- Email: [email protected]
Scaling up SBIRT: Statewide implementation in the Oregon health plan
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Abstracts / Drug and Alcohol Dependence 156 (2015) e102–e182
medications or heroin totals nearly 5.2 million, while less than 1.5 million opioid dependent patients are receiving methadone or buprenorphine or naltrexone according to SAMHDA’s National Survey of Substance Abuse Treatment Services (N-SSATS) and IMS Health. Financial support: Funding by the University of Texas at Austin, Center for Social Work Research. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.392 Alternative endpoints based on health outcomes in stimulant users trials Jeanine May 1 , Paul VanVeldhuisen 1 , Colleen Allen 1 , R. Lindblad 1 , L. Hu 1 , Betty Tai 3 , Augustus J. Rush 2 1 The EMMES Corporation, Rockville, MD, United States 2 Duke University, Durham, NC, United States 3 NIDA CCTN, Bethesda, MD, United States
Aims: Identifying patterns of drug use that are consistent with health outcome changes is essential to defining a surrogate measure to evaluate treatment effectiveness and broaden the concept of recovery. The goal is to identify alternative endpoints other than drug use for future trials. Methods: Health outcomes based on the Addiction Severity Index (ASI) and World Health Organization quality of life (WHO-QoL) assessments are explored. ASI composite scores were calculated for seven domains (medical, employment, alcohol use, drug use, legal, family/social, psychiatric) from five randomized controlled trials from the NIDA Clinical Trials Network of stimulant users (N = 1665). Four WHO-QoL domains (physical health, psychological, social relationships, environment) and two questions were assessed in two of the trials (N = 364). Associations between the baseline health outcomes and baseline stimulant use and between the changes in stimulant use and changes in health outcomes were assessed. Results: The drug use ASI composite score is associated with stimulant use. No other associations were found between changes in stimulant use and either ASI-lite composite or the WHO-QoL domain scores. The WHO-QoL question: “How would you rate your quality of life?” showed a potential association with baseline stimulant use. In one study, the average number of baseline stimulant use days for those responding very poor was 12 of the past 30, and for those responding very good, the average was 6 of the past 30. Conclusions: Based on the stimulant user trials evaluated, no measure was identified as related to reduction in drug use outcomes over a short follow-up period. Further investigation of other health outcomes or the development of new metrics related to a meaningful reduction in use is needed. Financial support: NIDA-HHSN271201400028C/N01DA-142237.
In vivo evaluation of novel serotonin 5-HT2C receptor positive allosteric modulator CYD-1-79 Carrie E. McAllister 1 , Rachel M. Hartley 1 , Gongliang Zhang 1 , Robert G. Fox 1 , Noelle C. Anastasio 1,2 , Christopher Wild 1 , Jia Zhou 1,2 , Kathryn A. Cunningham 1,2 1 Center for Addiction Research, University of Texas Medical Branch, Galveston, TX, United States 2 Department of Pharmacology and Toxicology, University of Texas Medical Branch, Galveston, TX, United States
Aims: Minimizing lapses to drug use is an attractive target to improve treatment success in cocaine use disorder. Our recent findings suggest that dampened 5-HT2C R signaling capacity is an important component of vulnerability to relapse. A novel drug design strategy to ameliorate 5-HT2C R hypofunctionality is to develop 5-HT2C R PAMs. Here, we synthesized new chemical entities to develop 5-HT2C R PAMs and evaluated their ability to augment 5-HT2C R signaling in vivo. Methods: Based on the structure of synthetic 5-HT2C R PAM PNU-69176E, we synthesized 35 compounds and evaluated them in a Cai 2+ release assay. We evaluated lead compound CYD-1-79 in rat in vivo DMPK assays and the drug discrimination (DD) assay. Rats were trained to discriminate WAY163909 (0.75 mg/kg, IP) from saline (n = 12). After establishing the WAY163909 dose-response (0.125–1 mg/kg), we assessed CYD-1-79 (0.125–1 mg/kg) in substitution and combination tests. Results: Lead compound CYD-1-79 potentiated 5-HT2C R- and WAY163909-induced Cai 2+ release in stably transfected h5-HT2C RCHO cells (p < 0.05), but alone did not alter Cai 2+ release. After administration of CYD-1-79 (50 mg/kg), 555 ng/g was recovered from rat brains. In the DD assay, 1 mg/kg of CYD-1-79 evoked a partial substitution. A combination of low doses of CYD-179 plus WAY163909 fully substituted for the training dose (90% WAY163909-lever responding). Conclusions: We have synthesized new chemical entities with the profile of 5-HT2C R PAMs; CYD-1-79 crosses the blood-brain barrier and evokes behavioral effects consistent with a 5-HT2C R PAM. Optimization of our newly identified 5-HT2C R PAMs and further evaluation in preclinical models will allow us to develop novel pharmacotherapies for cocaine use disorder. Financial support: MH093844, DA020087, DA033374, DA007287. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.394 Scaling up SBIRT: Statewide implementation in the Oregon health plan Dennis McCarty 1 , Traci R. Rieckmann 1 , Stephanie Renfro 2 , John McConnell 2 1
http://dx.doi.org/10.1016/j.drugalcdep.2015.07.393
Public Health, OHSU, Portland, OR, United States Center for Health Systems Effectiveness, Oregon Health & Science University, Portland, OR, United States 2
Aims: Oregon approved 16 Coordinated Care Organizations (CCOs) to manage and provide primary care and care for mental health and substance use disorders for Medicaid recipients. To monitor quality of care CCOs report on performance measures including the percentage of adults 18 years and older who completed a validated structured screen for alcohol or drug abuse. The analysis examines change in the use of screening and brief
Abstracts / Drug and Alcohol Dependence 156 (2015) e102–e182
intervention and describes the challenges and solutions supporting statewide and regional implementation. Methods: A mixed methods analysis describes Oregon’s statewide implementation of screening and brief intervention. Medicaid utilization data assessed change in the percent of adults screened and variation among CCOs. Procedure codes (i.e., 99408, 99409, 99420 plus V79.1 or V82.9, V79.1, G0442, G0396, or G0397) tracked the number of patients who completed a standardized and validated instrument for assessing at risk alcohol and drug use. Qualitative interviews with CCO leadership and other stakeholders identified implementation challenges and processes. Results: Medicaid utilization data reflected minimal implementation of screening and brief intervention during baseline (2010 and 2011) (1% screen rate) and through the second half of 2012 (2%). Change accelerated in the first half of 2013 (3–4%); CCOs varied between 1% and 8%. Qualitative analysis noted the challenges of training staff, changing workflow in primary care settings, and using the approved procedure codes. Conclusions: Screening for alcohol and drug use disorders may facilitate integration by alerting practitioners to the presence of alcohol and drug use and its contribution to medical problems. Scaling up SBIRT procedures has been a substantial challenge for primary care centers and CCOs. Rates remain low but are increasing. The Oregon Health Authority anticipates that statewide screening will contribute to their efforts to stabilize the costs of care. Financial support: Awards from NIDA (R33 DA035640) and NIMH (R01 MH1000001) supported the investigation. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.395 Opioid prescribing practices of members of the national dental practice based research network Jenna L. McCauley 1 , Valeria V. Gordan 2 , Joseph L. Riley 2 , Roger B. Fillingim 2 , Sonia K. Makhija 3 , Kathleen T. Brady 1 , National Dental PBRN Collaborative Group3 1 Psychiatry, Medical University of South Carolina, Charleston, SC, United States 2 University of Florida, Gainesville, FL, United States 3 University of Alabama at Birmingham, Birmingham, AL, United States
Aims: To examine dental prescribers’ perceptions of prescription opioid misuse among their patients, as well as their familiarity with and use of recommended opioid prescribing risk mitigation strategies. Methods: Participants (n = 537) were recruited between October 15 and November 3, 2014, to participate in a fivequestion ‘Quick Poll’ via an email disseminated to the membership of the National Dental Practice Based Research Network (www. NationalDentalPBRN.org). Questions assessed frequency of: (1) opioid prescribing; (2) concern regarding potential patient misuse of prescribed opioids; (3) patient education; (4) use of their state’s prescription drug monitoring program (PDMP); and (5) interest in continuing education opportunities germane to prescription opioid risk mitigation strategies. Results: The majority of respondents (80%) reported at least monthly opioid prescribing. Among prescribing respondents (n = 429), concerns of patient misuse of opioids were prevalent (75%); however, regular provision of patient education and PDMP use were not common. One-quarter of respondents were not aware of their state’s PDMP program. Interest in continuing education was high (83%).
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Conclusions: Results indicate that although many dentists reported prescribing opioids for pain management, knowledge and implementation of risk mitigation strategies was not common among this group of practitioners. Future research should apply more rigorous methodologies to examine current dental prescribing practices and the relative contribution of dental opioid prescriptions to misuse, abuse, and diversion. Efforts should be made to extend educational opportunities to dentists regarding use of PDMPs, as well as other risk mitigation strategies. Financial support: NIDA K12 DA031794 (KTB); NIDCR U19 DE022516 (GHG). http://dx.doi.org/10.1016/j.drugalcdep.2015.07.396 Remotely monitoring smoking and relapse in adolescents and emerging adults Erin A. McClure 1 , Matthew J. Carpenter 1 , Frank A. Treiber 2 , Kevin M. Gray 1 1
Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charelston, SC, United States 2 College of Nursing, Medical University of South Carolina, Charleston, SC, United States Aims: Adolescent and emerging adult smokers are highly likely to continue smoking into adulthood, resulting almost inevitably in smoking-related illnesses. Understanding the process of relapse to smoking during a quit attempt is critical for the development of highly efficacious treatment interventions, yet very little is known about the natural history of relapse in this group. A comprehensive technology-based monitoring system would allow for the detailed analysis of smoking and relapse and is a highly fruitful avenue to explore. Methods: With this goal in mind, a remote monitoring system to detect smoking was developed that utilizes biochemical verification of smoking through breath carbon monoxide (CO) with ecological momentary assessment (EMA), delivered via a smartphone platform (Android and iOS). The process of developing this application (app) was iterative and decision-making was based on preliminary acceptability ratings from representative participants. Results: The smartphone app consists of several novel features including facial recognition to ensure identity, character recognition of CO values, dynamic programming based on user input, and immediate data transfer to secure servers to monitor and encourage compliance. These features, among others, contribute substantially to reduced burden for research staff and participants. Conclusions: The use of remote monitoring to detect smoking represents a significant step forward in the improvement of treatment strategies to promote cessation. The development of these systems, however, requires iterative steps and sufficient piloting with the target population prior to implementation. Remotely monitoring smoking allows for the fine-grained characterization of behavioral processes, rather than outcomes that may not capture the complex process of relapse. This knowledge can then inform maximally effective, just-in-time interventions delivered at critical moments to promote long-term abstinence. Financial support: NIDA grants K01DA036739, K12DA031794, ACS IRG 97-2919-14. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.397
Abstracts / Drug and Alcohol Dependence 156 (2015) e102–e182
medications or heroin totals nearly 5.2 million, while less than 1.5 million opioid dependent patients are receiving methadone or buprenorphine or naltrexone according to SAMHDA’s National Survey of Substance Abuse Treatment Services (N-SSATS) and IMS Health. Financial support: Funding by the University of Texas at Austin, Center for Social Work Research. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.392 Alternative endpoints based on health outcomes in stimulant users trials Jeanine May 1 , Paul VanVeldhuisen 1 , Colleen Allen 1 , R. Lindblad 1 , L. Hu 1 , Betty Tai 3 , Augustus J. Rush 2 1 The EMMES Corporation, Rockville, MD, United States 2 Duke University, Durham, NC, United States 3 NIDA CCTN, Bethesda, MD, United States
Aims: Identifying patterns of drug use that are consistent with health outcome changes is essential to defining a surrogate measure to evaluate treatment effectiveness and broaden the concept of recovery. The goal is to identify alternative endpoints other than drug use for future trials. Methods: Health outcomes based on the Addiction Severity Index (ASI) and World Health Organization quality of life (WHO-QoL) assessments are explored. ASI composite scores were calculated for seven domains (medical, employment, alcohol use, drug use, legal, family/social, psychiatric) from five randomized controlled trials from the NIDA Clinical Trials Network of stimulant users (N = 1665). Four WHO-QoL domains (physical health, psychological, social relationships, environment) and two questions were assessed in two of the trials (N = 364). Associations between the baseline health outcomes and baseline stimulant use and between the changes in stimulant use and changes in health outcomes were assessed. Results: The drug use ASI composite score is associated with stimulant use. No other associations were found between changes in stimulant use and either ASI-lite composite or the WHO-QoL domain scores. The WHO-QoL question: “How would you rate your quality of life?” showed a potential association with baseline stimulant use. In one study, the average number of baseline stimulant use days for those responding very poor was 12 of the past 30, and for those responding very good, the average was 6 of the past 30. Conclusions: Based on the stimulant user trials evaluated, no measure was identified as related to reduction in drug use outcomes over a short follow-up period. Further investigation of other health outcomes or the development of new metrics related to a meaningful reduction in use is needed. Financial support: NIDA-HHSN271201400028C/N01DA-142237.
In vivo evaluation of novel serotonin 5-HT2C receptor positive allosteric modulator CYD-1-79 Carrie E. McAllister 1 , Rachel M. Hartley 1 , Gongliang Zhang 1 , Robert G. Fox 1 , Noelle C. Anastasio 1,2 , Christopher Wild 1 , Jia Zhou 1,2 , Kathryn A. Cunningham 1,2 1 Center for Addiction Research, University of Texas Medical Branch, Galveston, TX, United States 2 Department of Pharmacology and Toxicology, University of Texas Medical Branch, Galveston, TX, United States
Aims: Minimizing lapses to drug use is an attractive target to improve treatment success in cocaine use disorder. Our recent findings suggest that dampened 5-HT2C R signaling capacity is an important component of vulnerability to relapse. A novel drug design strategy to ameliorate 5-HT2C R hypofunctionality is to develop 5-HT2C R PAMs. Here, we synthesized new chemical entities to develop 5-HT2C R PAMs and evaluated their ability to augment 5-HT2C R signaling in vivo. Methods: Based on the structure of synthetic 5-HT2C R PAM PNU-69176E, we synthesized 35 compounds and evaluated them in a Cai 2+ release assay. We evaluated lead compound CYD-1-79 in rat in vivo DMPK assays and the drug discrimination (DD) assay. Rats were trained to discriminate WAY163909 (0.75 mg/kg, IP) from saline (n = 12). After establishing the WAY163909 dose-response (0.125–1 mg/kg), we assessed CYD-1-79 (0.125–1 mg/kg) in substitution and combination tests. Results: Lead compound CYD-1-79 potentiated 5-HT2C R- and WAY163909-induced Cai 2+ release in stably transfected h5-HT2C RCHO cells (p < 0.05), but alone did not alter Cai 2+ release. After administration of CYD-1-79 (50 mg/kg), 555 ng/g was recovered from rat brains. In the DD assay, 1 mg/kg of CYD-1-79 evoked a partial substitution. A combination of low doses of CYD-179 plus WAY163909 fully substituted for the training dose (90% WAY163909-lever responding). Conclusions: We have synthesized new chemical entities with the profile of 5-HT2C R PAMs; CYD-1-79 crosses the blood-brain barrier and evokes behavioral effects consistent with a 5-HT2C R PAM. Optimization of our newly identified 5-HT2C R PAMs and further evaluation in preclinical models will allow us to develop novel pharmacotherapies for cocaine use disorder. Financial support: MH093844, DA020087, DA033374, DA007287. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.394 Scaling up SBIRT: Statewide implementation in the Oregon health plan Dennis McCarty 1 , Traci R. Rieckmann 1 , Stephanie Renfro 2 , John McConnell 2 1
http://dx.doi.org/10.1016/j.drugalcdep.2015.07.393
Public Health, OHSU, Portland, OR, United States Center for Health Systems Effectiveness, Oregon Health & Science University, Portland, OR, United States 2
Aims: Oregon approved 16 Coordinated Care Organizations (CCOs) to manage and provide primary care and care for mental health and substance use disorders for Medicaid recipients. To monitor quality of care CCOs report on performance measures including the percentage of adults 18 years and older who completed a validated structured screen for alcohol or drug abuse. The analysis examines change in the use of screening and brief
Abstracts / Drug and Alcohol Dependence 156 (2015) e102–e182
intervention and describes the challenges and solutions supporting statewide and regional implementation. Methods: A mixed methods analysis describes Oregon’s statewide implementation of screening and brief intervention. Medicaid utilization data assessed change in the percent of adults screened and variation among CCOs. Procedure codes (i.e., 99408, 99409, 99420 plus V79.1 or V82.9, V79.1, G0442, G0396, or G0397) tracked the number of patients who completed a standardized and validated instrument for assessing at risk alcohol and drug use. Qualitative interviews with CCO leadership and other stakeholders identified implementation challenges and processes. Results: Medicaid utilization data reflected minimal implementation of screening and brief intervention during baseline (2010 and 2011) (1% screen rate) and through the second half of 2012 (2%). Change accelerated in the first half of 2013 (3–4%); CCOs varied between 1% and 8%. Qualitative analysis noted the challenges of training staff, changing workflow in primary care settings, and using the approved procedure codes. Conclusions: Screening for alcohol and drug use disorders may facilitate integration by alerting practitioners to the presence of alcohol and drug use and its contribution to medical problems. Scaling up SBIRT procedures has been a substantial challenge for primary care centers and CCOs. Rates remain low but are increasing. The Oregon Health Authority anticipates that statewide screening will contribute to their efforts to stabilize the costs of care. Financial support: Awards from NIDA (R33 DA035640) and NIMH (R01 MH1000001) supported the investigation. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.395 Opioid prescribing practices of members of the national dental practice based research network Jenna L. McCauley 1 , Valeria V. Gordan 2 , Joseph L. Riley 2 , Roger B. Fillingim 2 , Sonia K. Makhija 3 , Kathleen T. Brady 1 , National Dental PBRN Collaborative Group3 1 Psychiatry, Medical University of South Carolina, Charleston, SC, United States 2 University of Florida, Gainesville, FL, United States 3 University of Alabama at Birmingham, Birmingham, AL, United States
Aims: To examine dental prescribers’ perceptions of prescription opioid misuse among their patients, as well as their familiarity with and use of recommended opioid prescribing risk mitigation strategies. Methods: Participants (n = 537) were recruited between October 15 and November 3, 2014, to participate in a fivequestion ‘Quick Poll’ via an email disseminated to the membership of the National Dental Practice Based Research Network (www. NationalDentalPBRN.org). Questions assessed frequency of: (1) opioid prescribing; (2) concern regarding potential patient misuse of prescribed opioids; (3) patient education; (4) use of their state’s prescription drug monitoring program (PDMP); and (5) interest in continuing education opportunities germane to prescription opioid risk mitigation strategies. Results: The majority of respondents (80%) reported at least monthly opioid prescribing. Among prescribing respondents (n = 429), concerns of patient misuse of opioids were prevalent (75%); however, regular provision of patient education and PDMP use were not common. One-quarter of respondents were not aware of their state’s PDMP program. Interest in continuing education was high (83%).
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Conclusions: Results indicate that although many dentists reported prescribing opioids for pain management, knowledge and implementation of risk mitigation strategies was not common among this group of practitioners. Future research should apply more rigorous methodologies to examine current dental prescribing practices and the relative contribution of dental opioid prescriptions to misuse, abuse, and diversion. Efforts should be made to extend educational opportunities to dentists regarding use of PDMPs, as well as other risk mitigation strategies. Financial support: NIDA K12 DA031794 (KTB); NIDCR U19 DE022516 (GHG). http://dx.doi.org/10.1016/j.drugalcdep.2015.07.396 Remotely monitoring smoking and relapse in adolescents and emerging adults Erin A. McClure 1 , Matthew J. Carpenter 1 , Frank A. Treiber 2 , Kevin M. Gray 1 1
Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charelston, SC, United States 2 College of Nursing, Medical University of South Carolina, Charleston, SC, United States Aims: Adolescent and emerging adult smokers are highly likely to continue smoking into adulthood, resulting almost inevitably in smoking-related illnesses. Understanding the process of relapse to smoking during a quit attempt is critical for the development of highly efficacious treatment interventions, yet very little is known about the natural history of relapse in this group. A comprehensive technology-based monitoring system would allow for the detailed analysis of smoking and relapse and is a highly fruitful avenue to explore. Methods: With this goal in mind, a remote monitoring system to detect smoking was developed that utilizes biochemical verification of smoking through breath carbon monoxide (CO) with ecological momentary assessment (EMA), delivered via a smartphone platform (Android and iOS). The process of developing this application (app) was iterative and decision-making was based on preliminary acceptability ratings from representative participants. Results: The smartphone app consists of several novel features including facial recognition to ensure identity, character recognition of CO values, dynamic programming based on user input, and immediate data transfer to secure servers to monitor and encourage compliance. These features, among others, contribute substantially to reduced burden for research staff and participants. Conclusions: The use of remote monitoring to detect smoking represents a significant step forward in the improvement of treatment strategies to promote cessation. The development of these systems, however, requires iterative steps and sufficient piloting with the target population prior to implementation. Remotely monitoring smoking allows for the fine-grained characterization of behavioral processes, rather than outcomes that may not capture the complex process of relapse. This knowledge can then inform maximally effective, just-in-time interventions delivered at critical moments to promote long-term abstinence. Financial support: NIDA grants K01DA036739, K12DA031794, ACS IRG 97-2919-14. http://dx.doi.org/10.1016/j.drugalcdep.2015.07.397