Real-world experience with circulating tumor DNA in cerebrospinal fluid from patients with central nervous system tumors.

The characterization of genetic alterations in tumor samples has become standard practice for many human cancers to achieve more precise disease classification and guide the selection of targeted therapies. Cerebrospinal fluid (CSF) can serve as a source of tumor DNA in patients with central nervous system (CNS) cancer. We performed comprehensive profiling of CSF circulating tumor DNA (ctDNA) in 711 patients using an FDA-authorized platform (MSK-IMPACT™) in a hospital laboratory. We identified genetic alterations in 489/922 (53.0%) CSF samples with clinically documented CNS tumors. None of 85 CSF samples from patients without CNS tumors had detectable ctDNA. The distribution of clinically actionable somatic alterations was consistent with tumor-type specific alterations across the AACR GENIE cohort. Repeated CSF ctDNA examinations from the same patients identified clonal evolution and emergence of resistance mechanisms. ctDNA detection was associated with shortened overall survival following CSF collection. Next-generation sequencing of CSF, collected through a minimally invasive lumbar puncture in a routine hospital setting, provides clinically actionable cancer genotype information in a large fraction of patients with CNS tumors.

Providers' knowledge and perception of xylazine in the unregulated drug supply: a sequential explanatory mixed-methods study.

BACKGROUND: Xylazine is increasingly prevalent in the unregulated opioid supply in the United States. Exposure to this adulterant can lead to significant harm, including prolonged sedation and necrotic wounds. In the absence of literature describing healthcare providers' experiences with treating patients who have been exposed to xylazine, we aimed to explore what gaps must be addressed to improve healthcare education and best practices. METHODS: From October 2023 to February 2024, we conducted a sequential explanatory mixed-methods study, with (1) a quantitative survey phase utilizing convenience sampling of healthcare providers treating patients in Connecticut and (2) a qualitative semi-structured interview phase utilizing purposive sampling of providers with experience treating patients with xylazine exposure. Summary statistics from the survey were tabulated; interview transcripts were analyzed using thematic analysis. RESULTS: Seventy-eight eligible healthcare providers participated in our survey. Most participants had heard of xylazine (n = 69, 95.8%) and had some knowledge about this adulterant; however, fewer reported seeing one or more patients exposed to xylazine (n = 46, 59.8%). After sampling from this subgroup, we conducted fifteen in-depth interviews. This qualitative phase revealed five themes: (1) while xylazine is novel and of concern, this is not necessarily exceptional (i.e., there are other emerging issues for patients who use drugs); (2) participants perceived that xylazine was increasingly prevalent in the drug supply, even if they were not necessarily seeing more patients with xylazine-related outcomes (XROs); (3) patients primarily presented with non-XROs, making it difficult to know when conversations about xylazine were appropriate; (4) patients with XROs may experience issues accessing healthcare; (5) providers and their patients are learning together about how to minimize XROs and reduce the sense of helplessness in the face of a novel adulterant. CONCLUSIONS: Xylazine-specific education for healthcare providers is currently insufficient. Improving this education, as well as resources (e.g., drug checking technologies) and data (e.g., research on prevention and treatment of XROs), is crucial to improve care for patients who use drugs.

In Support of the Decriminalization of Personal Drug and Paraphernalia Use and Possession: Position Statement of AMERSA, Inc (Association for Multidisciplinary Education, Research, Substance Use and Addiction).

More than 25% of all arrests made nationwide are related to drug offenses, affecting almost 1.2 million people and their social networks. Furthermore, roughly 20% of people in jails and prisons across the United States are incarcerated for a drug offense and millions more are under community supervision for these charges. This criminalization of drug use has negatively affected the health and well-being of people who use drugs (PWUD) and their communities. Decriminalization-a process of removing criminal sanctions for a previously criminalized behavior-of drug use is central to harm reduction as it mitigates these negative consequences of drug use and supports the health of PWUD. As such, AMERSA supports the decriminalization of drug and paraphernalia possession for personal use for all currently illicit drugs and all associated equipment. AMERSA continues to strongly advocate for the funding of harm reduction strategies and addiction services to improve the health and well-being of PWUD since decriminalization without complementary funding for harm reduction services, addiction treatment services, and social safety nets will be incomplete.

Postrelease Risk of Overdose and All-Cause Death Among Persons Released From Jail or Prison: Minnesota, March 2020-December 2021.

Objectives. To determine mortality risk among those recently released from a Minnesota jail or prison. Methods. Using linked prison, jail, and death records, our retrospective cohort study followed 99 065 people who were released from Minnesota jails and prisons between March 1, 2020, and December 31, 2021. We explored differences between jail and prison exposures regarding mortality using standardized mortality ratios. Results. Adjusting for age and gender, we estimated that the rate of overdose death for people released from jail was 15.5 times that of the Minnesota general population. Overdose death rates for people released from prison were even higher at 28.3 times the rate of the Minnesota general population. Conclusions. Drug overdose was the leading cause of death for people reentering their communities from both jail and prison in Minnesota-with opioids being the leading cause of overdoses. Overdose death relative to the general population was double the estimates from earlier studies among people leaving prison. Providing seamless access to medications for opioid use disorder during and after incarceration is important to lower the risk of death following release. (Am J Public Health. 2024;114(9):913-922. https://doi.org/10.2105/AJPH.2024.307723).

Use of Cannabinoids by People Who Consume Kratom in the United States.

OBJECTIVES: To estimate lifetime, past-year, and past-month prevalence of kratom, cannabis, and cannabidiol-only product use among adults 18 years and older in the United States, using 2 independent datasets. METHODS: Utilizing (a) the 2022 National Survey on Drug Use and Health (NSDUH) and (b) a 2022 online national convenience sample of adults who use kratom regularly (from our research group at the National Institute on Drug Abuse [NIDA]), we examined key demographic information as well as lifetime, past-year, and past-month substance use and preferences. RESULTS: Among the full sample of adults from the 2022 NSDUH, the prevalence of lifetime use was 49.69% for cannabis, 34.09% for cannabidiol-only products, and 1.93% for kratom. When solely examining participants who have used kratom, both independent datasets showed higher proportions of cannabis use over the lifetime-92.81% (95% confidence interval: 90.31-95.31) in the NSDUH subset and 92.16% (95% confidence interval: 89.37-94.95) in our NIDA sample. CONCLUSIONS: Our study demonstrates that people are co-using kratom with cannabis and/or cannabidiol-only products at the same time or during the same time period, though more research is needed to understand people's motivations and practices for such co-use. Co-use might result in herb-herb interactions that may impact research findings and clinical outcomes for people who use kratom.

In Support of Overdose Prevention Centers: Position Statement of AMERSA, Inc (Association for Multidisciplinary Education and Research in Substance Use and Addiction).

Given increasing rates of fatal overdoses in the United States and the rapidly changing drug supply, overdose prevention centers (OPCs; also known as safe consumption sites) have been identified as a vital, evidence-based strategy that provide people who use drugs (PWUD) the opportunity to use drugs safely and receive immediate, life-saving overdose support from trained personnel. In addition to providing a safe, supervised space to use drugs, OPCs can house further essential harm reduction drop-in services such as sterile supplies, social services, and medical care. There are established national and international data demonstrating the lifesaving services provided by OPCs, inspiring a groundswell of advocacy efforts to expand these programs in the United States. Thus, the Association for Multidisciplinary Education and Research in Substance Use and Addiction (AMERSA) endorses OPCs, in addition to other harm reduction strategies that protect PWUD. Ultimately, it is imperative to increase access to OPCs across the United States and support key policy changes at the local, state, and federal levels that would facilitate urgent expansion.

Kratom addiction per DSM-5 SUD criteria, and kratom physical dependence: Insights from dosing amount versus frequency.

BACKGROUND: Kratom products are widely used in the United States, with inadequate understanding of how dosing amounts/frequencies relate to outcomes. METHODS: Between July-November 2022, we enrolled 395 active US adult kratom consumers into a remote study with a baseline survey. We examined self-reported typical dose amounts and frequencies across people and product types, and their associations with outcomes: multiple regression was used to examine whether amounts and frequencies (doses/day) were associated with acute effects, withdrawal symptoms, scores on the Subjective Opioid Withdrawal Scale (SOWS), and addiction (operationalized as DSM-5-based symptoms of kratom-use disorder, KUD). RESULTS: Participants were 54.9% male, aged 38.1 on average, and 81.3% White. Mean length of kratom use was 5.7 years. Most (95.9%) reported regularly using whole-leaf kratom products; 16 (4.1%) reported regular extract use. SOWS scores were mild to moderate on average (13.5, SD 11.9). KUD symptom counts were mostly in the mild/moderate range (80.7%). Withdrawal and KUD symptoms were more closely associated with dose frequency than dose amount. Men reported more acute effects, withdrawal symptoms with cessation, and KUD symptoms than women. CONCLUSIONS: Greater dose amount and frequency were systematically related to the number of withdrawal symptoms upon cessation and to KUD symptoms; the relationship was stronger for dose frequency than amount. Men may have more acute effects and more withdrawal and KUD symptoms than women. Although kratom may be used nonproblematically by some consumers, physical dependence (tolerance, withdrawal, or use to avoid withdrawal) and KUD become more likely with increasing dose frequency.

Delays in Care by Race, Ethnicity, and Gender Before and During the COVID-19 Pandemic Using Cross-Sectional Data From the National Institutes of Health's All of Us Research Program.

PURPOSE: Delays in receiving medical care are an urgent problem. This study aims to determine whether the odds of, and reasons for, experiencing care delays differ by gender, race-ethnicity, and survey completion before versus during the COVID-19 pandemic. METHODS: We conducted a cross-sectional analysis of survey data from participants age ≥18 in the National Institutes of Health's All of Us Research Program collected from May 6, 2018, to January 1, 2022. Logistic regressions were performed to assess the association of gender, race-ethnicity, and survey completion date with any of nine reasons for delaying care in the past 12 months. RESULTS: Of 119,983 participants, 37.8% reported delaying care in the past 12 months. After adjusting for employment status, education, income, marital status, health insurance, and age, women of every race-ethnicity and Black and other race-ethnicity men were more likely than white men to report delays in care: Asian women (odds ratio [OR] 1.23; 95% confidence interval [CI] [1.13, 1.34]), Black men (OR 1.15; 95% CI [1.05, 1.25]) and women (OR 1.46; 95% CI [1.38, 1.54]), Hispanic women (OR 1.36; 95% CI [1.28, 1.44]), white women (OR 1.55; 95% CI [1.50, 1.60]), and other race-ethnicity men (OR 1.15; 95% CI [1.05, 1.27]) and women (OR 1.79; 95% CI [1.67, 1.91]). A small but statistically significant difference was seen in reports of care delays for non-pandemic-related reasons during versus before the COVID-19 pandemic (OR 0.88; 95% CI [0.83, 0.93]). CONCLUSIONS: In this study of a diverse group of U.S. participants, women and Black and other race-ethnicity men were more likely than white men to report delays in care, both before and during COVID-19. Addressing care delays may be necessary to ameliorate health disparities by race-ethnicity and gender.

Prevalence of Kratom Use Disorder Among Kratom Consumers.

OBJECTIVES: Kratom leaf products are increasingly consumed in the United States, with many consumers reporting they experience beneficial effects from kratom use. However, there is a growing concern for kratom's potential to result in dependence when used regularly. As such, we sought to assess, using Diagnostic and Statistical Manual of Mental Disorders , (DSM-5) , diagnostic criteria for substance use disorder, the prevalence of "kratom use disorder" (KUD) among kratom consumers. METHODS: Our cross-sectional study used an online, anonymous survey between February and May 2023. Through nonprobability sampling, we recruited people older than 18 years who currently consume kratom. Participants were asked about their kratom consumption patterns, adverse effects perceived to stem from kratom consumption, comorbid diagnoses, and components for a DSM-5 , substance use disorder, adapted for kratom. RESULTS: Among the total sample ( N = 2061), KUD criteria were met by 25.5% of participants ( n = 525); the most commonly reported symptoms were tolerance ( n = 427, 81.3%) and withdrawal ( n = 357, 68.0%). After adjusting for age, gender, daily frequency of kratom consumption, and history of either a substance use disorder or a mental health condition, those with a concurrent diagnosis of another substance use disorder had 2.83 times higher odds of meeting KUD criteria (95% CI, 2.19-3.67) compared with those without one. CONCLUSIONS: In this large cross-sectional study, most participants who met the criteria for a KUD diagnosis were categorized as having a mild or moderate KUD. Individual characteristics associated with KUD were related to being male, young, consuming kratom frequently, and having psychiatric and substance use disorder comorbidities.

Development of a Tool to Measure Student Perceptions of Equity and Inclusion in Medical Schools.

Importance: Creating an inclusive and equitable learning environment is a national priority. Nevertheless, data reflecting medical students' perception of the climate of equity and inclusion are limited. Objective: To develop and validate an instrument to measure students' perceptions of the climate of equity and inclusion in medical school using data collected annually by the Association of American Medical Colleges (AAMC). Design, Setting, and Participants: The Promoting Diversity, Group Inclusion, and Equity tool was developed in 3 stages. A Delphi panel of 9 members identified survey items from preexisting AAMC data sources. Exploratory and confirmatory factor analysis was performed on student responses to AAMC surveys to construct the tool, which underwent rigorous psychometric validation. Participants were undergraduate medical students at Liaison Committee on Medical Education-accredited medical schools in the US who completed the 2015 to 2019 AAMC Year 2 Questionnaire (Y2Q), the administrations of 2016 to 2020 AAMC Graduation Questionnaire (GQ), or both. Data were analyzed from August 2020 to November 2023. Exposures: Student race and ethnicity, sex, sexual orientation, and socioeconomic status. Main Outcomes and Measures: Development and psychometric validation of the tool, including construct validity, internal consistency, and criterion validity. Results: Delphi panel members identified 146 survey items from the Y2Q and GQ reflecting students' perception of the climate of equity and inclusion, and responses to these survey items were obtained from 54 906 students for the Y2Q cohort (median [IQR] age, 24 [23-26] years; 29 208 [52.75%] were female, 11 389 [20.57%] were Asian, 4089 [7.39%] were multiracial, and 33 373 [60.28%] were White) and 61 998 for the GQ cohort (median [IQR] age, 27 [26-28] years; 30 793 [49.67%] were female, 13 049 [21.05%] were Asian, 4136 [6.67%] were multiracial, and 38 215 [61.64%] were White). Exploratory and confirmatory factor analyses of student responses identified 8 factors for the Y2Q model (faculty role modeling; student empowerment; student fellowship; cultural humility; faculty support for students; fostering a collaborative and safe environment; discrimination: race, ethnicity, and gender; and discrimination: sexual orientation) and 5 factors for the GQ model (faculty role modeling; student empowerment; faculty support for students; discrimination: race, ethnicity, and gender; and discrimination: sexual orientation). Confirmatory factor analysis indicated acceptable model fit (root mean square error of approximation of 0.05 [Y2Q] and 0.06 [GQ] and comparative fit indices of 0.95 [Y2Q] and 0.94 [GQ]). Cronbach α for individual factors demonstrated internal consistency ranging from 0.69 to 0.92 (Y2Q) and 0.76 to 0.95 (GQ). Conclusions and Relevance: This study found that the new tool is a reliable and psychometrically valid measure of medical students' perceptions of equity and inclusion in the learning environment.

In Support of Community Drug Checking Programs: Position Statement of AMERSA, Inc. (Association for Multidisciplinary Education and Research in Substance use and Addiction).

BACKGROUND: Position statements clarify key issues that are in alignment with the vision, mission, and values of the AMERSA, Inc. (Association for Multidisciplinary Education and Research in Substance use and Addiction). This Position Statement, endorsed by the AMERSA Board of Directors on October 3, 2023, amplifies the position of the organization, guides their activities, and informs the public and policymakers on the organization's stance on this issue. ISSUE: The unregulated drug supply in the United States evolves constantly, leaving those who use drugs potentially unaware of new adulterants in their drugs. Not knowing that information can leave people vulnerable to serious adverse events such as fatal overdoses, wounds, and other health consequences. Without real-time data on the composition of drugs available in a community, healthcare providers and public health practitioners are left with insufficient data, making it increasingly difficult to know how to best serve people who use drugs. In this context, community-based drug checking has become recognized as an important harm reduction strategy with the potential to provide those who use drugs with more information about their supply. RECOMMENDATIONS: It is imperative to expand funding and increase access to drug checking programs in communities across the United States. Key policy changes, such as those related to decriminalizing drug and drug paraphernalia possession, are needed to increase the utilization of drug checking programs. Protection of persons who use drugs through harm reduction strategies, including drug checking programs needs to be widely available and accessible.

Compliance with Influenza Vaccination and Cervical, Breast, and Colorectal Cancer Screening in a Sample of Women in Puerto Rico: Community Engagement Efforts from PR-CEAL.

OBJECTIVE: There are an estimated 5,570 yearly cancer deaths in Puerto Rico. Breast and colorectal are the most common malignancies among Puerto Rican women. Therefore, prevention and early detection of these cancer types are critical to reducing morbidity and mortality. This study assessed whether women who received the influenza vaccine had increased adherence to cervical, breast, and colorectal cancer screening. METHODS: The Puerto Rico Community Engagement Alliance (PR-CEAL) against COVID-19 Disparities team attended community outreach events throughout Puerto Rico and completed a face-to-face survey among women 18 years or older. The survey gathered demographic information and adherence to influenza vaccination and cervical, breast, and colorectal screening in the past year. The initial sample included 400 women, of whom 347 met the age inclusion criteria (21-74 years). Chi-square tests were used to compare cancer screening adherence according to influenza vaccination status. A p-value <0.05 was considered statistically significant. RESULTS: Of all participants, 47.0% received the influenza vaccine in the past year. Cancer screening rates among vaccinated and non-vaccinated women were as follows: 64.5% vs. and 13.0% vs. 8.0% for colorectal cancer (p-value=0.19). CONCLUSION: Adherence to cervical, breast, and colorectal cancer screening in the past year did not differ by influenza vaccination status. Influenza vaccination appointments may therefore represent a missed opportunity to promote preventative cancer screening in Puerto Rico.

"It's starting to weigh on me": Exploring the Experiences and Support Needs of Harm Reduction Staff in Connecticut using the Social-Ecological Model.

BACKGROUND: The experiences and perceived support needs of harm reduction workers in the USA have been understudied. While previous research has explored staff burnout and role-related stress, there is a research gap around potential supports for staff wellbeing and individual longevity in their roles. This is especially critical given the growing overdose crisis and the need for sustainable harm reduction programming. Thus, we sought to describe the experiences of harm reduction staff and identify the perceived support that could empower harm reduction staff to successfully navigate their roles. METHODS: Purposive sampling methods were used to recruit harm reduction staff working in Connecticut. Seventeen semi-structured, one-on-one interviews were conducted between December 2022 and March 2023. Participants were asked about their experiences with role-related stressors and supports. Informed by the Social-Ecological Model, transcripts were coded using both inductive and deductive codes, and themes were developed using thematic analysis approaches. RESULTS: Study participants described their experiences working in harm reduction and the numerous ways they already are or could be receiving support in their roles. These experiences were organized into eight themes according to the levels of the Social-Ecological Model. At the individual level, participants explained that support could help them navigate the variability of the physical environment, boundary setting, and self-care. Relationships between clients and co-workers were both identified as means of support at the interpersonal level, helping participants navigate difficult situations and feelings of stress. At the organizational level, study participants explained how they look to their organization to provide sufficient support by way of training, staffing, compensation, and benefits. Additionally, participants stressed the importance of having supervisors who valued their work and provided emotional support. Lastly, at the community level, participants discussed how support was needed to help them navigate complex systems while working with a stigmatized population in an often-stigmatized field. CONCLUSIONS: To best support harm reduction staff in their day-to-day roles, our findings underscore the need for support on multiple levels. Future research could explore how the provision of support to harm reduction staff impacts not only staff perceptions of support but also the success of clients accessing harm reduction services.

Integrated Care Models: HIV and Substance Use.

PURPOSE OF REVIEW: Behaviors and practices associated with substance use contribute to lack of HIV virologic suppression and onward transmission. In the USA, many recent HIV outbreaks have been connected with substance use. Evidence-based strategies for integrating care of those at risk for and living with HIV and who use substances continue to evolve. This review, based on scientific and medical literature through March 2023, provides an overview and evaluation of initiatives for integrated care aimed to serve patients at risk for and with HIV and a substance use disorder. RECENT FINDINGS: Integrated care services can improve health outcomes for patients at risk for and with HIV and a substance use disorder; for instance, treatment for an opioid use disorder can help improve HIV viral suppression. Brick-and-mortar facilities can provide successful care integration with appropriate clinic leadership to support multidisciplinary care teams, up-to-date provider training, and sufficient pharmacy stock for substance use treatment. Delivering healthcare services to communities (e.g., mobile healthcare clinics and pharmacies, telehealth) may prove to be an effective way to provide integrated services for those with or at risk of HIV and substance use disorders. Incorporating technology (e.g., mobile phone applications) may facilitate integrated care. Other venues, including harm reduction programs and carceral settings, should be targets for integrated services. Venues providing healthcare should invest in integrated care and support legislation that increases access to services related to HIV and substance use.

Extracellular matrix composition affects outgrowth of dendrites and dendritic spines on cortical neurons.

The composition of the extracellular matrix (ECM) in nervous tissue plays an important role in controlling neuronal outgrowth and synapse development. Changes in both protein and glycosaminoglycan components of the ECM occur with tissue injury and may affect neuron growth. To investigate neuron responses to alterations in fibronectin (FN), a major component of the wound ECM, we grew cortical neurons on cell-derived decellularized matrices composed of wild type FN (FN+/+) or of a mutant form of FN (FNΔ/+) from which the III13 heparin-binding site had been deleted by CRISPR-Cas 9 gene editing. The most significant effect of the mutant FN was a reduction in dendrite outgrowth. Not only were dendrites shorter on mutant FNΔ/+-collagen (COL) matrix than on wild type (FN+/+-COL) matrix, but the number of dendrites and dendritic spines per neuron and the spine densities were also dramatically reduced on FNΔ/+-COL matrices. Mass spectrometry and immunostaining identified a reduction in tenascin-C (TN-C) levels in the mutant matrix. TN-C is an ECM protein that binds to the III13 site of FN and modulates cell-matrix interactions and has been linked to dendrite development. We propose that TN-C binding to FN in the wound matrix supports dendrite and spine development during repair of damaged neural tissue. Overall, these results show that changes in ECM composition can dramatically affect elaboration of neurites and support the idea that the ECM microenvironment controls neuron morphology and connectivity.

Clinical outcome of pediatric medulloblastoma patients with Li-Fraumeni syndrome.

BACKGROUND: The prognosis for Li-Fraumeni syndrome (LFS) patients with medulloblastoma (MB) is poor. Comprehensive clinical data for this patient group is lacking, challenging the development of novel therapeutic strategies. Here, we present clinical and molecular data on a retrospective cohort of pediatric LFS MB patients. METHODS: In this multinational, multicenter retrospective cohort study, LFS patients under 21 years with MB and class 5 or class 4 constitutional TP53 variants were included. TP53 mutation status, methylation subgroup, treatment, progression free- (PFS) and overall survival (OS), recurrence patterns, and incidence of subsequent neoplasms were evaluated. RESULTS: The study evaluated 47 LFS individuals diagnosed with MB, mainly classified as DNA methylation subgroup "SHH_3" (86%). The majority (74%) of constitutional TP53 variants represented missense variants. The 2- and 5-year (y-) PFS were 36% and 20%, and 2- and 5y-OS were 53% and 23%, respectively. Patients who received postoperative radiotherapy (RT) (2y-PFS: 44%, 2y-OS: 60%) or chemotherapy before RT (2y-PFS: 32%, 2y-OS: 48%) had significantly better clinical outcome then patients who were not treated with RT (2y-PFS: 0%, 2y-OS: 25%). Patients treated according to protocols including high-intensity chemotherapy and patients who received only maintenance-type chemotherapy showed similar outcomes (2y-PFS: 42% and 35%, 2y-OS: 68% and 53%, respectively). CONCLUSIONS: LFS MB patients have a dismal prognosis. In the presented cohort use of RT significantly increased survival rates, whereas chemotherapy intensity did not influence their clinical outcome. Prospective collection of clinical data and development of novel treatments are required to improve the outcome of LFS MB patients.

Correlations of kratom (Mitragyna speciosa Korth.) tea bag preparations and reported pharmacological effects.

ETHNOPHARMACOLOGICAL RELEVANCE: The use of herbal tea infusions is widespread in ethnomedicine throughout the world. One such ethnobotanical is kratom (Mitragyna speciosa Korth., Rubiaceae) which has gained considerable interest as an herbal supplement in recent years in the West beyond its native Southeast Asia. Traditional, kratom leaves are either chewed fresh or made into a tea infusion to treat fatigue, pain, or diarrhea. However, dried kratom leaf powder and hydroalcoholic extracts are more commonly used in Western countries, raising the question of exposure to kratom alkaloids and related effects. AIM OF THE STUDY: A specific kratom tea bag product was analyzed for mitragynine content using tea infusion preparation and methanolic extraction. Consumers of both the tea bag product and other kratom products completed an online anonymous survey to determine demographics, kratom use patterns, and self-reported beneficial and detrimental effects. MATERIALS AND METHODS: Kratom tea bag samples were extracted using pH-adjusted water or methanol and analyzed using an established LC-QTOF method. A modified kratom survey was distributed to consumers of the kratom tea bag products and other kratom products over a 14-month period. RESULTS: Tea infusion extraction of tea bag samples resulted in lower mitragynine levels (0.062-0.131% (w/w)) compared to methanolic extraction (0.485-0.616% (w/w)). Kratom tea bag consumers did report similar, although often milder beneficial effects compared to consumers using other kratom products. Overall self-reported health was better among kratom tea bag consumers whereas improvement of a diagnosed medical condition was less in tea bag consumers compared to those using other kratom products. CONCLUSIONS: Traditional tea infusions of Mitragyna speciosa dried leaves provide benefits to consumers despite substantially lower mitragynine content. These effects may be less pronounced but indicate that tea infusions provide a potentially safer formulation compared to more concentrated products.

Evaluating health information provided to kratom consumers by good manufacturing practice-qualified vendors.

BACKGROUND: "Kratom" commonly refers to the botanical Mitragyna speciosa, native to Southeast Asia, which is increasingly used globally for its unique pharmacological effects. Motives for using the whole plant material or kratom-derived products include self-management of pain, mental health disorders, symptoms related to substance use disorders, and/or to increase energy. In the United States, kratom products have varying alkaloid content, potencies, and marketing profiles. There is little regulatory oversight over kratom, as it is currently not approved as a dietary supplement by the Food and Drug Administration. This results in substantial variability in labeling of kratom products and the product information provided to consumers. METHODS: In January 2023, we evaluated the American Kratom Association's Good Manufacturing Practices (GMP) qualified vendors' websites (n = 42) using the well-established and validated DISCERN instrument to examine the quality of health information provided to consumers. DISCERN contains 15 five-point Likert-scale questions on specific criteria, with the highest possible score being 75, indicating that all the DISCERN criteria have been fulfilled by the website (i.e., the highest quality information is provided to consumers). RESULTS: The mean DISCERN score for all evaluated online kratom vendors was 32.72 (SD = 6.69; score range 18.00-43.76). Overall, vendors scored higher on DISCERN questions assessing the website's reliability, as vendors typically provided clear information for consumers about product availability, purchasing, shipping, etc. On average, vendors scored poorly on the DISCERN section pertaining to the quality of the health information provided. Information on kratom's potential risks and benefits was particularly insufficient. CONCLUSIONS: Consumers require high quality information in order to make informed decisions concerning use, which entails disclosure of known risks and potential benefits. The online kratom vendors evaluated in this study should consider enhancing the quality of health information provided, especially information regarding kratom's risks and benefits. Further, consumers should be made aware of current knowledge gaps related to kratom's effects. Clinicians must also be aware of the lack of evidence-based information available to their patients who use kratom or are interested in using kratom products, in order to facilitate educational discussions with them.