Browsing by Author "Ghitza, Udi E"
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Item Open Access Buprenorphine physician-pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network.(Addiction (Abingdon, England), 2021-01-11) Wu, Li-Tzy; John, William S; Ghitza, Udi E; Wahle, Aimee; Matthews, Abigail G; Lewis, Mitra; Hart, Brett; Hubbard, Zach; Bowlby, Lynn A; Greenblatt, Lawrence H; Mannelli, Paolo; Pharm-OUD-Care Collaborative InvestigatorsBackground and aims
Physician and pharmacist collaboration may help address the shortage of buprenorphine-waivered physicians and improve care for patients with opioid use disorder (OUD). This study investigated the feasibility and acceptability of a new collaborative care model involving buprenorphine-waivered physicians and community pharmacists.Design
Nonrandomized, single-arm, open-label feasibility trial.Setting
Three office-based buprenorphine treatment (OBBT) clinics and three community pharmacies in the United States.Participants
Six physicians, six pharmacists, and 71 patients aged ≥18 years with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) OUD on buprenorphine maintenance.Intervention
After screening, eligible patients' buprenorphine care was transferred from their OBBT physician to a community pharmacist for 6 months.Measurements
Primary outcomes included recruitment, treatment retention and adherence, and opioid use. Secondary outcomes were intervention fidelity, pharmacists' use of prescription drug monitoring program (PDMP), participant safety, and satisfaction with treatment delivery.Findings
A high proportion (93.4%, 71/76) of eligible participants enrolled into the study. There were high rates of treatment retention (88.7%) and adherence (95.3%) at the end of the study. The proportion of opioid-positive urine drug screens (UDSs) among complete cases (i.e. those with all six UDSs collected during 6 months) at month 6 was (4.9%, 3/61). Intervention fidelity was excellent. Pharmacists used PDMP at 96.8% of visits. There were no opioid-related safety events. Over 90% of patients endorsed that they were "very satisfied with their experience and the quality of treatment offered," that "treatment transfer from physician's office to the pharmacy was not difficult at all," and that "holding buprenorphine visits at the same place the medication is dispensed was very or extremely useful/convenient." Similarly, positive ratings of satisfaction were found among physicians/pharmacists.Conclusions
A collaborative care model for people with opioid use disorder that involves buprenorphine-waivered physicians and community pharmacists appears to be feasible to operate in the United States and have high acceptability to patients.Item Open Access Bupropion and Naltrexone in Methamphetamine Use Disorder.(The New England journal of medicine, 2021-01) Trivedi, Madhukar H; Walker, Robrina; Ling, Walter; Dela Cruz, Adriane; Sharma, Gaurav; Carmody, Thomas; Ghitza, Udi E; Wahle, Aimee; Kim, Mora; Shores-Wilson, Kathy; Sparenborg, Steven; Coffin, Phillip; Schmitz, Joy; Wiest, Katharina; Bart, Gavin; Sonne, Susan C; Wakhlu, Sidarth; Rush, A John; Nunes, Edward V; Shoptaw, StevenBackground
The use of naltrexone plus bupropion to treat methamphetamine use disorder has not been well studied.Methods
We conducted this multisite, double-blind, two-stage, placebo-controlled trial with the use of a sequential parallel comparison design to evaluate the efficacy and safety of extended-release injectable naltrexone (380 mg every 3 weeks) plus oral extended-release bupropion (450 mg per day) in adults with moderate or severe methamphetamine use disorder. In the first stage of the trial, participants were randomly assigned in a 0.26:0.74 ratio to receive naltrexone-bupropion or matching injectable and oral placebo for 6 weeks. Those in the placebo group who did not have a response in stage 1 underwent rerandomization in stage 2 and were assigned in a 1:1 ratio to receive naltrexone-bupropion or placebo for an additional 6 weeks. Urine samples were obtained from participants twice weekly. The primary outcome was a response, defined as at least three methamphetamine-negative urine samples out of four samples obtained at the end of stage 1 or stage 2, and the weighted average of the responses in the two stages is reported. The treatment effect was defined as the between-group difference in the overall weighted responses.Results
A total of 403 participants were enrolled in stage 1, and 225 in stage 2. In the first stage, 18 of 109 participants (16.5%) in the naltrexone-bupropion group and 10 of 294 (3.4%) in the placebo group had a response. In the second stage, 13 of 114 (11.4%) in the naltrexone-bupropion group and 2 of 111 (1.8%) in the placebo group had a response. The weighted average response across the two stages was 13.6% with naltrexone-bupropion and 2.5% with placebo, for an overall treatment effect of 11.1 percentage points (Wald z-test statistic, 4.53; P<0.001). Adverse events with naltrexone-bupropion included gastrointestinal disorders, tremor, malaise, hyperhidrosis, and anorexia. Serious adverse events occurred in 8 of 223 participants (3.6%) who received naltrexone-bupropion during the trial.Conclusions
Among adults with methamphetamine use disorder, the response over a period of 12 weeks among participants who received extended-release injectable naltrexone plus oral extended-release bupropion was low but was higher than that among participants who received placebo. (Funded by the National Institute on Drug Abuse and others; ADAPT-2 ClinicalTrials.gov number, NCT03078075.).Item Open Access Integrating substance abuse care with community diabetes care: implications for research and clinical practice(Substance Abuse and Rehabilitation) Ghitza, Udi E; Wu, Li-Tzy; Tai, BettyItem Open Access Multicomorbidity of chronic diseases and substance use disorders and their association with hospitalization: Results from electronic health records data.(Drug and alcohol dependence, 2018-11) Wu, Li-Tzy; Zhu, He; Ghitza, Udi EBACKGROUND:Chronic diseases are prevalent and the leading causes of mortality. Comorbidity of substance use disorders (SUDs) and chronic diseases is understudied to inform behavioral healthcare integration. OBJECTIVES:This study leveraged electronic health record (EHR) data of 211,880 adults from a large health system to examine prevalence and correlates of comorbidity of SUDs and nine chronic disease groups and to determine their association with hospitalization. METHODS:Logistic regression analyses were conducted to estimate associations between chronic diseases and SUDs. To control for severity of diagnosis, analyses of associations between SUD and hospitalization were stratified by the number of chronic conditions. RESULTS:In the sample, 48.3% had ≥1 chronic condition (hypertension 33.7%, arthritis 16.2%, diabetes 13.7%, chronic kidney disease 9.9%, asthma 9.1%, chronic obstructive pulmonary disease 8.9%, ischemic heart disease 8.3%, cancer 4.6%, and hepatitis 1.3%). Prevalence of SUD (overall 13.3%) among patients increased with multiple chronic conditions (14.3% having SUD among patients with one condition; 21.2% having SUD among patients with two to three conditions; and 32.5% having SUD among patients with 4-9 conditions). Chronic conditions were associated with increased odds of SUDs. For all SUD groups, hospitalization was more prevalent among patients with SUD than those without it; prevalence of hospitalization increased with the number of comorbid chronic conditions. CONCLUSIONS:Findings reveal a striking pattern of multicomorbidity of SUD and chronic diseases and its positive association with hospitalization. Behavioral healthcare integration should consider efforts to assess and treat comorbid SUD and chronic diseases, especially among adults with multiple chronic conditions.Item Open Access Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy.(Substance abuse, 2023-10) Jarrett, Jennie B; Bratberg, Jeffrey; Burns, Anne L; Cochran, Gerald; DiPaula, Bethany A; Legreid Dopp, Anna; Elmes, Abigail; Green, Traci C; Hill, Lucas G; Homsted, Felicity; Hsia, Stephanie L; Matthews, Michele L; Ghitza, Udi E; Wu, Li-Tzy; Bart, GavinIn the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD. The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes. Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.Item Open Access Substance use and mental diagnoses among adults with and without type 2 diabetes: Results from electronic health records data.(Drug and alcohol dependence, 2015-11) Wu, Li-Tzy; Ghitza, Udi E; Batch, Bryan C; Pencina, Michael J; Rojas, Leoncio Flavio; Goldstein, Benjamin A; Schibler, Tony; Dunham, Ashley A; Rusincovitch, Shelley; Brady, Kathleen TBACKGROUND:Comorbid diabetes and substance use diagnoses (SUD) represent a hazardous combination, both in terms of healthcare cost and morbidity. To date, there is limited information about the association of SUD and related mental disorders with type 2 diabetes mellitus (T2DM). METHODS:We examined the associations between T2DM and multiple psychiatric diagnosis categories, with a focus on SUD and related psychiatric comorbidities among adults with T2DM. We analyzed electronic health record (EHR) data on 170,853 unique adults aged ≥18 years from the EHR warehouse of a large academic healthcare system. Logistic regression analyses were conducted to estimate the strength of an association for comorbidities. RESULTS:Overall, 9% of adults (n=16,243) had T2DM. Blacks, Hispanics, Asians, and Native Americans had greater odds of having T2DM than whites. All 10 psychiatric diagnosis categories were more prevalent among adults with T2DM than among those without T2DM. Prevalent diagnoses among adults with T2MD were mood (21.22%), SUD (17.02%: tobacco 13.25%, alcohol 4.00%, drugs 4.22%), and anxiety diagnoses (13.98%). Among adults with T2DM, SUD was positively associated with mood, anxiety, personality, somatic, and schizophrenia diagnoses. CONCLUSIONS:We examined a large diverse sample of individuals and found clinical evidence of SUD and psychiatric comorbidities among adults with T2DM. These results highlight the need to identify feasible collaborative care models for adults with T2DM and SUD related psychiatric comorbidities, particularly in primary care settings, that will improve behavioral health and reduce health risk.Item Open Access Substance use disorders and medical comorbidities among high-need, high-risk patients with diabetes.(Drug and alcohol dependence, 2018-05) Wu, Li-Tzy; Ghitza, Udi E; Zhu, He; Spratt, Susan; Swartz, Marvin; Mannelli, PaoloThe majority of the U.S. healthcare resources are utilized by a small population characterized as high-risk, high-need persons with complex care needs (e.g., adults with multiple chronic conditions). Substance use disorders (SUDs) and mental health disorders (MHDs) are a driver of poor health and additional healthcare costs, but they are understudied among high-need patients.We examine the prevalence and correlates of SUDs and MHDs among adults with high-risk diabetes, who are patients at the top 10% risk score for developing poor outcomes (hospital admission or death).A risk algorithm developed from Duke University Health System electronic health records (EHRs) data was used to identify patients with high-risk diabetes for targeting home-based primary care. The EHR data of the 263 patients with high-risk diabetes were analyzed to understand patterns of SUDs and MHDs to inform care-coordinating efforts.Both SUDs (any SUD 48.3%, alcohol 12.5%, tobacco 38.8%, drug 23.2%) and MHDs (any MHD 74.9%, mood 53.2%, sleep 37.3%, anxiety 32.7%, schizophrenia/psychotics/delusional 14.8%, dementia/delirium/amnestic/cognitive 14.4%, adjustment 9.1%) were prevalent. Overall, 81.7% of the sample had SUD or MHD. Elevated odds of SUD were noted among men (tobacco, alcohol) and those who were never-married (alcohol, cannabis). African-American race (vs. other race/ethnicity) was associated with lower odds of anxiety disorders.While data are limited to one large academic health system, they provide clinical evidence revealing that 82% of patients with high-risk diabetes had SUD and/or MHD recorded in their EHRs, highlighting a need for developing service models to optimize high-risk care.Item Open Access The opioid overdose epidemic: opportunities for pharmacists.(Subst Abuse Rehabil, 2017) Wu, Li-Tzy; Ghitza, Udi E; Burns, Anne L; Mannelli, PaoloItem Open Access Using electronic health record data for substance use Screening, Brief Intervention, and Referral to Treatment among adults with type 2 diabetes: Design of a National Drug Abuse Treatment Clinical Trials Network study.(Contemp Clin Trials, 2016-01) Wu, Li-Tzy; Brady, Kathleen T; Spratt, Susan E; Dunham, Ashley A; Heidenfelder, Brooke; Batch, Bryan C; Lindblad, Robert; VanVeldhuisen, Paul; Rusincovitch, Shelley A; Killeen, Therese K; Ghitza, Udi EBACKGROUND: The Affordable Care Act encourages healthcare systems to integrate behavioral and medical healthcare, as well as to employ electronic health records (EHRs) for health information exchange and quality improvement. Pragmatic research paradigms that employ EHRs in research are needed to produce clinical evidence in real-world medical settings for informing learning healthcare systems. Adults with comorbid diabetes and substance use disorders (SUDs) tend to use costly inpatient treatments; however, there is a lack of empirical data on implementing behavioral healthcare to reduce health risk in adults with high-risk diabetes. Given the complexity of high-risk patients' medical problems and the cost of conducting randomized trials, a feasibility project is warranted to guide practical study designs. METHODS: We describe the study design, which explores the feasibility of implementing substance use Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adults with high-risk type 2 diabetes mellitus (T2DM) within a home-based primary care setting. Our study includes the development of an integrated EHR datamart to identify eligible patients and collect diabetes healthcare data, and the use of a geographic health information system to understand the social context in patients' communities. Analysis will examine recruitment, proportion of patients receiving brief intervention and/or referrals, substance use, SUD treatment use, diabetes outcomes, and retention. DISCUSSION: By capitalizing on an existing T2DM project that uses home-based primary care, our study results will provide timely clinical information to inform the designs and implementation of future SBIRT studies among adults with multiple medical conditions.