Community-Based Cluster-Randomized Trial to Reduce Opioid Overdose Deaths.

BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).

Reductions in World Health Organization risk drinking level are associated with improvements in sleep problems among individuals with alcohol use disorder.

AIMS: Among individuals with alcohol use disorder (AUD), sleep disturbances are pervasive and contribute to the etiology and maintenance of AUD. However, despite increased attention toward the relationship between alcohol use and sleep, limited empirical research has systematically examined whether reductions in drinking during treatment for AUD are associated with improvements in sleep problems. METHODS: We used data from a multisite, randomized, controlled trial that compared 6 months of treatment with gabapentin enacarbil extended-release with placebo for adults with moderate-to-severe AUD (N = 346). The Timeline Follow-back was used to assess WHO risk drinking level reductions and the Pittsburgh Sleep Quality Index was used to assess sleep quality over the prior month at baseline and the end of treatment. RESULTS: Sleep problem scores in the active medication and placebo groups improved equally. Fewer sleep problems were noted among individuals who achieved at least a 1-level reduction (B = -0.99, 95% confidence interval (CI) [-1.77, -0.20], P = .014) or at least a 2-level reduction (B = -0.80, 95% CI [-1.47, -0.14], P = .018) in WHO risk drinking levels at the end of treatment. Reductions in drinking, with abstainers excluded from the analysis, also predicted fewer sleep problems at the end of treatment (1-level: B = -1.01, 95% CI [-1.83, -0.20], P = .015; 2-level: B = -0.90, 95% CI [-1.59, -0.22], P = .010). CONCLUSIONS: Drinking reductions, including those short of abstinence, are associated with improvements in sleep problems during treatment for AUD. Additional assessment of the causal relationships between harm-reduction approaches to AUD and improvements in sleep is warranted.

Stability of Drinking Reductions and Long-term Functioning Among Patients with Alcohol Use Disorder.

BACKGROUND: The World Health Organization (WHO) categorizes alcohol consumption according to grams consumed into low-, medium-, high-, and very-high-risk drinking levels (RDLs). Although abstinence has been considered the ideal outcome of alcohol treatment, reductions in WHO RDLs have been proposed as primary outcomes for alcohol use disorder (AUD) trials. OBJECTIVE: The current study examines the stability of WHO RDL reductions and the association between RDL reductions and long-term functioning for up to 3 years following treatment. DESIGN AND PARTICIPANTS: Secondary data analysis of patients with AUD enrolled in the COMBINE Study and Project MATCH, two multi-site, randomized AUD clinical trials, who were followed for up to 3 years post-treatment (COMBINE: n = 694; MATCH: n = 806). MEASURES: Alcohol use was measured via calendar-based methods. We estimated all models in the total sample and among participants who did not achieve abstinence during treatment. KEY RESULTS: One-level RDL reductions were achieved by 84% of patients at the end of treatment, with 84.9% of those individuals maintaining that reduction at a 3-year follow-up. Two-level RDL reductions were achieved by 68% of patients at the end of treatment, with 77.7% of those individuals maintaining that reduction at a 3-year follow-up. One- and two-level RDL reductions at the end of treatment were associated with significantly better mental health, quality of life (including physical quality of life), and fewer drinking consequences 3 years after treatment (p < 0.05), as compared to no change or increased drinking. CONCLUSION: AUD patients can maintain WHO RDL reductions for up to 3 years after treatment. Patients who had WHO RDL reductions functioned significantly better than those who did not reduce their drinking. These findings are consistent with prior reports suggesting that drinking reductions, short of abstinence, yield meaningful improvements in patient health, well-being, and functioning.

Can Alcohol Use Disorder Recovery Include Some Heavy Drinking? A Replication and Extension up to 9 Years Following Treatment.

BACKGROUND: Recent research indicates some individuals who engage in heavy drinking following treatment for alcohol use disorder fare as well as those who abstain with respect to psychosocial functioning, employment, life satisfaction, and mental health. The current study evaluated whether these findings replicated in an independent sample and examined associations between recovery profiles and functioning up to 6 years later. METHODS: Data were from the 3-year and 7- to 9-year follow-ups of subsamples initially recruited for the COMBINE study (3-year follow-up: n = 694; 30.1% female, 21.0% non-White; 7- to 9-year follow-up: n = 127; 38.9% female, 27.8% non-White). Recovery at 3 years was defined by latent profile analyses including measures of health functioning, quality of life, employment, alcohol consumption, and cannabis and other drug use. Functioning at the 7- to 9-year follow-up was assessed using single items of self-rated general health, hospitalizations, and alcohol consumption. RESULTS: We identified 4 profiles at the 3-year follow-up: (i) low-functioning frequent heavy drinkers (13.9%), (ii) low-functioning infrequent heavy drinkers (15.8%), (iii) high-functioning heavy drinkers (19.4%), and (iv) high-functioning infrequent drinkers (50.9%). At the 7- to 9-year follow-up, the 2 high-functioning profiles had the best self-rated health, and the high-functioning heavy drinking profile had significantly fewer hospitalizations than the low-functioning frequent heavy drinking profile. CONCLUSIONS: Previous findings showing heterogeneity in recovery outcomes were replicated. Most treatment recipients functioned well for years after treatment, and a subset who achieved stable recovery engaged in heavy drinking and reported good health outcomes up to 9 years after treatment. Results question the long-standing emphasis on drinking practices as a primary outcome, as well as abstinence as a recovery criterion in epidemiologic and treatment outcome research and among stakeholder groups and funding/regulatory agencies. Findings support an expanded recovery research agenda that considers drinking patterns, health, life satisfaction, and functioning.

Screening, Brief Intervention, and Referral to Treatment in the Emergency Department: An Examination of Health Care Utilization and Costs.

BACKGROUND: There is increasing interest in deploying screening, brief intervention, and referral to treatment (SBIRT) practices in emergency departments (ED) to intervene with patients at risk for substance use disorders. However, the current literature is inconclusive on whether SBIRT practices are effective in reducing costs and utilization. OBJECTIVE: This study sought to evaluate the health care costs and health care utilization associated with SBIRT services in the ED. RESEARCH DESIGN: This study analyzed downstream health care utilization and costs for patients who were exposed to SBIRT services within an Allegheny County, Pennsylvania, ED through a program titled Safe Landing compared with 3 control groups of ED patients (intervention hospital preintervention, and preintervention and postintervention time period at a comparable, nonintervention hospital). SUBJECTS: The subjects were patients who received ED SBIRT services from January 1 to December 31 in 2012 as part of the Safe Landing program. One control group received ED services at the same hospital during a previous year. Two other control groups were patients who received ED services at another comparable hospital. MEASURES: Measures include total health care costs, 30-day ED visits, 1-year ED visits, inpatient claims, and behavioral health claims. RESULTS: Results found that patients who received SBIRT services experienced a 21% reduction in health care costs and a significant reduction in 1-year ED visits (decrease of 3.3 percentage points). CONCLUSIONS: This study provides further support that SBIRT programs are cost-effective and cost-beneficial approaches to substance use disorders management, important factors as policy advocates continue to disseminate SBIRT practices throughout the health care system.

Alcohol use and the wage returns to education and work experience.

Despite a widely held belief that alcohol use should negatively impact wages, much of the literature on the topic suggests a positive relationship between nonproblematic alcohol use and wages. Studies on the effect of alcohol use on educational attainment have also failed to find a consistent, negative effect of alcohol use on years of education. Thus, the connections between alcohol use, human capital, and wages remain a topic of debate in the literature. In this study, we use the 1997 cohort of the National Longitudinal Survey of Youth to estimate a theoretical model of wage determination that links alcohol use to wages via human capital. We find that nonbinge drinking is associated with lower wage returns to education whereas binge drinking is associated with increased wage returns to both education and work experience. We interpret these counterintuitive results as evidence that alcohol use affects wages through both the allocative and productive efficiency of human capital formation and that these effects operate in offsetting directions. We suggest that alcohol control policies should be more nuanced to target alcohol consumption in the contexts within which it causes harm.

Development and evaluation of two instruments for assessing screening, brief intervention, and referral to treatment (SBIRT) competency.

BACKGROUND: Screening, brief intervention, and referral to treatment (SBIRT) is shown to be effective in identifying, intervening with, and making appropriate referrals for patients with unhealthy alcohol use. SBIRT training consists of knowledge-based and skill-based components and has increased the use of screening and intervention skills in clinical settings. This article reports on the development and evaluation of 2 SBIRT proficiency checklists for use across institutions to assess SBIRT skills in both simulated and clinical encounters. METHODS: A national panel of 16 experts identified 137 discrete SBIRT skills items for the checklists. From this final list, 2 proficiency checklists were derived: the SBIRT Proficiency Checklist (SPC), composed of 22 questions for videotaped interviews, and the Clinical SBIRT Proficiency Checklist (CSPC), composed of 13 questions for direct clinical observation. An evaluation was conducted to test the reliability of the SPC and to assess the utility of the CSPC. RESULTS: Two checklists for assessing SBIRT proficiency were developed by a collaborative workgroup. Fleiss' kappa analyses indicated moderate agreement. In addition, faculty recorded satisfaction with the CSPC for assessing residents on their SBIRT performance during clinical encounters. CONCLUSIONS: The SPC and the CSPC are practical tools for assessing competence with SBIRT and are easily integrated as standard instruments in a wide range of training settings. Future advancements to the checklists and their evaluation include modification of the SPC rating scale to be consistent with the CSPC, developing a training program for using the checklists, and further testing to improve interrater reliability.

The Relationship Between End-of-Treatment Alcohol Use and Subsequent Healthcare Costs: Do Heavy Drinking Days Predict Higher Healthcare Costs?

BACKGROUND: A challenge for evaluating alcohol treatment efficacy is determining what constitutes a "good" outcome or meaningful improvement. Abstinence at the end of treatment is an unambiguously good outcome; however, a focus on abstinence ignores the potential benefits of patients reducing their drinking to less problematic levels. Patients may be drinking at low-risk levels at the end of treatment but may be high-functioning and impose few social costs. In this study, we estimate the relationship between drinking at the end of COMBINE treatment and subsequent healthcare costs with an emphasis on heavy and nonheavy drinking levels. METHODS: Indicators of heavy drinking days (HDDs; 5+ drinks for men, 4+ for women) and nonheavy drinking days (non-HDDs) during the last 30 days of COMBINE treatment were constructed for 748 patients enrolled in the COMBINE Economic Study. Generalized linear models were used to model total costs following COMBINE treatment as a function of drinking indicators. Different model specifications analyzed alternative counts of HDDs (e.g., 1 HDD and 2 to 30 HDDs), and groups having Both non-HDDs and HDDs. RESULTS: Patients with HDDs had 66.4% (p < 0.01) higher healthcare costs than those who were abstinent. Having more than 2 HDDs was associated with the highest costs (75.9%, p < 0.01). Patients with non-HDDs had costs that were not significantly different than abstainers, even if they also had HDDs. However, those with HDDs only had costs 91.7% higher than abstainers (p < 0.01). CONCLUSIONS: Having HDDs at the end of treatment is associated with higher costs. Patients who had Only HDDs at the end of treatment had worse subsequent outcomes than those who had Both non-HDDs and HDDs. These findings offer new context for evaluating treatment outcomes and provide new information on the association of drinking with consequences.

The Impact of a Mandated Trauma Center Alcohol Intervention on Readmission and Cost per Readmission in Arizona.

BACKGROUND: Persons appearing in trauma centers have a higher prevalence of unhealthy alcohol use than the general population. Screening and brief intervention (SBI) is designed to moderate drinking levels and avoid costly future readmissions, but few studies have examined the impact of SBI on hospital readmissions and health care costs in a trauma population. RESEARCH DESIGN: This study uses comparative interrupted time-series and the Arizona State Inpatient Database to estimate the effect of the American College of Surgeons Committee on Trauma SBI mandate on the probability of readmission and cost per readmission in Arizona trauma centers. We compare individuals with and without an alcohol diagnosis code before and after the mandate was implemented. RESULTS: The mandate resulted in a 2.2 percentage point reduction (44%) in the probability of readmission. Total health care and readmission costs were not affected by the mandate. CONCLUSIONS: The estimates are consistent with a differential effect of SBI: SBI reduces readmissions among those who present with a less serious alcohol-related problem. Persons with more serious alcohol problems are less likely to respond to SBI. These higher risk individuals likely have a higher cost, which may explain the lack of change in readmission costs. Our study is a macrolevel intent-to-treat analysis of SBI's impact that corroborates the potential of SBI implied by efficacy studies in trauma centers and other settings. This study provides a framework for future research involving more states and health systems and evaluating other SBI policies.

The mental health consequences of nonmedical prescription drug use among adolescents.

BACKGROUND: Nonmedical prescription drug use is estimated to be the second most abused category of drugs after marijuana among adolescents. Prescription drugs can be highly addictive and prolonged use can produce neurological changes and physiological dependence and could result in adverse mental health outcomes. This topic is largely unexplored, as current knowledge of possible mechanisms of the linkage between adverse mental health consequences and prescription drug misuse is limited. AIM OF THE STUDY: This study explores the relationship between nonmedical use of prescription drugs and depression outcomes among adolescents. Given their complex and confounded relationship, our purpose is to better understand the extent to which nonmedical use of prescription drugs is an antecedent of depressive episodes. METHODS: Using data from the 2008-2012 National Survey on Drug Use and Health, the study employs a propensity score matching methodology to ascertain whether nonmedical use of prescription drugs is linked to major depressive episodes among adolescents. RESULTS: The results document a positive relationship between nonmedical prescription drug use and major depressive episodes among adolescents. Specifically, the results indicate that adolescents who used prescription drugs non-medically are 33% to 35% more likely to experience major depressive episodes compared to their non-abusing counterparts. IMPLICATIONS FOR HEALTH POLICY: This provides additional evidence about the potential public health consequences of misuse of prescription drugs on adverse mental health outcomes. Given the significant increased risk of major depressive episode among adolescents who use prescription drugs nonmedically, it seems that the prevention of nonmedical prescription drug use warrants the utilization of both educational and public health resources. IMPLICATIONS FOR FUTURE RESEARCH: An important area for future research is to understand how any policy initiatives in this area must strike a balance between the need to minimize the misuse of prescription drugs and the need to ensure access for their legitimate health care use.

Use of fentanyl test strips by people who inject drugs: Baseline findings from the South Atlantic Fentanyl Test Strip Study (SAFTSS).

BACKGROUND: Research published during the early fentanyl period exposed a growing concern of unwitting fentanyl exposure and a general willingness to use fentanyl test strips (FTS). A paucity of FTS studies over the last several years has restricted our ability to understand FTS use in the late fentanyl era. The South Atlantic FTS Study (SAFTSS) was established to investigate contemporaneous changes in FTS use and drug use behavior among a rural cohort of PWID. METHODS: Between June 2021 and March 2022, a total of 541 PWID completed an in-person survey. Baseline survey questions included demographics, socioeconomic characteristics, and drugs used. FTS questions covered lifetime use, past 6-months, and past 30-day use and included reasons for using FTS, levels of access, and confidence testing illicit opioids and stimulants. Multivariable analyses examined significant baseline correlates of lifetime and 30-day FTS use. RESULTS: Overall, more than half (58%; N=315) used FTS in their lifetime. Among lifetime FTS users, almost half (47%) used FTS in the past 6 months and 30% in the past 30 days, with an average of 13 months from last FTS use and the baseline survey. The most common reason for not using FTS was "not having them with me when I use drugs." Less frequent reasons were "I already know it's fentanyl" followed by "FTS take too much time to use." Among past 30-day FTS users, 74% used FTS on heroin, 55% on methamphetamine, and 33% on fentanyl. Consumer confidence using FTS was higher with illicit opioids (66%) but lower for methamphetamine (43%). In both the lifetime and past 30-day models, PWID with FTS use were more likely than non-users to have witnessed an overdose in the past six months (lifetime aOR = 2.85, p<.001; 30-day aOR=2.57, p<.01). Virtually no differences in drug use behaviors were found when comparing past 30-days FTS use to no FTS use. Women (aOR=1.68, p<.05) and non-white PWID (aOR=2.43, p<.05) were more likely than men and white PWID to have used FTS. CONCLUSIONS: Declines in FTS use are consistent with what syringe services programs have been signaling for years. Needs assessments to gauge interest in FTS before scaling up can help ensure funding better spent on naloxone and syringes is not allocated to idle FTS. Increased FTS among women and racial minorities presents opportunities for tailored interventions. Recognizing trauma associated with witnessing overdoses as a growing component of the opioid epidemic is a critical first step toward addressing the full spectrum of drug-related harm.

Healthcare expenditures for people with substance use disorders in drug courts compared to their peers in traditional courts.

Individuals within the criminal justice system are at greater risk of substance use-related morbidity and mortality and have substantial healthcare needs. In this quasi-experimental study, we assessed utilization patterns of Massachusetts Medicaid Program (MassHealth) services and associated expenditures among drug court probationers compared to a propensity score-matched sample of traditional court probationers. Risk of reoffending, employment status, age, and living arrangement data were used to calculate propensity scores and match probationers between the two court types, producing a final sample of 271 in each court (N=542). Utilization of services and associated expenditures were analyzed using a two-part model to address the skewed distribution of the data and to control for residual differences after matching from the perspective of the payer (i.e., MassHealth). The largest categories of MassHealth spending were prescription pharmaceuticals, hospital inpatient visits, and physician visits. In the unadjusted analysis, drug court probationers exhibited greater MassHealth services utilization and expenditures than traditional court probationers. However, drug courts enrolled more females, more people at higher risk of reoffending, and more people with opioid use disorders. After controlling for differences between the two court types, the difference in MassHealth services utilization and associated expenditures did not reach statistical significance. Drug court probationers were more likely to engage with healthcare services but did not incur significantly greater expenditures than traditional court probationers after controlling for differences between the samples.

Establishing a Protocol for Determining the Costs of an Integrated Set of Evidence-based Practices Aimed at Reducing Opioid Overdose Deaths.

OBJECTIVES: In the midst of the opioid overdose crisis, local jurisdictions face a choice of public health interventions. A significant barrier when considering evidence-based practices (EBPs) is the lack of information regarding their implementation cost. This protocol paper provides the methodological foundation for the economic cost evaluations of community-wide strategies on the scale of a national study. It can serve as a resource for other communities, local policymakers, and stakeholders as they consider implementing possible public health strategies in their unique settings. METHODS: We present a protocol that details (1) the process of identifying, reviewing, and analyzing individual strategies for study-funded and non-study-funded costs; (2) prospective costing tool designation, and; (3) data collection. To do this, we set up working groups with community stakeholders, reviewed financial invoices, and surveyed individuals with detailed knowledge of their community implementation. DISCUSSION: There were 3 main challenges/limitations. The first was the lack of a standard structure for documenting nonfunded costs associated with each strategy. The second was the need for timely implementation of cost data. The third was generalizability because our study designed its strategies for selected communities due to their high opioid overdose mortality rates. Future steps include more tailored questions to ask during the categorization/filter process and establishing realistic expectations for organizations regarding documenting. CONCLUSIONS: Data collected will provide a critical methodological foundation for costing large community-based EBP strategies and provide clarity for stakeholders on the cost of implementing EBP strategies to reduce opioid overdose deaths.

Project Lifeline-II: Feasibility of Implementing Screening, Brief Intervention, and Referral to Treatment (SBIRT) in Allegheny County, Pennsylvania.

OBJECTIVES: US community pharmacies are a unique and underused health service setting for identifying and potentially intervening with patients at risk of opioid overdose or opioid use disorder with evidence-based practices such as screening, brief intervention, and referral to treatment (SBIRT). The aim of our study was to assess the feasibility of implementing SBIRT in community pharmacies in an urban county in terms of engagement, reach, and equity across the cascade of pharmacy screening and care. METHODS: Patients aged 18 years or older receiving a schedule II or III opioid prescription at 1 of 17 participating community pharmacies in Allegheny County, Pennsylvania, were invited to engage in SBIRT as part of Project Lifeline-II from June 2020 through January 2023. Participants completed a prescreen and/or a full screen. We calculated the percentage of patients who participated across the cascade of pharmacy screening and care, overall and by sex (male and female) and race (Black and White). RESULTS: During the study period, 1952 unique adults (79.6%) were screened at least once (52.1% female; 58.0% White, 30.7% Black). Patients who identified as male (vs female) and Black (vs White) were more likely to have a positive prescreen (14.7% male vs 9.8% female; 16.4% Black vs 9.5% White), receive and complete a full screen (82.7% male vs 80.0% female; 83.6% Black vs 78.4% White), and score positively on the full screen (26.6% male vs 20.4% female; 26.8% Black vs 21.9% White). CONCLUSION: Although additional research is needed to characterize the full effect of Project Lifeline-II on patient outcomes, our findings help reinforce the benefits of multipronged public health initiatives that include community pharmacists to address the substance use disorder crisis in the United States.

Reductions in World Health Organization Risk Drinking Level Are Associated With Reductions in Alcohol Use Disorder Diagnosis and Criteria: Evidence From an Alcohol Pharmacotherapy Trial.

OBJECTIVES: This study aimed to evaluate the validity of World Health Organization (WHO) risk drinking level reductions as meaningful endpoints for clinical practice and research. This study examined whether such reductions were associated with a lower likelihood of a current alcohol use disorder (AUD) diagnosis and fewer AUD criteria. METHODS: We conducted a secondary data analysis to address these objectives using data from a multisite randomized controlled trial of gabapentin enacarbil extended release in treating moderate to severe AUD among adults (N = 346). Participants received gabapentin enacarbil extended release or placebo for 6 months. The timeline follow-back was used to assess WHO risk drinking level reductions, and the Mini-International Neuropsychiatric Interview was used to assess Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) AUD diagnosis and criteria at baseline (past year) and end of treatment (past month). RESULTS: Most participants (80.1%) achieved at least a 1-level reduction in the WHO risk drinking levels from baseline to end of treatment, and nearly half of participants (49.8%) achieved at least a 2-level reduction. At least a 1-level reduction or at least a 2-level reduction in WHO risk drinking level predicted lower odds of an active AUD diagnosis (1-level: odds ratio, 0.74 [95% confidence interval (CI), 0.66-0.84]; 2-level: odds ratio, 0.71 [95% CI, 0.64-0.79]) and fewer AUD criteria (1-level: B , -1.66 [95% CI, -2.35 to -0.98]; 2-level: B , -1.76 [95% CI, -2.31 to -1.21]) at end of treatment. CONCLUSIONS: World Health Organization risk drinking level reductions correlate with Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) AUD diagnosis and criteria, providing further evidence for their use as endpoints in alcohol intervention trials, which has potential implications for broadening the base of AUD treatment.

Reductions in WHO risk drinking levels correlate with alcohol craving among individuals with alcohol use disorder.

BACKGROUND: Abstinence has historically been considered the preferred goal of alcohol use disorder (AUD) treatment. However, most individuals with AUD do not want to abstain and many are able to reduce their drinking successfully. Craving is often a target of pharmacological and behavioral interventions for AUD, and reductions in craving may signal recovery. Whether reductions in drinking during AUD treatment are associated with reductions in craving has not been well examined. METHODS: We conducted secondary analyses of data from three AUD clinical trials (N's= 1327, 346, and 200). Drinking reductions from baseline to the end of treatment were measured as changes in World Health Organization (WHO) risk drinking levels; alcohol craving was measured using validated self-report measures. Regression analyses tested whether drinking reductions were associated with end-of-treatment craving reductions; moderation analyses tested whether associations between drinking reduction and end-of-treatment craving differed across AUD severity. RESULTS: Reductions of at least 1 or at least 2 WHO risk drinking levels were associated with lower craving (all p's < 0.05). Results were substantively similar after removing abstainers at the end-of-treatment. Associations between drinking reductions and craving were generally not moderated by AUD severity. CONCLUSIONS: Individuals with WHO risk drinking level reductions reported significantly lower craving, as compared to those who did not achieve meaningful reductions in drinking. The results demonstrate the utility of WHO risk drinking levels as AUD clinical trial endpoints and provide evidence that drinking reductions mitigate craving.

Cost of start-up activities to implement a community-level opioid overdose reduction intervention in the HEALing Communities Study.

BACKGROUND: Communities That HEAL (CTH) is a novel, data-driven community-engaged intervention designed to reduce opioid overdose deaths by increasing community engagement, adoption of an integrated set of evidence-based practices, and delivering a communications campaign across healthcare, behavioral-health, criminal-legal, and other community-based settings. The implementation of such a complex initiative requires up-front investments of time and other expenditures (i.e., start-up costs). Despite the importance of these start-up costs in investment decisions to stakeholders, they are typically excluded from cost-effectiveness analyses. The objective of this study is to report a detailed analysis of CTH start-up costs pre-intervention implementation and to describe the relevance of these data for stakeholders to determine implementation feasibility. METHODS: This study is guided by the community perspective, reflecting the investments that a real-world community would need to incur to implement the CTH intervention. We adopted an activity-based costing approach, in which resources related to hiring, training, purchasing, and community dashboard creation were identified through macro- and micro-costing techniques from 34 communities with high rates of fatal opioid overdoses, across four states-Kentucky, Massachusetts, New York, and Ohio. Resources were identified and assigned a unit cost using administrative and semi-structured-interview data. All cost estimates were reported in 2019 dollars. RESULTS: State-level average and median start-up cost (representing 8-10 communities per state) were $268,657 and $175,683, respectively. Hiring and training represented 40%, equipment and infrastructure costs represented 24%, and dashboard creation represented 36% of the total average start-up cost. Comparatively, hiring and training represented 49%, purchasing costs represented 18%, and dashboard creation represented 34% of the total median start-up cost. CONCLUSION: We identified three distinct CTH hiring models that affected start-up costs: hospital-academic (Massachusetts), university-academic (Kentucky and Ohio), and community-leveraged (New York). Hiring, training, and purchasing start-up costs were lowest in New York due to existing local infrastructure. Community-based implementation similar to the New York model may have lower start-up costs due to leveraging of existing infrastructure, relationships, and support from local health departments.

Effect of the Communities that HEAL intervention on receipt of behavioral therapies for opioid use disorder: A cluster randomized wait-list controlled trial.

BACKGROUND: The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping to End Addiction Long-Term® (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). METHODS: Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. RESULTS: No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. CONCLUSIONS: Several factors should be considered when interpreting results-no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. TRIAL REGISTRATION: Clinical Trials.gov http://www. CLINICALTRIALS: gov: Identifier: NCT04111939.

Communities That HEAL Intervention and Mortality Including Polysubstance Overdose Deaths: A Randomized Clinical Trial.

Importance: The HEALing Communities Study (HCS) evaluated the effectiveness of the Communities That HEAL (CTH) intervention in preventing fatal overdoses amidst the US opioid epidemic. Objective: To evaluate the impact of the CTH intervention on total drug overdose deaths and overdose deaths involving combinations of opioids with psychostimulants or benzodiazepines. Design, Setting, and Participants: This randomized clinical trial was a parallel-arm, multisite, community-randomized, open, and waitlisted controlled comparison trial of communities in 4 US states between 2020 and 2023. Eligible communities were those reporting high opioid overdose fatality rates in Kentucky, Massachusetts, New York, and Ohio. Covariate constrained randomization stratified by state allocated communities to the intervention or control group. Trial groups were balanced by urban or rural classification, 2016-2017 fatal opioid overdose rate, and community population. Data analysis was completed by December 2023. Intervention: Increased overdose education and naloxone distribution, treatment with medications for opioid use disorder, safer opioid prescribing practices, and communication campaigns to mitigate stigma and drive demand for evidence-based interventions. Main Outcomes and Measures: The primary outcome was the number of drug overdose deaths among adults (aged 18 years or older), with secondary outcomes of overdose deaths involving specific opioid-involved drug combinations from death certificates. Rates of overdose deaths per 100 000 adult community residents in intervention and control communities from July 2021 to June 2022 were compared with analyses performed in 2023. Results: In 67 participating communities (34 in the intervention group, 33 in the control group) and including 8 211 506 participants (4 251 903 female [51.8%]; 1 273 394 Black [15.5%], 603 983 Hispanic [7.4%], 5 979 602 White [72.8%], 354 527 other [4.3%]), the average rate of overdose deaths involving all substances was 57.6 per 100 000 population in the intervention group and 61.2 per 100 000 population in the control group. This was not a statistically significant difference (adjusted rate ratio [aRR], 0.92; 95% CI, 0.78-1.07; P = .26). There was a statistically significant 37% reduction (aRR, 0.63; 95% CI, 0.44-0.91; P = .02) in death rates involving an opioid and psychostimulants (other than cocaine), and nonsignificant reductions in overdose deaths for an opioid with cocaine (6%) and an opioid with benzodiazepine (1%). Conclusion and Relevance: In this clinical trial of the CTH intervention, death rates involving an opioid and noncocaine psychostimulant were reduced; total deaths did not differ statistically. Community-focused data-driven interventions that scale up evidence-based practices with communications campaigns may effectively reduce some opioid-involved polysubstance overdose deaths. Trial Registration: ClinicalTrials.gov Identifier: NCT04111939.

Associations between opioid overdose deaths and drugs confiscated by law enforcement and submitted to crime laboratories for analysis, United States, 2014-2019: an observational study.

Background: The overdose epidemic in the United States (US) continues to generate unprecedented levels of mortality. There is urgent need for a national data system capable of yielding high-quality, timely, and actionable information on existing and emerging drugs. Public health researchers have started using law enforcement forensic laboratory data to obtain surveillance information on illicit drugs. This study is the first to use drug reports from the entire US to examine correlations between a changing drug supply and increasing opioid-involved overdose deaths (OOD) on a national scale. Methods: This study is observational and investigates associations between law enforcement drug reports and OOD for the US from 2014 to 2019. OOD data are from the Centers for Disease Control and Prevention's National Vital Statistics System restricted-use multiple cause of death files. The US Drug Enforcement Administration's National Forensic Laboratory Information System (NFLIS) contains forensic laboratory-tested drug exhibit information for the entire US (NFLIS-Drug). Counts of forensic laboratory reports and OOD were aggregated for each state by month, quarter, and year. A difference-in-differences framework was used to estimate contemporaneous and lagged associations. Findings: Between 2014 and 2019 in the US, 249,522 OOD were reported, with the annual number nearly doubling from 28,723 to 50,179. OOD involving illicitly manufactured fentanyls (IMF) also increased substantially during this period, from 19.4% to 72.9%. In addition, 3,817,438 forensic laboratory reports in the US that were reported to NFLIS-Drug contained an opioid, stimulant, or benzodiazepine. Reports of fentanyl and fentanyl-related compounds (FFRC) had the strongest association with OOD. Each additional FFRC exhibit was associated with a 2.97% (95% CI: 1.7%, 4.1%) increase in OOD per 100,000 persons per quarter. Interpretation: Adding to the emerging consensus, protracted growth in IMF supply was more strongly associated with OOD than all other illicit drugs reported to NFLIS-Drug over the study time period. Findings demonstrate NFLIS-Drug data usefulness for research that require proxy indicators for the illicit drugs supply. A concerted effort between public health and public safety to make NFLIS-Drug more timely could strengthen its utility as a national, public health, drug surveillance system. Funding: Sangeetha Arctic Slope Mission Services, LLC, ASMS Contract No. ASM5-00017.