BackgroundDespite continuing advancements in treatments for opioid use disorder (OUD), continued high rates of relapse indicate the need for more effective approaches, including novel pharmacological interventions. Glucagon-like peptide 1 receptor agonists (GLP-1RA) provide a promising avenue as a non-opioid medication for the treatment of OUD. Whereas GLP-1RAs have shown promise as a treatment for alcohol and nicotine use disorders, to date, no controlled clinical trials have been conducted to determine if a GLP-1RA can reduce craving in individuals with OUD. The purpose of the current protocol was to evaluate the potential for a GLP-1RA, liraglutide, to safely and effectively reduce craving in an OUD population in residential treatment.MethodThis preliminary study was a randomized, double-blinded, placebo-controlled clinical trial designed to test the safety and efficacy of the GLP-1RA, liraglutide, in 40 participants in residential treatment for OUD. Along with taking a range of safety measures, efficacy for cue-induced craving was evaluated prior to (Day 1) and following (Day 19) treatment using a Visual Analogue Scale (VAS) in response to a cue reactivity task during functional near-infrared spectroscopy (fNIRS) and for craving. Efficacy of treatment for ambient craving was assessed using Ecological Momentary Assessment (EMA) prior to (Study Day 1), across (Study Days 2–19), and following (Study Days 20–21) residential treatment.DiscussionThis manuscript describes a protocol to collect clinical data on the safety and efficacy of a GLP-1RA, liraglutide, during residential treatment of persons with OUD, laying the groundwork for further evaluation in a larger, outpatient OUD population. Improved understanding of innovative, non-opioid based treatments for OUD will have the potential to inform community-based interventions and health policy, assist physicians and health care professionals in the treatment of persons with OUD, and to support individuals with OUD in their effort to live a healthy life. Trial registration: ClinicalTrials.gov: NCT04199728. Registered 16 December 2019, https://clinicaltrials.gov/study/NCT04199728?term=NCT04199728.Protocol Version10 May 2023

BackgroundAlcohol-attributable medical disorders are prevalent among individuals with alcohol use disorder (AUD). However, there is a lack of research on prescriptions of pharmacological treatment for AUD in those with comorbid conditions. This study aims to investigate the utilization of pharmacological treatment (acamprosate, disulfiram and naltrexone) in specialist care among patients with AUD and comorbid medical diagnoses.MethodsThis was a descriptive register-based Swedish national cohort study including 132,728 adults diagnosed with AUD (N = 270,933) between 2007 and 2015. The exposure was alcohol-attributable categories of comorbid medical diagnoses. Odds ratios (OR) were calculated using mixed-effect logistic regression analyses for any filled prescription of acamprosate, disulfiram or oral naltrexone within 12 months post AUD diagnosis.ResultsIndividuals with comorbid alcohol-attributable medical diagnoses had lower odds of filling prescriptions for any type of AUD pharmacotherapy compared to those without such comorbidities. Cardiovascular (OR = 0.41 [95% CI: 0.39–0.43]), neurological (OR = 0.52 [95% CI: 0.48–0.56]) and gastrointestinal (OR = 0.57 [95% CI: 0.54–0.60]) diseases were associated with the lowest rates of prescription receipt. The presence of diagnoses which are contraindications to AUD pharmacotherapy did not fully explain the low prescription rate.ConclusionThere is a substantial underutilization of AUD pharmacotherapy in patients with AUD and comorbid medical disorders in specialist care. Increasing the provision of pharmacotherapy to this group of patients is essential and may prevent morbidity and mortality. There is a need to further understand barriers to medical treatment both from the patient and prescriber perspective.

BackgroundChildren at risk of substance use disorders (SUD) should be detected using brief structured tools for early intervention. This study sought to translate and adapt the Car, Relax, Alone, Forget, Family/Friends, Trouble (CRAFFT) tool to determine its diagnostic accuracy, and the optimum cut-point to identify substance use disorders (SUD) risk in Ugandan children aged 6 to 13 years.MethodsThis was a sequential mixed-methods study conducted in two phases. In the first qualitative phase, in Kampala and Mbale, the clinician-administered CRAFFT tool version 2.1 was translated into the local Lumasaaba dialect and culturally adapted through focus group discussions (FGDs) and in-depth interviews, in collaboration with the tool’s authors. Expert reviews and translations by bilingual experts provided insights on linguistic comprehensibility and cultural appropriateness, while pilot testing with the target population evaluated the tool’s preliminary effectiveness. In the second phase, the CRAFFT tool, adapted to Lumasaaba, was quantitatively validated against the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) for diagnosing SUD in Mbale district, through a survey. Participants, chosen randomly from schools stratified according to ownership, location, and school size, were assessed for the tool’s reliability and validity, including comparisons to the MINI KID as the Gold Standard for diagnosing SUD. Data were analyzed using STATA-15. Receiver-operating-characteristic analysis was performed to determine the sensitivity, specificity, and criterion validity of the CRAFFT with the MINI-KID.ResultsOf the 470 children enrolled, 2.1% (n = 10) had missing data on key variables, leaving 460 for analysis. The median age and interquartile range (IQR) was 11 (9–12) years and 56.6% were girls. A total of 116 (25.2%) children had consumed alcohol in the last twelve-month period and 7 (1.5%) had used other substances. The mean CRAFFT score for all the children (n = 460) was 0.32 (SD 0.95). The prevalence of any alcohol use disorder (2 or more positive answers on the MINI KID) in the last 12 months was 7.2% (n = 32). The Lumasaaba version of the CRAFFT tool demonstrated good internal consistency (Cronbach’s α = 0.86) and inter-item correlation (Spearman correlation coefficient of 0.84 (p < 0.001). At a cut-off score of 1.00, the CRAFFT had optimal sensitivity (91%) and specificity (92%) (Area Under the Curve (AUC) 0.91; 95% CI 0.86–0.97) to screen for SUD. A total of 62 (13.5%) had CRAFFT scores of > 1.ConclusionThe Lumasaaba version of the CRAFFT tool has sufficient sensitivity and specificity to identify school-age children at risk of SUD.

BackgroundSubstance use disorder (SUD) is associated with executive function (EF) deficits and sensory modulation dysfunction (SMD). Yet, these deficits are not addressed therapeutically. This study aims to examine the effectiveness of the Functional-Cognitive and Sensory Treatment (F-CaST) compared to standard care to improve everyday performance and behavior and length of stay at the therapeutic community (TC) in individuals with SUD. In addition, to assess the improvement in EF, sensory modulation, participation, self-efficacy, life satisfaction, and use of strategies within and between groups. Satisfaction with F-CaST will also be assessed.MethodsForty-eight participants from a community of men in a TC, aged 18–45 years will be randomly allocated to (i) F-CaST—(experimental group) providing sensory and EF strategies for improving daily function; (ii) standard care (control group) as provided in the TC. Assessments will be conducted by assessors blind to group allocation at 4 time points: T1- pre-intervention; T2- post-intervention; T3- 1-month follow-up; and T4- 3-month follow-up. Primary outcome measures will be everyday performance, assessed by the Canadian Occupational Performance Measure (COPM), behavior and length of stay in the TC; secondary outcome measures will assess EF, SMD. Semi-structured in-depth qualitative interviews will be conducted at T1, T2 and T4.DiscussionWe hypothesize that F-CaST will lead to improved everyday performance and longer length of stay in the TC, compared to the control group. If F-CaST will prove to be effective, cognitive and sensory strategies may be incorporated as an adjunctive intervention in SUD rehabilitation.Trial registration: ClinicalTrials.gov NCT05647863 Registered on 13 December 2022, https://classic.clinicaltrials.gov/ct2/show/NCT05647863.

BackgroundPharmacists play a key role in combating the opioid-related overdose epidemic in the United States (US), but little is known about their experience and willingness to deliver preventive services for opioid use disorder (OUD).AimsThis study seeks to identify correlates of pharmacists’ concerns about drug use problems (prescription drug misuse/use disorder and illicit drug use/use disorder) as well as their practice experience delivering preventive services for OUD (e.g., asked about opioid use, provided advice, made a referral) and willingness to provide services to patients with drug use problems.DesignAn online survey of licensed US pharmacists was conducted. Participants were recruited from Community Pharmacy Enhanced Services Networks (CPESN) and state pharmacist associations (N = 1146).FindingsOverall, 75% of surveyed pharmacists indicated having concerns about opioid use problems, and 62% had concerns about non-opioid drug use problems at their pharmacies. Pharmacists who were White, practiced at a rural location, worked at a chain pharmacy, had not received opioid-related training in the past year, or practiced screening patients for opioid use had elevated odds of perceiving concerns about opioid use problems in their practice settings. Pharmacists who were White, practiced at a rural location, or had not received opioid-related training in the past year had elevated odds of perceiving concerns about non-opioid (illicit) drug use problems. Being male, being White, or having received opioid-related training were associated with increased odds of screening patients for opioid use problems. Being White, having practiced at a rural location (vs. an urban location), being a pharmacy owner/manager, or having received opioid-related training were associated with increased odds of delivering opioid-related advice/intervention. Being male or having received opioid-related training were associated with increased odds of making a referral to OUD treatment. Finally, being male, being White, having practiced pharmacy services for under 6 years, having received opioid-related training for 2 h in the past year, or having performed OUD-related preventive services (asked about opioid use, provided advice, or made a referral) were associated with increased levels of commitment/readiness for providing care to patients with drug use problems.ConclusionsThe overall findings highlight pharmacists’ involvement with OUD preventive services. It is critical to promote opioid-related preventive service training for pharmacists and provide incentives/tools to help initiate a structured practice of delivering such preventive services.

BackgroundPotential differences in buprenorphine treatment outcomes across various treatment settings are poorly characterized in multi-state administrative data. We thus evaluated the association of opioid use disorder (OUD) treatment setting and insurance type with risk of buprenorphine discontinuation among commercial insurance and Medicaid enrollees initiated on buprenorphine.MethodsIn this observational, retrospective cohort study using the Merative MarketScan databases (2006–2016), we analyzed buprenorphine retention in 58,200 US adults with OUD. Predictor variables included insurance status (Medicaid vs commercial) and treatment setting, operationalized as substance use disorder (SUD) specialty treatment facility versus outpatient primary care physicians (PCPs) versus outpatient psychiatry, ascertained by linking physician visit codes to buprenorphine prescriptions. Treatment setting was inferred based on timing of prescriber visit claims preceding prescription fills. We estimated time to buprenorphine discontinuation using multivariable cox regression.ResultsAmong enrollees with OUD receiving buprenorphine, 26,168 (45.0%) had prescriptions from SUD facilities without outpatient buprenorphine treatment, with the remaining treated by outpatient PCPs (n = 23,899, 41.1%) and psychiatrists (n = 8133, 13.9%). Overall, 50.6% and 73.3% discontinued treatment at 180 and 365 days respectively. Buprenorphine discontinuation was higher among enrollees receiving prescriptions from SUD facilities (aHR = 1.03[1.01–1.06]) and PCPs (aHR = 1.07[1.05–1.10]). Medicaid enrollees had lower buprenorphine retention than those with commercial insurance, particularly those receiving buprenorphine from SUD facilities and PCPs (aHR = 1.24[1.20–1.29] and aHR = 1.39[1.34–1.45] respectively, relative to comparator group of commercial insurance enrollees receiving buprenorphine from outpatient psychiatry).ConclusionBuprenorphine discontinuation is high across outpatient PCP, psychiatry, and SUD treatment facility settings, with potentially lower treatment retention among Medicaid enrollees receiving care from SUD facilities and PCPs.

BackgroundAs the opioid epidemic continues to have a major negative impact across the US, community pharmacies have come under scrutiny from legal systems attempting to hold them accountable for their role in over dispensing and lack of patient intervention. While the most available tool for monitoring patients’ opioid use is Prescription Drug Monitoring Programs (PDMP), these do not provide pharmacists with actionable information and decision support. Our study addresses this gap through three objectives: [1] incorporate validated opioid risk metric thresholds into a PDMP platform to create the Opioid Risk Reduction Clinical Decision Support (ORRCDS) tool; [2] assess ORRCDS’ ability to reduce patient opioid risk; [3] assess ORRCDS’ sustainability and viability for broader dissemination in community pharmacy.MethodsFor objective 1, our team is partnering with leadership from the largest US PDMP organization and a top-five pharmacy chain to implement ORRCDS into the pharmacy chain’s workflow following the Guideline Implementation with Decision Support (GUIDES) framework. For objective 2, our team will conduct a type-1 implementation mixed methods study using a 2-arm parallel group clustered randomized design. We anticipate enrolling ~ 6,600 patients with moderate and high opioid use risk during the 6-month enrollment phase across 80 pharmacies. This sample size will provide 96.3% power to detect a 5% or greater difference in responder rate between the intervention and control arm. Responders are patients with moderate-risk at baseline who reduce to low-risk or those with high-risk at baseline who reduce to moderate or low-risk at 180 days post last intervention. To accomplish objective 3, we will use the Consolidated Framework for Implementation Research (CFIR) to develop and execute cross-sectional qualitative interviews with pharmacists (n = 15), pharmacy leaders (n = 15), and PDMP leaders (n = 15) regarding long term adoption and sustainability of the ORRCDS tool.ConclusionsA PDMP tool that addresses moderate- and high-risk opioid use is not available in community pharmacy. This study will implement ORRCDS in a large retail pharmacy chain that will include additional screening and guidance to pharmacy staff to address risky opioid medication use. Our results will make critical advancements for protecting patient health and addressing the opioid epidemic.

IntroductionEmergency 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.MethodsA 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.ResultsA 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 16 months (range 12 to 36 months). 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.ConclusionsThe 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.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13722-024-00453-x.

BackgroundThis study aimed to synthetize the evidence on the effectiveness of harm minimization interventions on reducing blood-borne infection transmission and injecting behaviors among people who inject drugs (PWID) through a comprehensive overview of systematic reviews and evidence gap mapping.MethodsA systematic review was conducted with searches in PubMed and Scopus to identify systematic reviews assessing the impact of interventions aimed at reducing the harms associated with injectable drug use. The overall characteristics of the studies were extracted and their methodological quality was assessed using AMSTAR-2. An evidence gap map was constructed, highlighting the most frequently reported outcomes by intervention (CRD42023387713).ResultsThirty-three systematic reviews were included. Of these, 14 (42.2%) assessed the impact of needle/syringe exchange programs (NSEP) and 11 (33.3%) examined opioid agonist therapy (OAT). These interventions are likely to be associated with reductions of HIV/HCV incidence (10–40% risk reduction for NSEP; 50–60% for OAT) and sharing injecting paraphernalia (50% for NSEP, 25–85% for OAT), particularly when combined (moderate evidence). Behavioral/educational interventions were assessed in 12 reviews (36.4%) with most authors in favor/partially in favor of the use of these approaches (moderate evidence). Take-home naloxone programs and supervised-injection facilities were each assessed in two studies (6.1%), which reported inconclusive results (limited/inconsistent evidence). Most authors reported high levels of heterogeneity and risk of bias. Other interventions and outcomes were inadequately reported. Most systematic reviews presented low or critically low quality.ConclusionThe evidence is sufficient to support the effectiveness of OAT, NSEP and their combination in reducing blood-borne infection transmission and certain injecting behaviors among PWID. However, evidence of other harm minimizations interventions in different settings and for some outcomes remain insufficient.

BackgroundMedications for opioid use disorder (MOUD) are associated with positive health outcomes. People remaining on MOUD have a reduced likelihood of drug overdose and mortality. Tanzania supports a national opioid treatment program (OTP) offering MOUD, but retention is a continual challenge. To date, most research on MOUD retention in Tanzania and other Sub-Saharan Africa settings has been focused on the individual-level, with little attention to economic, social, and clinic-level factors.MethodsWe qualitatively examined economic, social, and clinic factors that affect retention on MOUD, specifically methadone maintenance therapy, among former and current clients attending an OTP clinic Dar es Salaam, Tanzania. We conducted in-depth interviews with a total of 40 current and former clients receiving MOUD and four focus groups with an additional 35 current clients on MOUD between January and April 2020. We utilized a thematic analysis approach.ResultsDaily OTP clinic attendance posed a financial burden to current and former clients and was a barrier to remaining on MOUD. Though treatment is free, clients described struggles to attend clinic, including being able to afford transportation. Female clients were differentially impacted, as sex work was the most common income-generating activity that they participated in, which presented its own set of unique challenges, including barriers to attending during set clinic hours. Drug use stigma acted as a barrier to MOUD and prevented clients from securing a job, rebuilding trust within the community, and accessing transportation to attend the clinic. Being able to rebuild trust with family facilitated remaining on MOUD, as family provided social and financial support. Caretaking responsibilities and familial expectations among female clients conflicted with MOUD adherence. Finally, clinic level factors, such as clinic dispensing hours and punitive consequences for breaking rules, posed barriers to clients on MOUD.ConclusionSocial and structural factors, both within (e.g., clinic policies) and outside of (e.g., transportation) the clinic impact MOUD retention. Our findings can inform interventions and policies to address economic and social barriers to MOUD, that can contribute to sustained recovery.