures still exist, extended-release tapentadol is associated with fewer incidents of injection or inhalation use in cases reported to the RADARS System poison centers.
How did you know you got the right pill? Prescription opioid identification and measurement error... more How did you know you got the right pill? Prescription opioid identification and measurement error in the abuse deterrent formulation era
Drug and alcohol dependence, Jan 21, 2015
This study aimed to: (a) determine the percentage of ED patients receiving prescriptions for opio... more This study aimed to: (a) determine the percentage of ED patients receiving prescriptions for opioid pain medications that meet the criteria for "high-risk for abuse potential" on the Screener and Opioid Assessment for Patients with Pain (SOAPP(®)-R), (b) determine the percentage of patients with high-risk behavior on the state prescription drug monitoring program (PDMP) database, (c) compare the SOAPP-R with data from the PDMP, and (d) determine psychometric properties of SOAPP-R for ED patients METHODS: Convenience sample of ED patients who were being considered for discharge with a prescription for an opioid pain medication. Subjects completed SOAPP-R on an electronic tablet and PDMP data was obtained. Scores on SOAPP-R ≥18 were defined as "at-risk", and PDMP data showing both ≥4 opioid prescriptions and ≥4 providers in 12 months was considered the criterion standard for high-risk behavior. 82 patients (88.2%) provided consent. 32.9% (n=27) were determined to b...
Background: As people live longer with HIV, chronic pain is becoming a critical focal point, and ... more Background: As people live longer with HIV, chronic pain is becoming a critical focal point, and nonmedical prescription opioid use (NMPU) an attendant risk. We explored age-related differences (>50 vs. <50) in prescription opioid use among people being assessed for substance use disorder, comparing across self-reported HIV and other chronic diseases. Methods: Analyses of 53,303 assessments from 550 treatment centers in the Addiction Severity Index Multimedia Version surveillance system from January 1, 2009 to March 30, 2013. Bivariate analyses (Χ2, median tests) compared age and NMPU across diagnoses and, among >50 with HIV/AIDS, cancer, or diabetes (n=5217), explored disparities in prescription opioid use by addiction severity composites, according to diagnosis. Results: Younger age correlated with NMPU for all diagnoses except HIV/AIDS, where NMPU did not differ by age (p=.40). Among 1636 aged >50 with HIV, diabetes or cancer, 31.4% reported recent prescription opioid...
Journal of Technology in Human Services, 2003
... Emil Chiauzzi, PhD, is Director of Multimedia Development at Inflexxion. Jonas I. Bromberg, P... more ... Emil Chiauzzi, PhD, is Director of Multimedia Development at Inflexxion. Jonas I. Bromberg, PsyD, is Research Scientist at Inflexxion. He ... precontemplation. These figures com-pare well with those reported by Samet and O'Connor (1998). ...
Journal of Medical Internet Research, 2014
Background: Reformulating opioid analgesics to deter abuse is one approach toward improving their... more 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
Journal of Addiction Medicine, 2011
The Clinical Journal of Pain, 2009
Objective: To examine the relationship between the self-report of craving prescription medication... more Objective: To examine the relationship between the self-report of craving prescription medication and subsequent opioid misuse among chronic pain patients prescribed opioids for pain. Methods: Six hundred thirteen (613) patients taking opioid medication for chronic noncancer pain were asked how often they have felt a craving for their medication on a scale from 0 = never to 4= very often. All subjects completed a series of baseline questionnaires. After six months the subjects were administered a structured prescription drug use interview (Prescription Drug Use Questionnaire; PDUQ), and submitted a urine sample for toxicology assessment. Their treating physicians also completed a substance misuse behavior checklist (Prescription Opioid Therapy Questionnaire; POTQ). Results: Three hundred thirty-seven subjects (55.0%) reported that they never felt a craving for their medication, while 276 (45.0%) reported some degree of craving their medication (seldom to very often). Those who reported craving their medication were significantly more often male (p<0.01), unmarried (p<0.05), had lower scores on social desirability (p<0.001), and had been prescribed opioids for a longer time (p<0.05) than those who did not report craving medication. At 6-month follow-up, those who reported craving their medication showed higher scores on the PDUQ (p<0.001), had a higher incidence of physician-rated aberrant drug behavior on the POTQ (p<0.05), showed a higher frequency of abnormal urine toxicology screens (p<0.001) and more often had a positive Aberrant Drug Behavior Index (p<0.001). Discussion: These results suggest that self-reported craving is a potential marker for identification of those at risk for opioid medication misuse.
PLoS ONE, 2011
Background: As a population, non-medical prescription opioid users are not well-defined. We aimed... more Background: As a population, non-medical prescription opioid users are not well-defined. We aimed to derive and describe typologies of prescription opioid use and nonmedical use using latent class analysis in an adult population being assessed for substance abuse treatment. Methods: Latent class analysis was applied to data from 26,314 unique respondents, aged 18-70, self-reporting past month use of a prescription opioid out of a total of 138,928 cases (18.9%) collected by the Addiction Severity Index-Multimedia Version (ASI-MVH), a national database for near real-time prescription opioid abuse surveillance. Data were obtained from November 2005 through December 2009. Substance abuse treatment, criminal justice, and public assistance programs in the United States submitted data to the ASI-MV database (n = 538). Six indicators of the latent classes derived from responses to the ASI-MV, a version of the ASI modified to collect prescription opioid abuse and chronic pain experience. The latent class analysis included respondent home ZIP code random effects to account for nesting of respondents within ZIP code. Results: A four-class adjusted latent class model fit best and defined clinically interpretable and relevant subgroups: Use as prescribed, Prescribed misusers, Medically healthy abusers, and Illicit users. Classes varied on key variables, including race/ ethnicity, gender, concurrent substance abuse, duration of prescription opioid abuse, mental health problems, and ASI composite scores. Three of the four classes (81% of respondents) exhibited high potential risk for fatal opioid overdose; 18.4% exhibited risk factors for blood-borne infections. Conclusions: Multiple and distinct profiles of prescription opioid use were detected, suggesting a range of use typologies at differing risk for adverse events. Results may help clinicians and policy makers better focus overdose and blood-borne infection prevention efforts and intervention strategies for prescription opioid abuse reduction.
The Addiction Severity Index (ASI) is a reliable and valid measure of problem severity among addi... more The Addiction Severity Index (ASI) is a reliable and valid measure of problem severity among addicted patients. Concerns have been raised about the reliability of the Interviewer Severity Rating (ISR), a summary score for each of seven domains. As part of an effort to build a computer-administered ASI, regression equations were developed to predict the ISR. Repeated re-sampling of 1124 ASIs conducted by trained interviewers, permitted derivation of stable regression equations predicting the ISR for each ASI domain from patients ’ answers to pre-selected interview items. The resulting seven Predicted Severity Ratings (PSRs) were tested on eight, standardized vignettes, with “gold standard, ” expert-generated ISRs. Reliabilities
Food, Mood, and Attitude (FMA) is a CD-ROM prevention program developed to decrease risk for eati... more Food, Mood, and Attitude (FMA) is a CD-ROM prevention program developed to decrease risk for eating disorders in college women. Female first-year students (N = 240) were randomly assigned to the intervention (FMA) or control group. Equal numbers of students ―at risk ‖ and ―low risk ‖ to develop an eating disorder were assigned to each condition. Participants in the FMA condition improved on all measures relative to controls. Significant 3-way interactions (time x condition x risk status) were found on measures of internalization of sociocultural attitudes about thinness, shape concerns, and weight concerns, indicating that at-risk participants in the intervention group improved to a greater extent than did low-risk participants. At follow-up, significantly fewer women in the FMA group reported overeating and excessive exercise relative to controls.
Current Medical Research and Opinion, 2020
Objectives Content validation is essential in the development of patient-reported instruments to ... more Objectives Content validation is essential in the development of patient-reported instruments to ensure relevancy and understandability. The aim was to evaluate patient understanding of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) using cognitive interviewing among adults with chronic moderate to severe pain. Methods This qualitative study involved a one-time in-clinic visit to conduct one-on-one cognitive interviews among participants with chronic moderate to severe pain from four groups: (1) Known Opioid Abuse; (2) Known Abuse of Other Substances (e.g. alcohol, benzodiazepines); (3) Opioid Non-abuse; and (4) No Chronic Opioid Use. Patients were recruited from 6 US clinical centers. Concept elicitation questions regarding misuse and abuse were asked at interview start; the POMAQ was completed via a web interface followed by a cognitive interview regarding POMAQ items and response options. Results 56 patients were enrolled. Mean age was 48.7 ± 12.3 years; 57% femal...
Stephen F. Butler, Ph.D. Frederick L. Newman, Ph.D. Innovative Training Systems, Inc, Newton, MA ... more Stephen F. Butler, Ph.D. Frederick L. Newman, Ph.D. Innovative Training Systems, Inc, Newton, MA Florida International University John S. Cacciola, Ph.D. Arlene Frank, Ph.D. University of Pennsylvania Brookside Hospital, Nashua, NH Simon H. Budman, Ph.D. A. Thomas McLellan, Ph.D. Innovative Training Systems, Inc., Newton, MA University of Pennsylvania Sabrina Ford, Ph.D. Jack Blaine, MD Swarthmore College National Institute on Drug Abuse David Gastfriend, MD Karla Moras, Ph.D. Massachusetts General Hospital University of Pennsylvania Ihsan M. Salloum, M.D., M.P.H. Western Psychiatric Institute and Clinic
Drug and Alcohol Dependence, 2017
Journal of Anesthesia & Clinical Research, 2012
Drug and Alcohol Dependence, 2014
Aims: Screening, briefmotivational counseling interventionand referral to treatment (SBIRT) has s... more Aims: Screening, briefmotivational counseling interventionand referral to treatment (SBIRT) has shown to be effective in reducing substance use and related harms among adolescents in clinical settings but it had not been adapted for use in schools. This translational research study aimed to (a) develop a proof of concept, (b) test the feasibility of conducting SBIRT in two urban New York schools, and (c) examine the economic sustainability. Methods: With the cooperation of the New York OSAS, licensed “health clinics” were createdwithin these schools, equippedwith a computer screening program and a trained substance abuse counselor. The computer presented a standard substance screening; provided tailored prevention information to the student and provided counselor guidance for an immediate, private Motivational Interviewing counseling session. Results: In Spring 2012, 248 students were randomly approached to participate; 100% accepted the screening; 42% of them (n=105) reported substance use (vs. 28% reported in schoolwide, anonymous survey). Importantly, 99% of positively screened students voluntarily accepted onemotivational counseling session and68% returned for additional counseling sessions. The SBIRTprocedure did not interfere with academic activities. Conclusions: The SBIRT was feasible to implement and attractive to students, teachers and administration. We believe the acceptance and participation was due the use of non-school personnel and the private, professional and confidential procedures employed. The data offer clear indication that further effectiveness testing is warranted and potentially valuable. SBIRT, as implemented, has been approved for Medicaid (and some private insurance) reimbursement without co-payment to the parents or students. Economicmodeling demonstrates the current national SBIRT reimbursement rates to be adequate to broadly implement and sustain school-based SBIRT in most mid to largesized schools. Financial support: Phoenix House and Treatment Research Institute.
Drug and Alcohol Dependence, 2014
Drug and alcohol dependence, Sep 13, 2017
The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item assessme... more The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item assessment designed to assist in the prediction of aberrant drug-related behavior (ADB) among patients with chronic pain. Recent work has created shorter versions of the SOAPP-R, including a static 12-item short form and two computer-based methods (curtailment and stochastic curtailment) that monitor assessments in progress. The purpose of this study was to cross-validate these shorter versions in two new populations. This retrospective study used data from patients recruited from a hospital-based pain center (n=84) and pain patients followed and treated at primary care centers (n=110). Subjects had been administered the SOAPP-R and assessed for ADB. In real-data simulation, the sensitivity, specificity, and area under the curve (AUC) of each form were calculated, as was the mean test length using curtailment and stochastic curtailment. Curtailment reduced the number of items administered by 30%...
Drug and Alcohol Dependence, 2017
Journal of Pain Research, 2021
The purpose of this study was to evaluate real-world data related to past 30-day nonmedical use (... more The purpose of this study was to evaluate real-world data related to past 30-day nonmedical use (NMU) and routes of administration of Xtampza ® ER and comparator oxycodone medications in the US as captured within the Addiction Severity Index-Multimedia Version ® (ASI-MV ®). Methods: Data were collected from July 2016 through December 2019 from 647 centers located in 44 states using the ASI-MV, a clinical instrument used to evaluate substance use and treatment planning. Demographic characteristics were assessed using Pearson's chisquare test for categorical data and quarterly NMU rates were calculated. Distribution of route of administration was studied using a proportional reporting ratio (PRR) analysis. Results: Of 192,810 assessments, 42,279 (21.9%) indicated past 30-day NMU of at least one prescription opioid, including Xtampza ER (N=73, 0.2%), other oxycodone ER (n=3802, 9.0%) and oxycodone IR (n=14,579, 34.5%). All quarterly Xtampza ER NMU rates per 100 ASI-MV assessments were significantly lower than those for other oxycodone ER and oxycodone IR. Overall, quarterly Xtampza ER NMU drug utilization adjusted rates were significantly lower than quarterly rates observed for other oxycodone ER NMU but not consistently significantly lower than oxycodone IR NMU. Although not all statistically significant, all ratios from the PRR analysis were less than 1.0, indicating that rates of use of any alternate route, any non-oral route, snorting, and injecting were higher for other oxycodone ER and oxycodone IR than for Xtampza ER. Conclusion: Xtampza ER had significantly lower rates of NMU than other oxycodone ER products and oxycodone IR products, as well as significantly lower rates of non-oral NMU than oxycodone IR products, in a population of individuals seeking substance abuse treatment. Understanding risks associated with different opioid medications is important for prescribers as they manage risks of opioid misuse and abuse with effective pain therapy.
The Journal of Pain, 2016
Tapentadol immediate-release (NUCYNTA) was launched in June 2009 with the extended-release produc... more Tapentadol immediate-release (NUCYNTA) was launched in June 2009 with the extended-release product (Nucyntaâ ER) released in August 2011. Tapentadol is a centrally-acting analgesic with mopioid receptor agonistic and norepinephrine reuptake inhibition activities. In an effort to deter abuse, particularly through unintended routes of administration, the extended-release tablets were manufactured using Intacâ technology to be difficult to crush for intranasal abuse and difficult to solubilize for intravenous abuse. Cases classified in the Intentional Exposure category in the Poison Center Program of the Research Abuse, Diversion, and Addition-Related Surveillance (RADARSâ) System were analyzed and used to test whether the proportion of cases reporting use via injection or inhalation is lower for extended-release tapentadol than for immediate release (IR) tapentadol. Between the launch of the extended-release product and June 2015, there were 303 Intentional Exposures involving ER tapentadol and 217 Intentional Exposures involving IR tapentadol. Of the 303 ER tapentadol intentional exposures, 178 (58.8%) were classified as Suspected Suicides and 47 (15.5%) were Intentional Abuse exposures. Of all ER tapentadol exposures, 5 (1.7%) of the 303 exposures reported use via injection or inhalation, all of which were Intentional Abuse exposures. Of the 217 IR tapentadol cases classified as Intentional Exposure, 55.8% were Suspected Suicide exposures and 14.3% were Intentional Abuse exposures. Ten (4.6%) of these exposures reported use via injection or inhalation. Of these, 8 were Intentional Abuse exposures, 1 was Suspected Suicide, and 1 was Intentional Misuse. The proportion of tapentadol ER exposures mentioning injection or inhalation use is significantly lower than the proportion of IR tapentadol exposures (c 2 =3.95, p=0.047). Though intentional exposures still exist, extended-release tapentadol is associated with fewer incidents of injection or inhalation use in cases reported to the RADARS System poison centers.
How did you know you got the right pill? Prescription opioid identification and measurement error... more How did you know you got the right pill? Prescription opioid identification and measurement error in the abuse deterrent formulation era
Drug and alcohol dependence, Jan 21, 2015
This study aimed to: (a) determine the percentage of ED patients receiving prescriptions for opio... more This study aimed to: (a) determine the percentage of ED patients receiving prescriptions for opioid pain medications that meet the criteria for "high-risk for abuse potential" on the Screener and Opioid Assessment for Patients with Pain (SOAPP(®)-R), (b) determine the percentage of patients with high-risk behavior on the state prescription drug monitoring program (PDMP) database, (c) compare the SOAPP-R with data from the PDMP, and (d) determine psychometric properties of SOAPP-R for ED patients METHODS: Convenience sample of ED patients who were being considered for discharge with a prescription for an opioid pain medication. Subjects completed SOAPP-R on an electronic tablet and PDMP data was obtained. Scores on SOAPP-R ≥18 were defined as "at-risk", and PDMP data showing both ≥4 opioid prescriptions and ≥4 providers in 12 months was considered the criterion standard for high-risk behavior. 82 patients (88.2%) provided consent. 32.9% (n=27) were determined to b...
Background: As people live longer with HIV, chronic pain is becoming a critical focal point, and ... more Background: As people live longer with HIV, chronic pain is becoming a critical focal point, and nonmedical prescription opioid use (NMPU) an attendant risk. We explored age-related differences (>50 vs. <50) in prescription opioid use among people being assessed for substance use disorder, comparing across self-reported HIV and other chronic diseases. Methods: Analyses of 53,303 assessments from 550 treatment centers in the Addiction Severity Index Multimedia Version surveillance system from January 1, 2009 to March 30, 2013. Bivariate analyses (Χ2, median tests) compared age and NMPU across diagnoses and, among >50 with HIV/AIDS, cancer, or diabetes (n=5217), explored disparities in prescription opioid use by addiction severity composites, according to diagnosis. Results: Younger age correlated with NMPU for all diagnoses except HIV/AIDS, where NMPU did not differ by age (p=.40). Among 1636 aged >50 with HIV, diabetes or cancer, 31.4% reported recent prescription opioid...
Journal of Technology in Human Services, 2003
... Emil Chiauzzi, PhD, is Director of Multimedia Development at Inflexxion. Jonas I. Bromberg, P... more ... Emil Chiauzzi, PhD, is Director of Multimedia Development at Inflexxion. Jonas I. Bromberg, PsyD, is Research Scientist at Inflexxion. He ... precontemplation. These figures com-pare well with those reported by Samet and O'Connor (1998). ...
Journal of Medical Internet Research, 2014
Background: Reformulating opioid analgesics to deter abuse is one approach toward improving their... more 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
Journal of Addiction Medicine, 2011
The Clinical Journal of Pain, 2009
Objective: To examine the relationship between the self-report of craving prescription medication... more Objective: To examine the relationship between the self-report of craving prescription medication and subsequent opioid misuse among chronic pain patients prescribed opioids for pain. Methods: Six hundred thirteen (613) patients taking opioid medication for chronic noncancer pain were asked how often they have felt a craving for their medication on a scale from 0 = never to 4= very often. All subjects completed a series of baseline questionnaires. After six months the subjects were administered a structured prescription drug use interview (Prescription Drug Use Questionnaire; PDUQ), and submitted a urine sample for toxicology assessment. Their treating physicians also completed a substance misuse behavior checklist (Prescription Opioid Therapy Questionnaire; POTQ). Results: Three hundred thirty-seven subjects (55.0%) reported that they never felt a craving for their medication, while 276 (45.0%) reported some degree of craving their medication (seldom to very often). Those who reported craving their medication were significantly more often male (p<0.01), unmarried (p<0.05), had lower scores on social desirability (p<0.001), and had been prescribed opioids for a longer time (p<0.05) than those who did not report craving medication. At 6-month follow-up, those who reported craving their medication showed higher scores on the PDUQ (p<0.001), had a higher incidence of physician-rated aberrant drug behavior on the POTQ (p<0.05), showed a higher frequency of abnormal urine toxicology screens (p<0.001) and more often had a positive Aberrant Drug Behavior Index (p<0.001). Discussion: These results suggest that self-reported craving is a potential marker for identification of those at risk for opioid medication misuse.
PLoS ONE, 2011
Background: As a population, non-medical prescription opioid users are not well-defined. We aimed... more Background: As a population, non-medical prescription opioid users are not well-defined. We aimed to derive and describe typologies of prescription opioid use and nonmedical use using latent class analysis in an adult population being assessed for substance abuse treatment. Methods: Latent class analysis was applied to data from 26,314 unique respondents, aged 18-70, self-reporting past month use of a prescription opioid out of a total of 138,928 cases (18.9%) collected by the Addiction Severity Index-Multimedia Version (ASI-MVH), a national database for near real-time prescription opioid abuse surveillance. Data were obtained from November 2005 through December 2009. Substance abuse treatment, criminal justice, and public assistance programs in the United States submitted data to the ASI-MV database (n = 538). Six indicators of the latent classes derived from responses to the ASI-MV, a version of the ASI modified to collect prescription opioid abuse and chronic pain experience. The latent class analysis included respondent home ZIP code random effects to account for nesting of respondents within ZIP code. Results: A four-class adjusted latent class model fit best and defined clinically interpretable and relevant subgroups: Use as prescribed, Prescribed misusers, Medically healthy abusers, and Illicit users. Classes varied on key variables, including race/ ethnicity, gender, concurrent substance abuse, duration of prescription opioid abuse, mental health problems, and ASI composite scores. Three of the four classes (81% of respondents) exhibited high potential risk for fatal opioid overdose; 18.4% exhibited risk factors for blood-borne infections. Conclusions: Multiple and distinct profiles of prescription opioid use were detected, suggesting a range of use typologies at differing risk for adverse events. Results may help clinicians and policy makers better focus overdose and blood-borne infection prevention efforts and intervention strategies for prescription opioid abuse reduction.
The Addiction Severity Index (ASI) is a reliable and valid measure of problem severity among addi... more The Addiction Severity Index (ASI) is a reliable and valid measure of problem severity among addicted patients. Concerns have been raised about the reliability of the Interviewer Severity Rating (ISR), a summary score for each of seven domains. As part of an effort to build a computer-administered ASI, regression equations were developed to predict the ISR. Repeated re-sampling of 1124 ASIs conducted by trained interviewers, permitted derivation of stable regression equations predicting the ISR for each ASI domain from patients ’ answers to pre-selected interview items. The resulting seven Predicted Severity Ratings (PSRs) were tested on eight, standardized vignettes, with “gold standard, ” expert-generated ISRs. Reliabilities
Food, Mood, and Attitude (FMA) is a CD-ROM prevention program developed to decrease risk for eati... more Food, Mood, and Attitude (FMA) is a CD-ROM prevention program developed to decrease risk for eating disorders in college women. Female first-year students (N = 240) were randomly assigned to the intervention (FMA) or control group. Equal numbers of students ―at risk ‖ and ―low risk ‖ to develop an eating disorder were assigned to each condition. Participants in the FMA condition improved on all measures relative to controls. Significant 3-way interactions (time x condition x risk status) were found on measures of internalization of sociocultural attitudes about thinness, shape concerns, and weight concerns, indicating that at-risk participants in the intervention group improved to a greater extent than did low-risk participants. At follow-up, significantly fewer women in the FMA group reported overeating and excessive exercise relative to controls.
Current Medical Research and Opinion, 2020
Objectives Content validation is essential in the development of patient-reported instruments to ... more Objectives Content validation is essential in the development of patient-reported instruments to ensure relevancy and understandability. The aim was to evaluate patient understanding of the Prescription Opioid Misuse and Abuse Questionnaire (POMAQ) using cognitive interviewing among adults with chronic moderate to severe pain. Methods This qualitative study involved a one-time in-clinic visit to conduct one-on-one cognitive interviews among participants with chronic moderate to severe pain from four groups: (1) Known Opioid Abuse; (2) Known Abuse of Other Substances (e.g. alcohol, benzodiazepines); (3) Opioid Non-abuse; and (4) No Chronic Opioid Use. Patients were recruited from 6 US clinical centers. Concept elicitation questions regarding misuse and abuse were asked at interview start; the POMAQ was completed via a web interface followed by a cognitive interview regarding POMAQ items and response options. Results 56 patients were enrolled. Mean age was 48.7 ± 12.3 years; 57% femal...
Stephen F. Butler, Ph.D. Frederick L. Newman, Ph.D. Innovative Training Systems, Inc, Newton, MA ... more Stephen F. Butler, Ph.D. Frederick L. Newman, Ph.D. Innovative Training Systems, Inc, Newton, MA Florida International University John S. Cacciola, Ph.D. Arlene Frank, Ph.D. University of Pennsylvania Brookside Hospital, Nashua, NH Simon H. Budman, Ph.D. A. Thomas McLellan, Ph.D. Innovative Training Systems, Inc., Newton, MA University of Pennsylvania Sabrina Ford, Ph.D. Jack Blaine, MD Swarthmore College National Institute on Drug Abuse David Gastfriend, MD Karla Moras, Ph.D. Massachusetts General Hospital University of Pennsylvania Ihsan M. Salloum, M.D., M.P.H. Western Psychiatric Institute and Clinic
Drug and Alcohol Dependence, 2017
Journal of Anesthesia & Clinical Research, 2012
Drug and Alcohol Dependence, 2014
Aims: Screening, briefmotivational counseling interventionand referral to treatment (SBIRT) has s... more Aims: Screening, briefmotivational counseling interventionand referral to treatment (SBIRT) has shown to be effective in reducing substance use and related harms among adolescents in clinical settings but it had not been adapted for use in schools. This translational research study aimed to (a) develop a proof of concept, (b) test the feasibility of conducting SBIRT in two urban New York schools, and (c) examine the economic sustainability. Methods: With the cooperation of the New York OSAS, licensed “health clinics” were createdwithin these schools, equippedwith a computer screening program and a trained substance abuse counselor. The computer presented a standard substance screening; provided tailored prevention information to the student and provided counselor guidance for an immediate, private Motivational Interviewing counseling session. Results: In Spring 2012, 248 students were randomly approached to participate; 100% accepted the screening; 42% of them (n=105) reported substance use (vs. 28% reported in schoolwide, anonymous survey). Importantly, 99% of positively screened students voluntarily accepted onemotivational counseling session and68% returned for additional counseling sessions. The SBIRTprocedure did not interfere with academic activities. Conclusions: The SBIRT was feasible to implement and attractive to students, teachers and administration. We believe the acceptance and participation was due the use of non-school personnel and the private, professional and confidential procedures employed. The data offer clear indication that further effectiveness testing is warranted and potentially valuable. SBIRT, as implemented, has been approved for Medicaid (and some private insurance) reimbursement without co-payment to the parents or students. Economicmodeling demonstrates the current national SBIRT reimbursement rates to be adequate to broadly implement and sustain school-based SBIRT in most mid to largesized schools. Financial support: Phoenix House and Treatment Research Institute.
Drug and Alcohol Dependence, 2014
Drug and alcohol dependence, Sep 13, 2017
The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item assessme... more The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item assessment designed to assist in the prediction of aberrant drug-related behavior (ADB) among patients with chronic pain. Recent work has created shorter versions of the SOAPP-R, including a static 12-item short form and two computer-based methods (curtailment and stochastic curtailment) that monitor assessments in progress. The purpose of this study was to cross-validate these shorter versions in two new populations. This retrospective study used data from patients recruited from a hospital-based pain center (n=84) and pain patients followed and treated at primary care centers (n=110). Subjects had been administered the SOAPP-R and assessed for ADB. In real-data simulation, the sensitivity, specificity, and area under the curve (AUC) of each form were calculated, as was the mean test length using curtailment and stochastic curtailment. Curtailment reduced the number of items administered by 30%...
Drug and Alcohol Dependence, 2017