Drug Abuse Clinical Trials Network Research Articles

Peer Intervention to Link Overdose Survivors to Treatment (PILOT): Protocol for a Multisite, Randomized Controlled Trial Conducted Within the National Institute on Drug Abuse Clinical Trials Network.

The increase in opioid-related overdoses has caused a decrease in average life expectancy, highlighting the need for effective interventions to reduce overdose risk and prevent subsequent overdoses. Peer support specialists (PSSs) offer an appealing strategy to engage overdose survivors and reduce overdose risk, but randomized controlled trials are needed to formalize peer-led interventions and evaluate their effectiveness. This National Institute on Drug Abuse Clinical Trials Network (CTN) study is a multisite, prospective, pilot randomized (1:1) controlled trial (CTN protocol 0107) that aims to evaluate the effectiveness of an emergency department (ED)-initiated, peer-delivered intervention tailored for opioid overdose survivors (PeerIntervention to Link Overdose survivors toTreatment [PILOT]), compared with treatment as usual (TAU). This study evaluates the effectiveness of the 6-month, PSS-led PILOT intervention compared with TAU on the primary outcome of reducing overdose risk behavior 6 months after enrollment. Adults (aged ≥18 years; N=150) with a recent opioid-related overdose were identified and approached in the ED. Participants were screened and enrolled, either in the ED or within 7 days of ED discharge at research offices or in the community and then asked to complete study visits at months 1, 3, 6 (end of intervention), and 7 (follow-up). Participants were enrolled at 3 study sites in the United States: Greenville, South Carolina; Youngstown, Ohio; and Everett, Washington. Participants randomized to the PILOT intervention received a 6-month, PSS-led intervention tailored to each participant's goals to reduce their overdose risk behavior (eg, overdose harm reduction, housing, medical, and substance use treatment or recovery goals). Participants randomized to TAU received standard-of-care overdose materials, education, and services provided through the participating EDs. This paper describes the study protocol and procedures, explains the design and inclusion and exclusion decisions, and provides details of the peer-led PILOT intervention and supervision of PILOT PSSs. Study enrollment opened in December 2021 and was closed in July 2023. A total of 150 participants across 3 sites were enrolled in the study, meeting the proposed sample size for the trial. Primary and secondary analyses are underway and expected to be published in early 2025. There is an urgent need to better understand the characteristics of overdose survivors presenting to the ED and for rigorous trials evaluating the effectiveness of PSS-led interventions on engaging overdose survivors and reducing overdose risk. Results from this pilot randomized controlled trial will provide a description of the characteristics of overdose survivors presenting to the ED; outline the implementation of PSS services research in ED settings, including PSS implementation of PSS supervision and activity tracking; and inform ED-initiated PSS-led overdose risk reduction interventions and future research to better understand the implementation and efficacy of these interventions. ClinicalTrials.gov NCT05123027; https://clinicaltrials.gov/study/NCT05123027. DERR1-10.2196/60277.

W77 - Peer Intervention to Link Overdose Survivors to Treatment (PILOT): Study Protocol of a Multi-Site, Randomized Controlled Trial in the National Institute on Drug Abuse Clinical Trials Network

W77 - Peer Intervention to Link Overdose Survivors to Treatment (PILOT): Study Protocol of a Multi-Site, Randomized Controlled Trial in the National Institute on Drug Abuse Clinical Trials Network

Characterization of peer support services for substance use disorders in 11 US emergency departments in 2020: findings from a NIDA clinical trials network site selection process.

Emergency departments (ED) are incorporating Peer Support Specialists (PSSs) to help with patient care for substance use disorders (SUDs). Despite rapid growth in this area, little is published regarding workflow, expectations of the peer role, and core components of the PSS intervention. This study describes these elements in a national sample of ED-based peer support intervention programs. A survey was conducted to assess PSS site characteristics as part of site selection process for a National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) evaluating PSS effectiveness, Surveys were distributed to clinical sites affiliated with the 16 CTN nodes. Surveys were completed by a representative(s) of the site and collected data on the PSS role in the ED including details regarding funding and certification, services rendered, role in medications for opioid use disorder (MOUD) and naloxone distribution, and factors impacting implementation and maintenance of ED PSS programs. Quantitative data was summarized with descriptive statistics. Free-text fields were analyzed using qualitative content analysis. A total of 11 surveys were completed, collected from 9 different states. ED PSS funding was from grants (55%), hospital funds (46%), peer recovery organizations (27%) or other (18%). Funding was anticipated to continue for a mean of 16months (range 12 to 36months). The majority of programs provided "general recovery support (81%) Screening, Brief Intervention, and Referral to Treatment (SBIRT) services (55%), and assisted with naloxone distribution to ED patients (64%). A minority assisted with ED-initiated buprenorphine (EDIB) programs (27%). Most (91%) provided services to patients after they were discharged from the ED. Barriers to implementation included lack of outpatient referral sources, barriers to initiating MOUD, stigma at the clinician and system level, and lack of ongoing PSS availability due to short-term grant funding. The majority of ED-based PSSs were funded through time-limited grants, and short-term grant funding was identified as a barrier for ED PSS programs. There was consistency among sites in the involvement of PSSs in facilitation of transitions of SUD care, coordination of follow-up after ED discharge, and PSS involvement in naloxone distribution.

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

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. 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. 821 individuals were newly admitted in the post-COVID and year-ago control periods, average age of 38.3 (SD 11.1), 58.9% male. The only difference across pre- and post-reform groups was the prevalence of psychostimulant use disorder (25.7% vs 32.9%, p=0.02). Retention was non-inferior (60.0% vs 60.1%) as were hazards of adverse events in the aggregate (X2 (1)=0.55, p=0.46) in the post-COVID period. However, rates of month-level opioid use were higher among post-COVID intakes compared to pre-COVID controls (64.8% vs 51.1%, p<0.001). Moderator analyses accounting for stimulant use and site-level variation in take-home schedules did not change findings. 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. USDHHSNIDACTNUG1DA013035-15.

The Spanish language version of the TAPS tool: protocol for a validation and implementation study in primary care

BackgroundThe TAPS Tool (“Tobacco, Alcohol, Prescription drug, and illicit Substance use”) is a screening and brief assessment for detecting unhealthy substance use in healthcare settings that was developed by the National Institute on Drug Abuse Clinical Trials Network and validated in a multisite study. Our team developed a Spanish language version of the TAPS Tool that supports provider- and self-administration screening using a mobile/web-based platform, the TAPS Electronic Spanish Platform (TAPS-ESP).MethodsThis article describes the protocol and rationale for a study to validate the TAPS-ESP in a sample of Spanish-speaking primary care patients recruited from a network of community-based clinics in Texas (target N = 1,000). The TAPS-ESP will be validated against established substance use disorder diagnostic measures, alternative screening tools, and substance use biomarkers. The study will subsequently examine barriers and facilitators to screening with the TAPS-ESP from a provider workflow perspective using qualitative interviews with providers.DiscussionValidating a Spanish language version of the TAPS Tool could expand access to evidence-based, linguistically accurate, and culturally relevant substance use screening and brief assessment for an underserved health disparity population.Trial registration: The study was registered with www.clinicaltrials.gov: NCT05476588, 07/22/2022.

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

No existing model allows clinicians to predict whether patients might return to opioid use in the early stages of treatment for opioid use disorder. To develop an individual-level prediction tool for risk of return to use in opioid use disorder. 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. All participants received 1 of 3 medications for opioid use disorder: methadone, buprenorphine, or extended-release naltrexone. 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. 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). 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.

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

ObjectivePatients 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. MethodologyWe 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. ResultsWhen 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. ConclusionSubstance 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.

Lessons learned and future directions: A scoping review of American Indian and Alaska Native participants in the National Drug Abuse Treatment Clinical Trials Network

IntroductionAmerican Indian and Alaska Native (AI/AN) populations are disproportionately affected by substance use disorders (SUDs) and related health disparities in contrast to other ethnoracial groups in the United States. Over the past 20 years, substantial resources have been allocated to the National Institute on Drug Abuse Clinical Trials Network (CTN) to disseminate and implement effective SUD treatments in communities. However, we know little about how these resources have benefitted AI/AN peoples with SUD who arguably experience the greatest burden of SUDs. This review aims to determine lessons learned about AI/AN substance use and treatment outcomes in the CTN and the role of racism and Tribal identity. MethodWe conducted a scoping review informed by the Joanna Briggs framework and PRISMA Extension for Scoping Reviews checklist and explanation. The study team conducted the search strategy within the CTN Dissemination Library and nine additional databases for articles published between 2000 and 2021. The review included studies if they reported results for AI/AN participants. Two reviewers determined study eligibility. ResultsA systematic search yielded 13 empirical articles and six conceptual articles. Themes from the 13 empirical articles included: (1) Tribal Identity: Race, Culture, and Discrimination; (2) Treatment Engagement: Access and Retention; (3) Comorbid Conditions; (4) HIV/Risky Sexual Behaviors; and (5) Dissemination. The most salient theme was Tribal Identity: Race, Culture, and Discrimination, which was present in all articles that included a primary AI/AN sample (k = 8). Themes assessed but not identified for AI/AN peoples were Harm Reduction, Measurement Equivalence, Pharmacotherapy, and Substance Use Outcomes. The conceptual contributions used AI/AN CTN studies as exemplars of community-based and Tribal participatory research (CBPR/TPR). ConclusionCTN studies conducted with AI/AN communities demonstrate culturally congruent methods, including CBPR/TPR strategies; consideration/assessment of cultural identity, racism, and discrimination; and CBPR/TPR informed dissemination plans. Although important efforts are underway to increase AI/AN participation in the CTN, future research would benefit from strategies to increase participation of this population. Such strategies include reporting AI/AN subgroup data; addressing issues of cultural identity and experiences of racism; and adopting an overall effort for research aimed at understanding barriers to treatment access, engagement, utilization, retention, and outcomes for both treatment and research disparities for AI/AN populations.

National Institute on Drug Abuse Clinical Trials Network Meeting Report: Advancing Emergency Department Initiation of Buprenorphine for Opioid Use Disorder

Opioid use disorder and opioid overdose deaths are a major public health crisis, yet highly effective evidence-based treatments are available that reduce morbidity and mortality. One such treatment, buprenorphine, can be initiated in the emergency department (ED). Despite evidence of efficacy and effectiveness for ED-initiated buprenorphine, universal uptake remains elusive. On November 15 and 16, 2021, the National Institute on Drug Abuse Clinical Trials Network convened a meeting of partners, experts, and federal officers to identify research priorities and knowledge gaps for ED-initiated buprenorphine. Meeting participants identified research and knowledge gaps in 8 categories, including ED staff and peer-based interventions; out-of-hospital buprenorphine initiation; buprenorphine dosing and formulations; linkage to care; strategies for scaling ED-initiated buprenorphine; the effect of ancillary technology-based interventions; quality measures; and economic considerations. Additional research and implementation strategies are needed to enhance adoption into standard emergency care and improve patient outcomes.

Optimally Choosing Medication Type for Patients With Opioid Use Disorder.

Patients with opioid use disorder (OUD) tend to get assigned to one of 3 medications based on the treatment program to which the patient presents (e.g., opioid treatment programs tend to treat patients with methadone, while office-based practices tend to prescribe buprenorphine). It is possible that optimally matching patients with treatment type would reduce the risk of return to regular opioid use (RROU). We analyzed data from 3 comparative effectiveness trials from the US National Institute on Drug Abuse Clinical Trials Network (CTN0027, 2006-2010; CTN0030, 2006-2009; and CTN0051 2014-2017), in which patients with OUD (n= 1,459) were assigned to treatment with either injection extended-release naltrexone (XR-NTX), sublingual buprenorphine-naloxone (BUP-NX), or oral methadone. We learned an individualized rule by which to assign medication type such that risk of RROU during 12 weeks of treatment would be minimized, and then estimated the amount by which RROU risk could be reduced if the rule were applied. Applying our estimated treatment rule would reduce risk of RROU compared with treating everyone with methadone (relative risk (RR)= 0.79, 95% confidence interval (CI): 0.60, 0.97) or treating everyone with XR-NTX (RR= 0.71, 95% CI: 0.47, 0.96). Applying the estimated treatment rule would have resulted in a similar risk of RROU to that of with treating everyone with BUP-NX (RR= 0.92, 95% CI: 0.73, 1.11).

Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study

BackgroundA lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.Methods/designOverseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.DiscussionThis initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.Trial registrationhttp://www.comet-initiative.org/Studies/Details/1579

Prevalence of obesity among U.S. population with substance dependence

AimTo investigate associations between substance dependence and obesity. MethodsObesity (body mass index ≥ 30 kg/m2) status and the status of dependence on heroin, stimulant, marijuana, nicotine and alcohol (past-month status for nicotine and past-year status for all others) were identified from the U.S. National Survey on Drug Use and Health (NSDUH, 2015–2017) datasets. SAS Surveylogistic regression was used to estimate adjusted odds ratio (AOR) for the association between each substance dependence and obesity, adjusting for potentially confounding effects of sociodemographic factors and health condition. ResultsIt was estimated that 10.6 % of noninstitutional U.S. residents aged 12 years or older were nicotine-dependent, 3.0 % alcohol-dependent, 1.0 % marijuana-dependent, 0.6 % stimulant-dependent, and 0.2 % heroin-dependent. Heroin-dependent individuals had 59 % lower odds of obesity relative to their non-dependent counterparts (AOR = 0.41; 95 % CI: 0.28−0.60; p < 0.0001). Lower odds of obesity were also noted for marijuana-dependent (AOR = 0.64; 95 % CI: 0.56−0.73; p < 0.0001), nicotine-dependent (AOR = 0.68; 95 % CI: 0.64−0.72; p < 0.0001) and alcohol-dependent (AOR = 0.77, 95 % CI: 0.69−0.84; p < 0.0001) individuals, but not statistically significant for stimulant-dependent individuals (AOR = 0.84; 95 % CI: 0.68−1.02; p = 0.0825). ConclusionsHeroin, marijuana, nicotine and alcohol dependence were associated with lower odds of obesity than their non-dependence counterparts. Main findings based on 2015–2017 NSDUH are consistent with findings from our prior report based on clinical trials data from National Institute on Drug Abuse Clinical Trials Network, and other epidemiological evidence in the literature. These findings can alert substance abuse treatment professionals to monitor weight change, especially among weight-concerned substance abusers.

Variants of opioid genes and response to treatment of opioid use disorder with buprenorphine-naloxone versus extended-release naltrexone in Caucasians

ABSTRACT Background: Sublingual buprenorphine-naloxone (BUP-NX), an FDA-approved treatment for opioid use disorder (OUD), combines buprenorphine (a partial mu/kappa agonist) with naloxone (a mu/ kappa antagonist). Extended-release injection naltrexone (XR-NTX; a mu receptor antagonist and kappa receptor partial agonist) is also an FDA-approved treatment for OUD. However, while some patients respond well to these medications, many others leave treatment and relapse. Objectives: Determine whether gene variants in the opioid gene system are associated with better or worse treatment response. Methods: In a 24-week, multisite, randomized, comparative effectiveness trial of daily, sublingual self-administration of BUP-NX versus monthly injection of XR-NTX conducted in the National Drug Abuse Clinical Trials Network, DNA was collected and four opioid gene variants were evaluated: (1) mu opioid receptor 118A>G; (2) 68-bp repeat in prodynorphin; (3) prodynorphin SNP rs910080; and (4) kappa opioid receptor SNP rs6473797. In non-Hispanic Caucasians (N = 334), two outcomes measures were assessed: received first dose (yes/no) and received last dose (yes/no). Separate logistic regressions were used to model each outcome measure as a function of treatment (XR-NTX vs BUP-NX), each gene variant, and their interaction. Results: There were no significant main effects of gene variant on receiving first dose or last dose. There were also no significant gene variant by treatment interactions. Conclusions: The outcome of treatment of OUD with medications is likely a complex function of multiple factors, including environmental, psychosocial, and possibly genetic, such that major effects of genetic variants may be unlikely.

Dental Care Utilization of Hospitalized Persons Living with HIV and Substance Use.

People living with HIV (PLWH) who use drugs experience worse health outcomes than their non-using counterparts. Little is known about how often they seek dental care and the factors that influence their utilization. PLWH with substance use disorders who were inpatients at 11 urban hospitals (n = 801) participated in a National Institute on Drug Abuse Clinical Trials Network study to improve engagement in HIV outcomes. Dental care utilization at each time point during the study period (baseline, 6months and/or 12months) was assessed (n = 657). Univariate analysis and logistic regression were used to examine factors associated with dental care utilization. Over half (59.4%) reported not having received any dental care at any timepoint. Participants with less than high school education had lower odds of reporting dental care utilization than those with more than education (aOR = 0.60 [95% CI 0.37-0.99], p = 0.0382). Participants without health insurance also had lower odds of reporting dental care utilization than those with insurance (aOR = 0.50 [95% CI 0.331-0.76], p = 0.0012). Higher food insecurity was associated with having recent dental care utilization (OR = 1.03 [95% CI 1.00, 1.05], p = 0.0359). Additionally, those from Southern states were less likely to report dental care utilization (aOR = 0.55 [95% CI 0.38, 0.79], p = 0.0013). Having health insurance and education are key factors associated with use of dental care for PLWH with substance use disorders. The association between food insecurity and dental care utilization among this population suggests the need for further exploration.

Validation of Addiction Severity Index (ASI) for Assessment of Psychiatric Comorbidity in Multi-Site Randomized Controlled Trials

Objective: This study aimed to assess the validity of the psychiatric problems subscale of the Addiction Severity Index (ASI-psych) to ascertain psychiatric comorbidity among individuals participating in randomized controlled trials (RCTs) of substance use disorder (SUD) treatments.Methods: The ASI-psych score among 1,660 RCT participants of National Institute of Drug Abuse Clinical Trials Network studies was compared against diagnosis of any serious mental disorder based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (SCID) or Mini-International Neuropsychiatric Interview (MINI). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) for detecting any serious mental disorders were estimated by the receiver operating characteristic (ROC) analysis.Results: Based on the overall sample, the AUC score for any serious mental disorder was 0.72 (95% confidence interval [CI], [0.69, 0.75]) with the optimal ASI-psych score of 24.6. There was no statistically significant difference in AUCs based on the SCID and MINI (χ2 = 0.05, p = .82) or by target drugs of RCTs (χ2 =1.33, p = .72).Conclusions: Results support the utility of the ASI in screening for psychiatric comorbidity among patients receiving SUD treatments in RCT settings.

Implementation of emergency department–initiated buprenorphine for opioid use disorder in a rural southern state

AimThe National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN), an entity aimed at bridging researchers and community-based substance abuse treatment providers to develop new treatment approaches, has taken an interest in the dissemination of findings from a randomized clinical trial by D'Onofrio demonstrating that initiating buprenorphine in the emergency department (ED) enhances linkage to treatment [JAMA 2015; 313 (16): 1636–1644]. In the Southern Consortium Node of the CTN, the authors have taken an implementation science approach to expand on the D'Onofrio study by implementing an ED-based buprenorphine initiation program in three diverse South Carolina EDs utilizing a predominantly peer recovery coach model. The aim of this pilot program was to foundationally integrate universal screening, brief interventions and referral to treatment (SBIRT) in hospital EDs to identify patients with at-risk substance use. Through brief interventions, patient navigators assessed readiness to change and motivation for treatment of patients. Patients willing to engage in treatment were referred to appropriate community resources. Patients identified to have opioid use disorder (OUD) and willing to engage in treatment were eligible for ED-initiated buprenorphine and peer recovery coaches assisted in arranging next day follow up with a community treatment program or other local provider for ongoing treatment. MethodHospital partner sites included a large academic medical center, a large private hospital, and a small community hospital. Prior to implementing this quality improvement initiative, the authors completed an ED workflow analysis at each site, developed internal planning committees including identification of a “hospital champion,” facilitated electronic health record modifications, educated more than 200 ED nurses and providers, and identified a network of local community “fast-track” providers able to accept patients for next-day appointments. ResultsWithin 14 months, all three sites were fully operationalized and project staff in 3 ED sites screened 6523 patients for substance misuse with 33.0% screened positive for at-risk substance use. Positive screening results were as follows by substance: 907 alcohol, 100 cocaine, 40 methamphetamine, 7 amphetamines, 96 marijuana, 12 benzodiazepines, 3 Ecstasy/MDMA/Molly, 10 other/unknown substance, 274 heroin, 90 prescription opioids, 32 other/unknown opioid, 254 undetermined polysubstance use without opioids, and 331 polysubstance use with opioids. Of the 727 positive screened patients for non-medical opioid use, 70.0% were determined potentially eligible to receive buprenorphine initiation. Two-hundred thirty-one patients were initiated with one dose of 8 mg sublingual buprenorphine or 8-2 mg sublingual buprenorphine/naloxone; 76.6% of those initiated arrived to next-day appointments for continued medications for opioid use disorder (MOUD); and 59.9% of those patients were retained in treatment at 30 days. Of referred patients, payor at time of ED visit were as follows: 71.1% uninsured, 21.4% state Medicaid, 1.6% Medicare, and 5.9% private health insurance. ConclusionWith adequate resources and institutional support, implementation of evidence-based quality improvement initiatives focused on OUDs are feasible and enhance linkage to evidence-based treatment in a rural Southern state. Lessons learned from this implementation study can be used to guide future CTN studies focused on ED settings. Project supportFinancially supported by South Carolina Department of Health and Human Services with consultation and guidance from Mosaic Group and South Carolina Department of Alcohol and Other Drug Services.

Parallel modeling of pain and depression in prediction of relapse during buprenorphine and naloxone treatment: A finite mixture model

BackgroundRelapse is common in treatment for opioid use disorders (OUDs). Pain and depression often co-occur during OUD treatment, yet little is known about how they influence relapse among patients with a primary diagnosis of prescription opioid use disorder (POUD). Advanced statistical analyses that can simultaneously model these two conditions may lead to targeted clinical interventions. MethodThe objective of this study was to utilize a discrete survival analysis with a growth mixture model to test time to prescription opioid relapse, predicted by parallel growth trajectories of depression and pain, in a clinical sample of patients in buprenorphine/naloxone treatment. The latent class analysis characterized heterogeneity with data collected from the National Institute of Drug Abuse Clinical Trials Network project (CTN-0030). ResultsResults suggested that a 4-class solution was the most parsimonious based on global fit indices and clinical relevance. The 4 classes identified were: 1) low relapse, 2) high depression and moderate pain, 3) high pain, and 4) high relapse. Odds ratios for time-to-first use indicated no statistically significant difference in time to relapse between the high pain and the high depression classes, but all other classes differed significantly. ConclusionThis is the first longitudinal study to characterize the influence of pain, depression, and relapse in patients receiving buprenorphine and naloxone treatment. These results emphasize the need to monitor the influence of pain and depression during stabilization on buprenorphine and naloxone. Future work may identify appropriate interventions that can be introduced to extend time-to-first prescription opioid use among patients.

Suicidal Ideation and Suicide Attempts among Women Seeking Treatment for Substance Use and Trauma Symptoms

Substance use disorders and posttraumatic stress disorder have been associated with suicide. Through secondary analysis of the screening data from the Women and Trauma Study conducted by the National Institute on Drug Abuse Clinical Trials Network, the present study examined rates and correlates of suicidal ideation and suicide attempts among women who sought treatment for substance use and trauma at seven outpatient substance use programs. The sample included women between the ages of 18 and 65 years (M = 39.2; SD = 9.3) and was 44 percent white, 33 percent African American, 8 percent Latina, and 15 percent other races or ethnicities. Logistic regression was used to examine factors associated with a lifetime history of recurrent suicidal ideation and a serious suicide attempt. Findings highlight the need for social workers to address elevated risk levels for suicidal thoughts and behaviors when working with women with histories of substance use and trauma.

Comparing pharmacological treatments for cocaine dependence: Incorporation of methods for enhancing generalizability in meta‐analytic studies

Few head-to-head comparisons of cocaine dependence medications exist, and combining data from different randomized controlled trials (RCTs) is fraught with methodological challenges including limited generalizability of the RCT findings. This study applied a novel meta-analytic approach to data of cocaine dependence medications. Data from 4 placebo-controlled RCTs (Reserpine, Modafinil, Buspirone, and Ondansetron) were obtained from the National Institute of Drug Abuse Clinical Trials Network (n=456). The RCT samples were weighted to resemble treatment-seeking patients (Treatment Episodes Data Set-Admissions) and individuals with cocaine dependence in general population (National Survey on Drug Use and Health). We synthesized the generalized outcomes with pairwise meta-analysis using individual-level data and compared the generalized outcomes across the 4 RCTs with network meta-analysis using study-level data. Weighting the data by the National Survey on Drug Use and Health generalizability weight made the overall population effect on retention significantly larger than the RCT sample effect. However, there was no significant difference between the population effect and the RCT sample effect on abstinence. Weighting changed the ranking of the effectiveness across treatments. Applying generalizability weights to meta-analytic studies is feasible and potentially provides a useful tool in assessing comparative effectiveness of treatments for substance use disorders in target populations.

Cigarette smoking and quit attempts among Latinos in substance use disorder treatment

ABSTRACTBackground: Differences in tobacco use behaviors have been identified between Latinos and non-Latino whites in the general US population. Little is known about cigarette smoking and quitting behaviors of Latinos in treatment for substance use disorders (SUDs), who represent two major tobacco-vulnerable groups. Objectives: To compare, in a national sample of persons enrolled in SUD treatment, demographic, drug use, and smoking and quitting prevalence and behaviors between Latinos and non-Latino whites. Methods: We surveyed 777 SUD treatment clients, sampled from 24 clinics selected at random from the National Institute on Drug Abuse Clinical Trials Network (Latino client n = 141; 40% female). We then conducted univariate and multivariate analyses to identify correlates of smoking behaviors by Latino/non-Latino white ethnicity. Results: Latinos’ smoking prevalence resembled that of non-Latino whites (78.7% vs. 77.4%). In regression analyses, Latino smokers (n = 111) tended to smoke fewer cigarettes per day (CPD) than non-Latino white smokers (n = 492); were more often nondaily smokers and menthol smokers; more often reported a smoking quit attempt in the last year; and tended to report higher numbers of past-year quit attempts. Among Latino smokers, those with less education and those reporting opioids as their primary drug of use reported higher CPD. Conclusions: Latinos in SUD treatment are at equally high risk of being current heavy smokers as compared to non-Latino whites in SUD treatment. At the same time, Latinos in SUD treatment exhibit ethnic-specific smoking and quitting behaviors that should be considered when designing smoking interventions for this group.