Evaluating population-level interventions to reduce inappropriate antibiotic use in healthcare and community settings: A systematic review protocol.

BACKGROUND: Inappropriate antibiotic use contributes significantly to the global challenge of antimicrobial resistance. While government-initiated population-level interventions are fundamental in addressing this issue, their full potential remains to be explored. This systematic review aims to assess the effectiveness of such interventions in reducing inappropriate antibiotic use among antibiotic providers and users in healthcare and community settings. METHODS: We will conduct a systematic literature search across multiple databases and grey literature sources. We will include studies which evaluate the effectiveness of population-level interventions to reduce inappropriate antibiotic use in healthcare and community settings in both high-income and low- and middle-income countries. This includes government-initiated measures targeting antibiotic use through education, restriction, incentivization, coercion, training, persuasion, context modification, behavior modeling, or barrier reduction. Two reviewers will independently perform screening to select eligible studies, followed by data extraction. The outcomes of interest are various measures of antibiotic prescription and consumption, such as Defined Daily Dose (DDD) or number of prescriptions per year. We anticipate including a broad range of study designs and outcome measures. Therefore, we will narratively synthesize results using the categories of the population-level policy interventions of the Behavior Change Wheel Framework. We will organize outcome data by economic contexts, target populations, and implementation settings. DISCUSSION: This review will strengthen the evidence base for the use of population-level interventions to address inappropriate antibiotic use. Drawing lessons from global experiences, the findings will provide valuable guidance to health policymakers, public health authorities, and researchers on tailoring interventions to specific economic contexts, populations, and settings, thereby enhancing their capacity to drive substantial improvement in appropriate antibiotic use.

Uso de drogas y automedicación en estudiantes de escuelas secundarias / Drug use and self-medication in secondary school students

Introducción: La adolescencia es la etapa clave en la adquisición de hábitos y conductas adictivas que perduran toda la vida. Existe un modelo de consumo juvenil de drogas, legales e ilegales, como forma de relación social, uso recreativo y realización personal. El policonsumo no debe ser visto como un rito de transición, sino como un problema de salud pública. Objetivos: Se estudió la prevalencia de consumo de sustancias adictivas y de medicamentos en 520 alumnos, entre 15 y 18 años, de Escuelas Públicas secundarias de la ciudad de Bahía Blanca. Asimismo, caracteriza el marco familiar, hábitos y costumbres de los estudiantes. Grupos estudiados: El 55% de los alumnos encuestados pertenece al sexo femenino y un 36% tiene doble escolaridad. Resultados: Los resultados indican que el 24% de los alumnos manifiesta fumar y un 85% tomar alcohol, de los cuales el 62% llegó a la borrachera. El 25% consume drogas, 96% corresponde a marihuana, 8% cocaína y 7% éxtasis. El 76% declara automedicarse y un 27% considera riesgosa esta práctica. El 84% convive con ambos padres y un 51% no posee materias desaprobadas. Un 35% de los jóvenes no realiza deporte, el 46% estudia otro idioma y un 39% tiene como hábito la lectura. El 25% de los alumnos que reconocen tener actividad sexual no utilizaron ningún método de protección. Conclusiones: Los resultados de la encuesta exponen la magnitud del problema y sumado a la baja edad de los estudiantes, derivan en múltiples consecuencias adversas. Este panorama constituye un desafío para el médico que, junto con la familia, docentes y especialistas, pueden actuar en aspectos preventivos, diagnósticos y terapéuticos.

Introduction: Adolescence is the key stage in the acquisition of habits and addictive behaviors that last a lifetime. There is a pattern of youth drug use, both legal and illegal, as a form of social interaction, recreational use and personal fulfilment. Polydrug use should not be seen as a rite of passage, but as a public health problem. Objetive: This paper studies the prevalence of substance and drug use in 520 students, aged 15-18, from public secondary schools in the city of Bahía Blanca. It also characterizes the family background, habits and customs of the students. Gropus: 55% of the students surveyed were female and 36% of them had double schooling. Results: The results indicate that 24% of the students report smoking and 85% drinking alcohol, of which 62% became drunk. 25% use drugs, 96% marijuana, 8% cocaine and 7% ecstasy. 76% declare that they self-medicate and 27% consider this practice risky. 84% live with both parents and 51% do not have failed subjects in the report card. 35% of those surveyed do not practice sport, 46% study another language and 39% have reading as a habit. 25% of students who admit to sexual activity did not use any method of protection. Conclusions: The results of the survey expose the magnitude of the pro- blem and, coupled with the low age of the students, lead to multiple adverse consequences. This panorama constitutes a challenge for the doctor who, together with the family, teachers and specialists, can act in preventive, diagnostic and therapeutic aspects.

Prevalence of suicide attempt and associations with deliberate self-harm, mental health problems, drug misuse and traumatic experiences - a cross sectional survey of the Norwegian population.

BACKGROUND: Monitoring self-reported suicide attempts (SA) with nationally representative surveys is important to initiate suicide prevention strategies. The aim of the study was to assess the prevalence of SA and compare deliberate self-harm, (DSH), mental health, drug misuse and traumas between SA and non-suicide attempters (NSA). METHODS: In this cross-sectional survey of a representative sample (N=1757) of the Norwegian population, we compared people with self-reported SA (n=54) to NSA (n=1703) regarding sociodemographic data, mental health problems, drug misuse and exposure to trauma. RESULTS: The prevalence of SA was 3.1 %. There was a higher proportion of welfare recipients and more deliberate self-harm, mental health problems, drug misuse and traumas in the SA group compared to NSA. CONCLUSION: This national study confirms the association between suicide attempt and deliberate self-harm, mental health problems, drug misuse and traumas.

DRUG MISUSE AND SELF-MEDICATION AMONG PHARMACY STUDENTS IN JORDAN.

OBJECTIVE: Aim: To estimate risks and prevalence of self-medication and potential abuse risk among pharmacy students in Jordanian Universities. PATIENTS AND METHODS: Materials and Methods: A cross-sectional study design was conducted with 450 students, selected using multistage sampling methods, from seven different universities. Data was collected by self-administrated questionnaires covering demographic and academic information, health-related information, use of self-medication, and pattern of self-medication among pharmacy students. RESULTS: Results: Out of 394 students who answer the questions, 76.9% reported that they had usually treated themselves in case of simple cases without physician or pharmacist consultation. Most commonly used drugs among the surveyed students were Paracetamol 60%, multivitamins supplement 74.25%, and herbal products 37.2%, combination of NSAIDs and Paracetamol 20.6%, and laxatives 19.4%. Cold and flu 25.5%, headache 22.3%, abdominal pain 7.9%, gastric pain 7.9%, cold and flu, headache, abdominal pain, and gastric pain 14.9% were the main conditions which contribute to self-medication practice. It was also found that Pharmacy students were over-confident with the type of cases they could treat without referral to a specialist physician, despite knowing that some of the symptoms may be due to serious health problems. Misuse of analgesics and laxatives was clear, and there was a weakness in knowledge of the indications for the use of the most common drug. CONCLUSION: Conclusions: The prevalence of self-medication among pharmacy students in Jordan is high, and medical teaching institutions need to educate students about the proper use of medicines. Strict legislation and more education on self-medication are necessary for effective use of medicines.

Neuroimaging in Adolescents: Post-Traumatic Stress Disorder and Risk for Substance Use Disorders.

Trauma in childhood and adolescence has long-term negative consequences in brain development and behavior and increases the risk for psychiatric disorders. Among them, post-traumatic stress disorder (PTSD) during adolescence illustrates the connection between trauma and substance misuse, as adolescents may utilize substances to cope with PTSD. Drug misuse may in turn lead to neuroadaptations in learning processes that facilitate the consolidation of traumatic memories that perpetuate PTSD. This reflects, apart from common genetic and epigenetic modifications, overlapping neurocircuitry engagement triggered by stress and drug misuse that includes structural and functional changes in limbic brain regions and the salience, default-mode, and frontoparietal networks. Effective strategies to prevent PTSD are needed to limit the negative consequences associated with the later development of a substance use disorder (SUD). In this review, we will examine the link between PTSD and SUDs, along with the resulting effects on memory, focusing on the connection between the development of an SUD in individuals who struggled with PTSD in adolescence. Neuroimaging has emerged as a powerful tool to provide insight into the brain mechanisms underlying the connection of PTSD in adolescence and the development of SUDs.

Real or fake? Sourcing and marketing of non-prescribed benzodiazepines amongst two samples of people who regularly use illicit drugs in Australia.

INTRODUCTION: There is concern around non-prescribed benzodiazepine use, particularly with increasing detections of counterfeit products containing high-risk novel compounds. The aims of this study were to investigate how and which non-prescribed benzodiazepines are being sourced; forms, appearance and packaging; and awareness of risks associated with non-prescribed benzodiazepines. METHODS: Data were collected from a sample of Australians who inject drugs or use ecstasy and/or other illicit stimulants on a monthly or more frequent basis, and who reported past 6-month use of non-prescribed benzodiazepines (n = 235 and n = 250, respectively). Data were collected on source, diversion from a known/trusted prescription, product name and aesthetic characteristics for the last non-prescribed benzodiazepine obtained. RESULTS: Amongst participants who injected drugs, 71% reported that their last non-prescribed benzodiazepines were diverted from a known/trusted prescription, compared to 59% of participants who used ecstasy/other stimulants. Sourcing via cryptomarkets was rare. Across both samples, the majority reported last obtaining substances sold/marketed as diazepam or alprazolam. Participants sourcing via non-diverted means were twice as likely to obtain alprazolam. Known sourcing of novel compounds was rare. Amongst participants who used ecstasy/other stimulants, 36% reported confidence in the content/dose of non-prescribed benzodiazepines even when the source is unknown. DISCUSSION AND CONCLUSIONS: Most participants obtained substances sold as classic/registered benzodiazepines, mostly via diverted prescriptions, with a substantial minority potentially unaware of counterfeits circulating. While diverted use undeniably presents risks, tightening of prescriptions in Australia could inadvertently lead to greater supply of novel benzodiazepines as seen internationally, reinforcing prioritisation of demand and harm reduction strategies.

World beliefs, character strengths, and hope for the future.

Research in recent years has revealed the rate of premature and avoidable deaths from suicide and drug/|alcohol misuse is rising in the United States. These are sometimes referred to as deaths of despair based on evidence that they are concentrated in relatively poor communities with less access to social resources and low labor force participation. The pattern was first noted in middle-aged White men but seems to be gradually spreading to other ethnic groups. As a first step in establishing a psychological response to this public health issue, the present article summarizes two studies that compared psychological variables to demographics as predictors of hopefulness. A number of intriguing findings emerged. Despite concerns about American despair and conflict, U.S. residents proved the most hopeful among residents of eight countries. Low-income Americans are particularly hopeful except for low-income Whites. Positive character traits and primal beliefs about the world generally proved to be better predictors of hope than ethnicity, financial status, or their interaction. A number of relationships were found between psychological variables and community demographics. The findings as a group suggest hopefulness is driven more by psychological variables than by life circumstances. It is suggested that psychologists could play an important role in the study of this topic by implementing programs intended to enhance hopefulness in impoverished populations, and by encouraging an intentional communal focus on the importance of enhancing well-being.

Reaching out to patients with alcohol and drug misuse problems.

Jeff Fernandez, Lead Alcohol and Drug Nurse, Alcohol and Drug Liaison Team, Royal Free Foundation Trust, London (jfernandez@nhs.net). The team was the Gold Award winner in the Gastrointestinal Nurse of the Year category in the BJN Awards 2023.

Risk characteristics of alcohol and/or drug misuse in repeat emergency department attendees for seizures: a case-control study.

BACKGROUND: There is a bi-directional relationship between seizures and substance misuse, i.e., alcohol and recreational drugs. Seizures and substance misuse are recognised separately to influence increased emergency department (ED) admissions and early death. There is however no understanding of the cumulative influence of these matters on repeat ED attenders for seizures esp. as a third are likely to re-attend within the year. This case-control study compares the characteristics of people with substance misuse to those without substance misuse presenting recurrently with seizures to the ED. METHODS: From a single ED serving a rural population in the Southwest of England, data of all people presenting more than once with a seizure over a 4-year period were examined. The diagnosis of alcohol or drug misuse, deaths, demographic characteristics, and service use were captured. RESULTS: Of 450 repeat attenders, 95 had a recorded history of alcohol and/or drug problems. Those with substance misuse had double the mortality when adjusted for age and gender compared to those without. They were also more likely to be male, younger in age, have mental health issues, live in socially deprived neighborhoods, not take anti-seizure medications and not have had a specialist review in epilepsy services in the previous year. Nearly a quarter of those with addiction issues died in the 4-year period. DISCUSSION: Service provision for this vulnerable group may need to be modelled along different lines to traditional approaches, such as an assertive outreach community-based service as provided for chronic psychiatric and addiction management.

Detection of emerging patterns of drug misuse in sports via wastewater monitoring: A mini-review and potential strategies.

Biological testing is a key component of the current anti-doping programme implemented by the authorities to detect doping in sports. Strategies such as longitudinal individualised data analysis and sport-specific analysis have been developed to increase the comprehensiveness of the testing. However, the trends of drug misuse in sports might not be effectively captured through today's testing plan. Wastewater testing, assembling individual-level data of a designated group to produce population-level results in one single aggregated sample, can be employed to as a complementary strategy offering added value for doping control. This paper presents an updated summary of the status of anti-doping testing and analytical methodologies for wastewater. The available literature on wastewater-based analyses of drugs prohibited in sports is reviewed. Publications surrounding sporting activities or competitions and others relevant to sports doping are selected. We debate between potential strategies and major limitations of using wastewater monitoring in anti-doping. Knowledge gaps and research directions, specifically on metabolites, stability, sensitivity, and ethical and legal considerations, are discussed. Choosing different wastewater sampling sites allows target sub-population that involved competing athletes and potentially reveal sport-specific or athlete-level-specific behaviour. Sampling from on-board toilets or athlete villages could target international-level athletes, sampling from the dormitories of national training centres allows monitoring of national-level athletes on a daily basis, and sampling from sports stadiums provides a full picture of drug use in the general population during an event. Confounding occurs as (i) the presence of non-athlete composition and the difficulty of analyses to be completely selective to the athlete population; and (ii) the identification of compounds prescribed legitimately with Therapeutic Use Exemptions, only banned in-competition, and naturally occurring. The practicalities of the approach are contextualised in monitoring the non-threshold substances such as anabolic agents, selective androgen receptor modulators, metabolic modulators, and hypoxia-inducible factor activators.

Digital screening and brief intervention for illicit drug misuse in college students: A mixed methods, pilot, cluster, randomized trial from India.

BACKGROUND: Adolescence and early adulthood are vulnerable periods for substance use-related disorders later in life. The use of internet-enabled interventions can be useful, especially in low-resource settings. AIMS: To examine the feasibility, acceptability, and preliminary effectiveness of single-session digital screening and brief intervention (d-SBI) for illicit drug misuse in college students and explore barriers and facilitators of d-SBI. METHODS: Design: Mixed-methods, pilot cluster randomized trial. SETTING: Four conveniently selected colleges were randomized into intervention and control groups. PARTICIPANTS: 219 students were screened, and 37 fulfilled eligibility. Twenty-four completed follow-ups. In-depth interviews were done with ten students. Intervention and Comparator: Following a digital screening, Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) based brief intervention was provided in the d-SBI group. The control group received brief education. MEASUREMENTS: Acceptability was assessed by direct questions and usage statistics. ASSIST scores of groups were assessed at baseline and 3 months. Inductive coding of the interview transcript was done. RESULTS: More than 50 % of participants found d-SBI user-friendly, appropriate, and useful. Eighty percent of users, who logged in, completed screening. Per-protocol analysis showed a reduction in cannabis-ASSIST score over 3 months. The mean ASSIST score for other drugs combined did not differ significantly between groups. The difference in risk transition (moderate to low) was not significant. Qualitative analysis revealed three overarching themes- recruitment, engagement, and behavior change. CONCLUSIONS: Digital SBI for drug misuse is feasible among college students. d-SBI might be effective in reducing cannabis use.

Social Determinants of Alcohol and Other Drug Misuse Among Women Living with HIV in Economically Underserved Communities in Cape Town, South Africa: A Cross-Sectional Study.

This study aimed to understand how social determinants-the economic and social factors that affect health and well-being-are associated with self-reported and biological alcohol and other drug misuse in South Africa among women living with HIV. Logistic regression analyses were performed using baseline data from an implementation science trial conducted from 2015 to 2018 with 480 Black and Coloured women who were living with HIV and reported recent alcohol or other drug misuse. Educational attainment, type of housing, access to running water, food insecurity, and housing instability were examined. Women with higher education had reduced odds of any drug misuse-both biological (aOR: 0.53; 95% CI: 0.33-0.84) and self-reported (aOR: 0.37; 95% CI: 0.22-0.64). Women living in formal housing had increased odds of a positive alcohol screening test (aOR: 1.92; 95% CI: 1.16-3.18) and women with housing instability had increased odds of self-reported alcohol misuse-daily (aOR: 1.99; 95% CI: 1.18-3.35) and weekly (aOR:1.91; 95% CI: 1.19-3.07). Food insecurity was associated with reduced odds of self-reported alcohol misuse (aOR: 0.40; 95% CI: 0.25-0.64) and increased odds of self-reported drug misuse (aOR: 2.05; 95% CI: 1.16-3.61). These findings indicate the complexity of the relationship between social determinants and alcohol and other drug misuse, and may have implications for addressing social and structural determinants as part of multilevel interventions focused on reducing alcohol and other drug misuse among key populations of women in South Africa.

Is it all in the family? Sexual identity differences in DSM-5 alcohol and other drug use disorders and associations with alcohol and other drug misuse history among parents, offspring, and other relatives.

Background: The objectives of this study were to: (1) estimate the prevalence of family history of alcohol and other drug (AOD) misuse (positive family history [FH+]) in first- and second-degree relatives across sexual identity subgroups (i.e., lesbian, gay, bisexual, heterosexual); (2) compare AOD misuse among offspring of sexual minority and heterosexual parents; and (3) examine the relationships between FH+ and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) alcohol use disorder (AUD) and other drug use disorder (ODUD) across sexual identity subgroups. Methods: Data were from the National Epidemiologic Survey on Alcohol and Related Conditions-III (n = 36,309 non-institutionalized U.S. adults aged ≥ 18 years). Data collection occurred in households using structured diagnostic face-to-face interviews during 2012-2013. Results: The presence of FH+ in first- and second-degree relatives was most prevalent among bisexual women relative to all other sexual orientation subgroups. Multivariable regression analyses indicated that the odds of AUD and ODUD were higher among FH+ adults relative to negative family history (FH-) adults. Lesbian and bisexual women had higher odds of AUD compared to heterosexual women, controlling for any FH+; this sexual identity difference was not found for men. There were no significant differences in ODUD between heterosexual FH- men and gay FH- men. We found differences in AOD misuse among offspring of bisexual parents, but not gay or lesbian parents compared to heterosexual parents. Conclusions: Health professionals should consider the higher likelihood of a family history of AOD misuse among sexual minorities, especially bisexual women, when treating these individuals. The lack of differences in AOD misuse among offspring of gay or lesbian parents relative to heterosexual parents warrants attention for legal, policy, and clinical decisions.

Psychosocial Interventions for Alcohol and/or Drug Misuse and Use Disorders in Women: A Systematic Review.

Background: Although men and women who misuse substances have different needs, no rigorous systematic literature review has been conducted examining psychosocial substance use interventions for women across a broad range of types of therapeutic approaches and populations. Materials and Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used to guide this review. English language, peer-reviewed research articles indexed in PubMed, PsycINFO, CINAHL Complete, and Web of Science through May 6, 2021, were searched. Peer-reviewed articles were included in the review if they were written in English; described a randomized controlled trial of a psychosocial intervention to reduce substance misuse and related problems in women; and reported quantitative data on alcohol or illicit drug use as an outcome that was linked to the interventions. Results: A total of 51 articles met eligibility criteria, reflecting a broad array of interventions with different levels of methodological rigor. Several, but not most, interventions were tailored to meet the needs of specific subgroups of women, but evidence regarding the efficacy of tailoring was inconclusive. Overall, 61% of studies reported one or more positive substance-related intervention effects, with target substance (alcohol only vs. other drugs only or both alcohol and other drugs) and intervention dosage associated with intervention success. Conclusions: Fewer studies targeting alcohol only reported one or more positive intervention outcomes. This warrants further study, given that polysubstance use is the norm, not the exception. Future research might also focus on reducing treatment barriers to women, as this has the potential to improve overall treatment outcomes for this population.

Recent trends in prescription drug misuse in the United States by age, race/ethnicity, and sex.

BACKGROUND AND OBJECTIVES: To examine changes in United States past-year opioid, stimulant, and benzodiazepine prescription drug misuse (PDM) and poly-PDM by demographics. METHODS: Data were from the 2015-2019 National Survey on Drug Use and Health (N = 282,768), examining annualized PDM change by demographics. RESULTS: Opioid and poly-PDM significantly declined among those under 35 years, White, and multiracial residents. DISCUSSION AND CONCLUSIONS: Age and race/ethnicity are important moderators of recent PDM trends, warranting investigation of mechanisms. SCIENTIFIC SIGNIFICANCE: Results highlight ongoing PDM declines in younger groups but expand the literature by showing limited changes in adults 35 and older and non-opioid PDM.

Cefalea por abuso de medicamentos y sus marcadores clínicos / Medication overuse headache and its specific clinical markers

Resumen Introducción: Los marcadores clínicos de la cefalea por uso excesivo de medicación (CMA) se basan en la clasificación de las cefaleas desarrollada por la Sociedad Internacional de Cefaleas (IHS). Esta clasificación incluye sólo dos criterios: la frecuencia de los días de cefalea debe ser de 15 o más días al mes durante al menos tres o más meses; - y el número de días de uso excesivo de la medicación debe ser de 10 o 15 días al mes dependiendo del tipo de medicación. Sin embargo, los pacientes suelen tener otros marcadores clínicos asociados distintos, que la mayoría de los médicos pasan por alto durante la evaluación inicial. Metodología: Este estudio es un estudio prospectivo, longitudinal y observacional de 76 pacientes ingresados en la Unidad de Cefaleas del hospital DIPRECA. Todos ellos fueron diagnosticados de HMO según los criterios establecidos por su ICHD III beta.(1) Los pacientes recibieron un tratamiento estándar que incluía desintoxicación y medicación preventiva y fueron seguidos durante 6 meses. Se registraron los síntomas de interés en cada visita de seguimiento clínico y se administraron escalas de evaluación como Zung, MIDAS, HIT-6. Resultados: Los medicamentos sobreutilizados incluyeron antiinflamatorios no esteroideos (AINE), triptanes y cornezuelos. Los síntomas clínicos más significativos asociados fueron: despertar por la mañana con dolor de cabeza, despertar al paciente al amanecer por dolor de cabeza, dificultades de atención, depresión, dolor cervical y síndrome de dolor miofascial. Todos los síntomas mejoraron significativamente al iniciar el tratamiento, al igual que la calidad de vida medida por las escalas MIDAS y HIT-6. Discusión: Al evaluar a los pacientes con HMO, hay que tener en cuenta tanto los criterios diagnósticos de la ICHD III beta como los síntomas comunes y específicos que se observan en la mayoría de los casos de HMO.

Introduction: Clinical markers of medication overuse headache (MOH) are based on headache classification developed by the International Headache Society (IHS). This classification include only two criteria: frequency of headache days must be 15 or more days per month for at least three or more months; - and the number of days of overuse medication must be either 10 or 15 days per month depending on the type of medication. However, patients often have others distinct associated clinical markers, which are overlooked by most physicians during the initial evaluation. Methodology: This study is a prospective, longitudinal and observational study of 76 patients admitted to DIPRECA´s hospital Headache Unit. They were all diagnosed with, MOH according to the criteria established by the his ICHD III beta.(1) Patients were given standard treatment including detoxification and preventive medications and followed for 6 months. Symptoms of interest were recorded in at each clinical monitoring visit and assessment scales such as Zung, MIDAS, HIT-6 were administered. Results: Overused medications included nonsteroidal anti-inflammatory drugs (NSAIDs), triptans and ergots. The most significant clinical symptoms associated were: awaking in the morning with headache, awaking the patient at dawn by headache, attention difficulties, depression, cervical pain and myofascial pain syndrome. All symptoms significantly improved when treatment began, as did quality of life as measured by MIDAS and HIT-6 scales. Discussion: In evaluating patients with MOH consider both the ICHD III beta diagnostic criteria and the common and specific symptoms seen in most cases of MOH.

Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation.

BACKGROUND: The national opioid crisis has disproportionately burdened rural White populations and American Indian/Alaska Native (AI/AN) populations. Therefore, Cherokee Nation and Emory University public health scientists have designed an opioid prevention trial to be conducted in rural communities in the Cherokee Nation (northeast Oklahoma) with AI and other (mostly White) adolescents and young adults. Our goal is to implement and evaluate a theory-based, integrated multi-level community intervention designed to prevent the onset and escalation of opioid and other drug misuse. Two distinct intervention approaches-community organizing, as implemented in our established Communities Mobilizing for Change and Action (CMCA) intervention protocol, and universal school-based brief intervention and referral, as implemented in our established Connect intervention protocol-will be integrated with skill-based training for adults to strengthen social support for youth and also with strategic media. Furthermore, we will test systems for sustained implementation within existing organizational structures of the Cherokee Nation and local schools and communities. This study protocol describes the cluster randomized trial, designed to measure implementation and evaluate the effectiveness on primary and secondary outcomes. METHODS: Using a cluster randomized controlled design and constrained randomization, this trial will allocate 20 high schools and surrounding communities to either an intervention or delayed-intervention comparison condition. With a proposed sample of 20 high schools, all enrolled 10th grade students in fall 2021 (ages 15 to 17) will be eligible for participation. During the trial, we will (1) implement interventions through the Cherokee Nation and measure implementation processes and fidelity, (2) measure opioid and other drug use and secondary outcomes every 6 months among a cohort of high school students followed over 3 years through their transition out of high school, (3) test via a cluster randomized trial the effect of the integrated CMCA-Connect intervention, and (4) analyze implementation costs. Primary outcomes include the number of days during the past 30 days of (1) any alcohol use, (2) heavy alcohol use (defined as having at least four, among young women, or five, among young men, standard alcoholic drinks within a couple of hours), (3) any marijuana use, and (4) prescription opioid misuse (defined as "without a doctor's prescription or differently than how a doctor or medical provider told you to use it"). DISCUSSION: This trial will expand upon previous research advancing the scientific evidence regarding prevention of opioid and other drug misuse during the critical developmental period of late adolescent transition to young adulthood among a sample of American Indian and other youth living within the Cherokee Nation reservation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04839978 . Registered on April 9, 2021. Version 4, January 26, 2022.