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Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial

Wang, Jing; Doan, Lisa V; Axelrod, Deborah; Rotrosen, John; Wang, Binhuan; Park, Hyung G; Edwards, Robert R; Curatolo, Michele; Jackman, Carina; Perez, Raven; ,
BACKGROUND:Mastectomies are commonly performed and strongly associated with chronic postsurgical pain (CPSP), more specifically termed postmastectomy pain syndrome (PMPS), with 25-60% of patients reporting pain 3 months after surgery. PMPS interferes with function, recovery, and compliance with adjuvant therapy. Importantly, it is associated with chronic opioid use, as a recent study showed that 1 in 10 patients continue to use opioids at least 3 months after curative surgery. The majority of PMPS patients are women, and, over the past 10 years, women have outpaced men in the rate of growth in opioid dependence. Standard perioperative multimodal analgesia is only modestly effective in prevention of CPSP. Thus, interventions to reduce CPSP and PMPS are urgently needed. Ketamine is well known to improve pain and reduce opioid use in the acute postoperative period. Additionally, ketamine has been shown to control mood in studies of anxiety and depression. By targeting acute pain and improving mood in the perioperative period, ketamine may be able to prevent the development of CPSP. METHODS:Ketamine analgesia for long-lasting pain relief after surgery (KALPAS) is a phase 3, multicenter, randomized, placebo-controlled, double-blind trial to study the effectiveness of ketamine in reducing PMPS. The study compares continuous perioperative ketamine infusion vs single-dose ketamine in the postanesthesia care unit vs placebo for reducing PMPS. Participants are followed for 1 year after surgery. The primary outcome is pain at the surgical site at 3 months after the index surgery as assessed with the Brief Pain Inventory-short form pain severity subscale. DISCUSSION/CONCLUSIONS:This project is part of the NIH Helping to End Addiction Long-term (HEAL) Initiative, a nationwide effort to address the opioid public health crisis. This study can substantially impact perioperative pain management and can contribute significantly to combatting the opioid epidemic. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT05037123. Registered on September 8, 2021.
PMCID:10797799
PMID: 38243266
ISSN: 1745-6215
CID: 5624462

Individual-Level Risk Prediction of Return to Use During Opioid Use Disorder Treatment

Luo, Sean X; Feaster, Daniel J; Liu, Ying; Balise, Raymond R; Hu, Mei-Chen; Bouzoubaa, Layla; Odom, Gabriel J; Brandt, Laura; Pan, Yue; Hser, Yih-Ing; VanVeldhuisen, Paul; Castillo, Felipe; Calderon, Anna R; Rotrosen, John; Saxon, Andrew J; Weiss, Roger D; Wall, Melanie; Nunes, Edward V
IMPORTANCE/UNASSIGNED:No existing model allows clinicians to predict whether patients might return to opioid use in the early stages of treatment for opioid use disorder. OBJECTIVE/UNASSIGNED:To develop an individual-level prediction tool for risk of return to use in opioid use disorder. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This decision analytical model used predictive modeling with individual-level data harmonized in June 1, 2019, to October 1, 2022, from 3 multicenter, pragmatic, randomized clinical trials of at least 12 weeks' duration within the National Institute on Drug Abuse Clinical Trials Network (CTN) performed between 2006 and 2016. The clinical trials covered a variety of treatment settings, including federally licensed treatment sites, physician practices, and inpatient treatment facilities. All 3 trials enrolled adult participants older than 18 years, with broad pragmatic inclusion and few exclusion criteria except for major medical and unstable psychiatric comorbidities. INTERVENTION/UNASSIGNED:All participants received 1 of 3 medications for opioid use disorder: methadone, buprenorphine, or extended-release naltrexone. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Predictive models were developed for return to use, which was defined as 4 consecutive weeks of urine drug screen (UDS) results either missing or positive for nonprescribed opioids by week 12 of treatment. RESULTS/UNASSIGNED:The overall sample included 2199 trial participants (mean [SD] age, 35.3 [10.7] years; 728 women [33.1%] and 1471 men [66.9%]). The final model based on 4 predictors at treatment entry (heroin use days, morphine- and cocaine-positive UDS results, and heroin injection in the past 30 days) yielded an area under the receiver operating characteristic curve (AUROC) of 0.67 (95% CI, 0.62-0.71). Adding UDS in the first 3 treatment weeks improved model performance (AUROC, 0.82; 95% CI, 0.78-0.85). A simplified score (CTN-0094 OUD Return-to-Use Risk Score) provided good clinical risk stratification wherein patients with weekly opioid-negative UDS results in the 3 weeks after treatment initiation had a 13% risk of return to use compared with 85% for those with 3 weeks of opioid-positive or missing UDS results (AUROC, 0.80; 95% CI, 0.76-0.84). CONCLUSIONS AND RELEVANCE/UNASSIGNED:The prediction model described in this study may be a universal risk measure for return to opioid use by treatment week 3. Interventions to prevent return to regular use should focus on this critical early treatment period.
PMCID:10551817
PMID: 37792357
ISSN: 2168-6238
CID: 5625732

Retention and critical outcomes among new methadone maintenance patients following extended take-home reforms: a retrospective observational cohort study

Williams, Arthur Robin; Krawczyk, Noa; Hu, Mei-Chen; Harpel, Lexa; Aydinoglo, Nicole; Cerda, Magdalena; Rotrosen, John; Nunes, Edward V
BACKGROUND/UNASSIGNED:Approximately 1800 opioid treatment programs (OTPs) in the US dispense methadone to upwards of 400,000 patients with opioid use disorder (OUD) annually, operating under longstanding highly restrictive guidelines. OTPs were granted novel flexibilities beginning March 15, 2020, allowing for reduced visit frequency and extended take-home doses to minimize COVID exposure with great variation across states and sites. We sought to use electronic health records to compare retention in treatment, opioid use, and adverse events among patients newly entering methadone maintenance in the post-reform period in comparison with year-ago, unexposed, controls. METHODS/UNASSIGNED:Retrospective observational cohort study across 9 OTPs, geographically dispersed, in the National Institute of Drug Abuse (NIDA) Clinical Trials Network. Newly enrolled patients between April 15 and October 14, 2020 (post-COVID, reform period) v. March 15-September 14, 2019 (pre-COVID, control period) were assessed. The primary outcome was 6-month retention. Secondary outcomes were opioid use and adverse events including emergency department visits, hospitalizations, and overdose. FINDINGS/UNASSIGNED: INTERPRETATION/UNASSIGNED:Policies allowing for extended take-home schedules were not associated with worse retention or adverse events despite slightly elevated rates of measured opioid use while in care. Relaxed guidelines were not associated with measurable increased harms and findings could inform future studies with prospective trials. FUNDING/UNASSIGNED:USDHHSNIDACTNUG1DA013035-15.
PMCID:10751716
PMID: 38152421
ISSN: 2667-193x
CID: 5623252

Clinical and psychosocial outcomes by sex among individuals prescribed buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX) for opioid use disorder

Paschen-Wolff, Margaret; Greenfield, Shelly F; Kathryn McHugh, R; Burlew, Kathleen; Pavlicova, Martina; Choo, Tse-Hwei; Barbosa-Leiker, Celestina; Ruglass, Lesia M; Mennenga, Sarah; Rotrosen, John; Nunes, Edward V; Campbell, Aimee N C
BACKGROUND AND OBJECTIVES:Limited research has explored sex differences in opioid use disorder medication (MOUD) treatment outcomes. The purpose of this study was to examine MOUD initiation onto buprenorphine-naloxone (BUP-NX) versus extended-release naltrexone (XR-NTX) by sex, and sex differences in clinical and psychosocial outcomes. METHODS:Using data from a 24-week open-label comparative effectiveness trial of BUP-NX or XR-NTX, this study examined MOUD initiation (i.e., receiving a minimum one XR-NTX injection or first BUP-NX dose) and 24-week self-report outcomes. We used regression models to estimate the probability of MOUD initiation failure among the intent-to-treat sample (N = 570), and the main and interaction effects of sex on outcomes of interest among the subsample of participants who successfully initiated MOUD (n = 474). RESULTS:In the intent-to-treat sample, the odds of treatment initiation failure were not significantly different by sex. In the subsample of successful MOUD initiates, the effect of treatment on employment at week 24 was significantly moderated by sex (p = .003); odds of employment were not significantly different among males by MOUD type; females randomized to XR-NTX versus BUP-NX had 4.63 times greater odds of employment (p < .001). Males had significantly lower odds of past 30-day exchanging sex for drugs versus females (adjusted odds ratios [aOR] = 0.10, p = .004), controlling for treatment and baseline outcomes. DISCUSSION AND CONCLUSIONS:Further research should explore how to integrate employment support into OUD treatment to improve patient outcomes, particularly among women. SCIENTIFIC SIGNIFICANCE:The current study addressed gaps in the literature by examining sex differences in MOUD initiation and diverse treatment outcomes in a large, national sample.
PMID: 37583120
ISSN: 1521-0391
CID: 5607192

Risks of returning to opioid use at treatment entry and early in opioid use disorder treatment: Role of non-opioid substances

Castillo, Felipe; Hu, Mei-Chen; Liu, Ying; Balise, Raymond R; Weiss, Roger D; Rotrosen, John; Nunes, Edward V; Saxon, Andrew J; Feaster, Daniel J; Luo, Sean X
OBJECTIVE:Patients in treatment with medications for opioid use disorder (MOUD) often report use of other substances in addition to opioids. Few studies exist that examine the relationship between use at treatment entry and early non-opioid use in opioid treatment outcome. METHODOLOGY/METHODS:We combined and harmonized three randomized, controlled MOUD clinical trials from the National Institutes of Drug Abuse (NIDA) Clinical Trials Network (CTN) (N=2197) and investigated the association of non-opioid substance use at treatment entry and during early treatment with a return to opioid use. The trials compared MOUD treatment (buprenorphine, methadone, extended-release naltrexone) in populations with opioid use disorder (OUD). Non-opioid substances were identified through harmonizing self-reported use. The primary outcomes were markers of return to opioid use by 12 weeks. RESULTS:When treatment cohorts were adjusted, no association between self-reported treatment entry use of non-opioid substances and week-12 opioid use was detected. During the first month of treatment, higher use of cocaine (OR 1.41 [1.18-1.69]) and amphetamine (OR 1.70 [1.27-2.26]) was found to be associated with higher likelihood of illicit opioid use by week 12. Exploratory analyses of potential treatment cohort-by-predictor interactions showed that those with heavier cocaine use had a lower rate of returning to opioid use in the extended-release naltrexone group than in the methadone group. CONCLUSION/CONCLUSIONS:Substance use other than opioids at treatment entry is not associated with relapse. Use of cocaine or amphetamines during the first few weeks of MOUD treatment may signal a worse outcome, suggesting a need for additional interventions.
PMCID:10712265
PMID: 37604012
ISSN: 1879-0046
CID: 5598372

Implementation of substance use screening in rural federally-qualified health center clinics identified high rates of unhealthy alcohol and cannabis use among adult primary care patients

McNeely, Jennifer; McLeman, Bethany; Gardner, Trip; Nesin, Noah; Amarendran, Vijay; Farkas, Sarah; Wahle, Aimee; Pitts, Seth; Kline, Margaret; King, Jacquie; Rosa, Carmen; Marsch, Lisa; Rotrosen, John; Hamilton, Leah
BACKGROUND:Screening for substance use in rural primary care clinics faces unique challenges due to limited resources, high patient volumes, and multiple demands on providers. To explore the potential for electronic health record (EHR)-integrated screening in this context, we conducted an implementation feasibility study with a rural federally-qualified health center (FQHC) in Maine. This was an ancillary study to a NIDA Clinical Trials Network study of screening in urban primary care clinics (CTN-0062). METHODS:Researchers worked with stakeholders from three FQHC clinics to define and implement their optimal screening approach. Clinics used the Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool, completed on tablet computers in the waiting room, and results were immediately recorded in the EHR. Adult patients presenting for annual preventive care visits, but not those with other visit types, were eligible for screening. Data were analyzed for the first 12 months following implementation at each clinic to assess screening rates and prevalence of reported unhealthy substance use, and documentation of counseling using an EHR-integrated clinical decision support tool, for patients screening positive for moderate-high risk alcohol or drug use. RESULTS:Screening was completed by 3749 patients, representing 93.4% of those with screening-eligible annual preventive care visits, and 18.5% of adult patients presenting for any type of primary care visit. Screening was self-administered in 92.9% of cases. The prevalence of moderate-high risk substance use detected on screening was 14.6% for tobacco, 30.4% for alcohol, 10.8% for cannabis, 0.3% for illicit drugs, and 0.6% for non-medical use of prescription drugs. Brief substance use counseling was documented for 17.4% of patients with any moderate-high risk alcohol or drug use. CONCLUSIONS:Self-administered EHR-integrated screening was feasible to implement, and detected substantial alcohol, cannabis, and tobacco use in rural FQHC clinics. Counseling was documented for a minority of patients with moderate-high risk use, possibly indicating a need for better support of primary care providers in addressing substance use. There is potential to broaden the reach of screening by offering it at routine medical visits rather than restricting to annual preventive care visits, within these and other rural primary care clinics.
PMCID:10510292
PMID: 37726839
ISSN: 1940-0640
CID: 5610272

Implementing Programs to Initiate Buprenorphine for Opioid Use Disorder Treatment in High-Need, Low-Resource Emergency Departments: A Nonrandomized Controlled Trial

McCormack, Ryan P; Rotrosen, John; Gauthier, Phoebe; D'Onofrio, Gail; Fiellin, David A; Marsch, Lisa A; Novo, Patricia; Liu, David; Edelman, E Jennifer; Farkas, Sarah; Matthews, Abigail G; Mulatya, Caroline; Salazar, Dagmar; Wolff, Jeremy; Knight, Randolph; Goodman, William; Williams, Joseph; Hawk, Kathryn
STUDY OBJECTIVE/OBJECTIVE:We hypothesized that implementation facilitation would enable us to rapidly and effectively implement emergency department (ED)-initiated buprenorphine programs in rural and urban settings with high-need, limited resources and dissimilar staffing structures. METHODS:This multicenter implementation study employed implementation facilitation using a participatory action research approach to develop, introduce, and refine site-specific clinical protocols for ED-initiated buprenorphine and referral in 3 EDs not previously initiating buprenorphine. We assessed feasibility, acceptability, and effectiveness by triangulating mixed-methods formative evaluation data (focus groups/interviews and pre/post surveys involving staff, patients, and stakeholders), patients' medical records, and 30-day outcomes from a purposive sample of 40 buprenorphine-receiving patient-participants who met research eligibility criteria (English-speaking, medically stable, locator information, nonprisoners). We estimated the primary implementation outcome (proportion receiving ED-initiated buprenorphine among candidates) and the main secondary outcome (30-day treatment engagement) using Bayesian methods. RESULTS:Within 3 months of initiating the implementation facilitation activities, each site implemented buprenorphine programs. During the 6-month programmatic evaluation, there were 134 ED-buprenorphine candidates among 2,522 encounters involving opioid use. A total of 52 (41.6%) practitioners initiated buprenorphine administration to 112 (85.1%; 95% confidence interval [CI] 79.7% to 90.4%) unique patients. Among 40 enrolled patient-participants, 49.0% (35.6% to 62.5%) were engaged in addiction treatment 30 days later (confirmed); 26 (68.4%) reported attending one or more treatment visits; there was a 4-fold decrease in self-reported overdose events (odds ratio [OR] 4.03; 95% CI 1.27 to 12.75). The ED clinician readiness increased by a median of 5.02 (95% CI: 3.56 to 6.47) from 1.92/10 to 6.95/10 (n(pre)=80, n(post)=83). CONCLUSIONS:The implementation facilitation enabled us to effectively implement ED-based buprenorphine programs across heterogeneous ED settings rapidly, which was associated with promising implementation and exploratory patient-level outcomes.
PMID: 37140493
ISSN: 1097-6760
CID: 5504462

Misclassification of overdose events in the X:BOT study - Authors' reply [Letter]

Lee, Joshua D; Nunes, Edward V; Van Veldhuisen, Paul; Lindblad, Robert; Rotrosen, John
PMID: 37480935
ISSN: 1474-547x
CID: 5536282

Impact of Medication-Based Treatment on Health Care Utilization Among Individuals With Opioid Use Disorder

Gopaldas, Manesh; Wenzel, Kevin; Campbell, Aimee N C; Jalali, Ali; Fishman, Marc; Rotrosen, John; Nunes, Edward V; Murphy, Sean M
OBJECTIVE/UNASSIGNED:This study evaluated the association between medication for opioid use disorder (MOUD) and health care utilization over time among a sample of treatment-seeking individuals with opioid use disorder. In contrast to previous studies, this study used a novel measure of MOUD adherence, more comprehensive utilization data, and analyses that controlled for detailed individual and social determinants of health. METHODS/UNASSIGNED:This study was a secondary analysis of a comparative effectiveness trial (N=570) of extended-release naltrexone versus buprenorphine-naloxone. The outcome of interest was usage of nonstudy acute care, inpatient and outpatient addiction services, and other outpatient services across 36 weeks of assessment. Adherence (percentage of days taking MOUD) was defined as low (<20%), medium (≥20% but <80%), or high (≥80%). A two-part model evaluated the probability of utilizing a resource and the quantity (utilization days) of the resource consumed. A time-varying approach was used to examine the effect of adherence in a given month on utilization in the same month, with analyses controlling for a wide range of person-level characteristics. RESULTS/UNASSIGNED:Participants with high adherence (vs. low) were significantly less likely to use inpatient addiction (p<0.001) and acute care (p<0.001) services and significantly more likely to engage in outpatient addiction (p=0.045) and other outpatient (p=0.042) services. CONCLUSIONS/UNASSIGNED:These findings reinforce the understanding that greater MOUD adherence is associated with reduced usage of high-cost health services and increased usage of outpatient care. The results further suggest the need for enhanced access to MOUD and for interventions that improve adherence.
PMID: 37337675
ISSN: 1557-9700
CID: 5542592

Homelessness and Treatment Outcomes Among Black Adults With Opioid Use Disorder: A Secondary Analysis of X:BOT

Justen, Marissa; Scodes, Jennifer; Pavlicova, Martina; Choo, Tse-Hwei; Gopaldas, Manesh; Haeny, Angela; Opara, Onumara; Rhee, Taeho Greg; Rotrosen, John; Nunes, Edward V; Hawk, Kathryn; Edelman, E Jennifer
OBJECTIVE:We sought to identify the sociodemographic and clinical characteristics associated with homelessnesss, and explore the relationship between homelessnesss and treatment outcomes among Black individuals. METHODS:This is a secondary analysis of the subgroup of Black participants (n = 73) enrolled in "X:BOT," a 24-week multisite randomized clinical trial comparing the effectiveness of extended-release naltrexone versus sublingual buprenorphine-naloxone (n = 570). Outcomes included medication initiation, return to extramedical use of opioids assessed by both self-report and urine toxicology, and engagement in medications for opioid use disorder (MOUD) treatment at 28 weeks postrandomization. Descriptive statistics were performed. RESULTS:Black participants were mostly unmarried and male, and about a third were aged 21-30 years. Among people experiencing homelessnesss, more were uninsured (45.5% [10/22] vs 19.6% [10/51]), unemployed (77.3% [17/22] vs 64.7% [33/51]), and reported alcohol (40.9% [9/22] vs 23.5% [12/51]) and sedative use (54.5% [12/22] vs 17.6% [9/51]) within the previous 30 days. Compared with housed Black individuals, a slightly higher proportion of Black individuals experiencing homelessnesss successfully initiated study medication (81.1% [18/22] vs 72.6% [37/51]); similar proportions returned to opioid use during the trial (68.2% [15/22] vs 68.6% [35/51]) and were engaged in MOUD at 28 weeks after trial entry (72.2% [13/18] vs 69.7% [23/33]) among participants located for follow-up. CONCLUSIONS:These descriptive results among Black patients participating in a trial of MOUD suggest that efficacious MOUD is possible despite homelessnesss with additional clinical supports such as those provided by a clinical trial.
PMCID:10323031
PMID: 37579110
ISSN: 1935-3227
CID: 5609332