Novel Therapeutic and Program-Based Approaches to Opioid Use Disorders.

Opioid use disorder continues to drive overdose deaths in many countries, including the United States. Illicit fentanyl and its analogues have emerged as key contributors to the complications and mortality associated with opioid use disorder. Medications for opioid use disorder treatment, such as methadone and buprenorphine, are safe and substantially reduce opioid use, infectious complications, and mortality risk, but remain underutilized. Polysubstance use and emerging substances such as xylazine and designer benzodiazepines create additional treatment challenges. Recent clinical and policy innovations in treatment delivery, including telemedicine, bridge clinics, and expanded models for accessing methadone have the potential to increase access to life-saving care for people living with opioid use disorder.

The effectiveness of moderating harmful online content.

In 2022, the European Union introduced the Digital Services Act (DSA), a new legislation to report and moderate harmful content from online social networks. Trusted flaggers are mandated to identify harmful content, which platforms must remove within a set delay (currently 24 h). Here, we analyze the likely effectiveness of EU-mandated mechanisms for regulating highly viral online content with short half-lives. We deploy self-exciting point processes to determine the relationship between the regulated moderation delay and the likely harm reduction achieved. We find that harm reduction is achievable for the most harmful content, even for fast-paced platforms such as Twitter. Our method estimates moderation effectiveness for a given platform and provides a rule of thumb for selecting content for investigation and flagging, managing flaggers' workload.

Distribution of rapid HCV antibody self-test kits via needle/syringe dispensing machines: Implementation and evaluation of the Vend-C pilot study in Melbourne, Australia.

Recent guidance from the World Health Organization strongly recommended hepatitis C virus (HCV) self-testing. We implemented the Vend-C pilot study to explore the effectiveness and feasibility of distributing rapid HCV antibody self-test kits to people who inject drugs via needle/syringe dispensing machines (SDMs). Over a 51-day study period between August and September 2022, we distributed HCV antibody self-test kits via two SDMs. During the study period, 63 self-test kits were dispensed, averaging 1.2 self-test kits per day. Our access methods for evaluation questionnaires failed to attract participants (n = 4). We implemented the Vend-C pilot study in direct response to recent WHO recommendations. While self-test kits were effectively distributed from the two SDMs, our evaluation methodology failed. Consequently, we cannot determine the success of linkage to care. Even so, with HCV treatment numbers dropping in Australia, innovative engagement solutions are needed, and considering the number of self-test kits provided in our pilot, the model could have an important future place in HCV elimination efforts.

Multilevel Factors Impacting Substance Use Treatment Access, Engagement, and Racial Equity Among Opioid Overdose Survivors in Boston, MA.

BACKGROUND: There are well-documented racial/ethnic inequities in drug-related overdoses and access to evidence-based opioid use services nationally and in Boston, MA. OBJECTIVE: To qualitatively explore the drivers of racial/ethnic inequities in access to opioid use disorder treatment and services in Boston. DESIGN: Semi-structured qualitative interviews. PARTICIPANTS: Using purposive sampling, researchers recruited 59 opioid overdose survivors in Boston who self-identified as Black, Hispanic or Latino/a/x, and/or White. APPROACH: Interviewers administered a socio-demographic and drug use survey, and used a semi-structured interview guide to explore experiences with and perspectives on substance use treatment and services. KEY RESULTS: Participants' racial/ethnic identities were distributed across three subgroups: non-Hispanic Black (n = 18; 31%), non-Hispanic White (n = 18; 31%), and Latino/a/x (n = 23; 39%). Qualitative analysis identified multiple themes that were organized into four social-ecological levels after analysis. At the individual level, some participants emphasized the importance of personal responsibility and individual motivation in determining access to services. Participants expressed a range of perspectives about using medication for opioid use disorder treatment; Black and Latino/a/x participants were more likely than White participants to have critical perspectives. At the interpersonal level, experiences of bias, stigma, and racism from staff in healthcare and treatment settings were common. At the program/process level, participants described challenges connecting to services following overdose and barriers within specific programs, with Black and Latino/a/x participants experiencing particular gaps. At the systems level, the limited availability of housing, employment, and mental health care negatively impacted treatment access and engagement. CONCLUSION: A racism lens was used during data interpretation to apply the themes at a broader population level. Through this lens, the identified barriers can be understood to have a disproportionate impact on people of color. Findings call for programmatic and policy solutions that address racism, break down stigma, and ensure equitable access to evidence-based services and social supports.

"It's Like A Partnership": Exploring the Primary Care Experiences and Patient-Defined Goals of People Who Use Drugs.

BACKGROUND: Primary care is an important yet underutilized resource in addressing the overdose crisis. Previous studies have identified important aspects of primary care for people who use drugs (PWUD) and have found patient involvement in healthcare decisions and goal-setting to be especially critical. However, there has been limited research describing the primary care goals of PWUD. In harm reduction settings, where it is imperative that PWUD set their own goals, this research gap becomes especially relevant. OBJECTIVE: To explore how PWUD navigate primary care with a focus on understanding their primary care goals. DESIGN: A qualitative study using semi-structured interviews. PARTICIPANTS: PWUD currently engaged in primary care at the Respectful and Equitable Access to Comprehensive Healthcare (REACH) Program, a harm reduction-based primary care program in New York City. APPROACH: Between June 2022 and August 2022, we conducted 17 semi-structured interviews. Informed by phenomenology, transcripts were coded using both inductive and deductive codes and themes were developed using thematic analysis approaches. KEY RESULTS: Phenomenological analysis identified four core components that, together, created an experience that participants described as "a partnership" between patient and provider: (1) patient-provider collaboration around patient-defined healthcare goals; (2) support provided by harm reduction-based approaches to primary care anchored in incrementalism and flexibility; (3) care teams' ability to address healthcare system fragmentation; and (4) the creation of social connections through primary care. This holistic partnership fostered positive primary care experiences and supported participants' self-defined care goals, thereby facilitating meaningful care outcomes. CONCLUSIONS: To best meet the primary care goals of PWUD, these findings underscore the importance of primary care providers and programs facilitating such partnerships through organizational-level support anchored in harm reduction. Future research should explore how these experiences in primary care affect patient health outcomes, ultimately shaping best practices in the provision of high-quality primary care for PWUD.

Assessing evidence supporting cannabis harm reduction practices for adolescents at clinical high-risk for psychosis: a review and clinical implementation tool.

Cannabis use is consistently associated with both increased incidence of frank psychotic disorders and acute exacerbations of psychotic symptoms in healthy individuals and people with psychosis spectrum disorders. Although there is uncertainty around causality, cannabis use may be one of a few modifiable risk factors for conversion to psychotic disorders in individuals with Clinical High Risk for Psychosis (CHR-P) syndromes, characterized by functionally impairing and distressing subthreshold psychotic symptoms. To date, few recommendations beyond abstinence to reduce adverse psychiatric events associated with cannabis use have been made. This narrative review synthesizes existing scientific literature on cannabis' acute psychotomimetic effects and epidemiological associations with psychotic disorders in both CHR-P and healthy individuals to bridge the gap between scientific knowledge and practical mental health intervention. There is compelling evidence for cannabis acutely exacerbating psychotic symptoms in CHR-P, but its impact on conversion to psychotic disorder is unclear. Current evidence supports a harm reduction approach in reducing frequency of acute psychotic-like experiences, though whether such interventions decrease CHR-P individuals' risk of conversion to psychotic disorder remains unknown. Specific recommendations include reducing frequency of use, lowering delta-9-tetrahydrocannabinol content in favor of cannabidiol-only products, avoiding products with inconsistent potency like edibles, enhancing patient-provider communication about cannabis use and psychotic-like experiences, and utilizing a collaborative and individualized therapeutic approach. Despite uncertainty surrounding cannabis' causal association with psychotic disorders, cautious attempts to reduce acute psychosis risk may benefit CHR-P individuals uninterested in abstinence. Further research is needed to clarify practices associated with minimization of cannabis-related psychosis risk.

Key issues surrounding the health impacts of electronic nicotine delivery systems (ENDS) and other sources of nicotine.

Answer questions and earn CME/CNE Over the last decade, the use of electronic nicotine delivery systems (ENDS), including the electronic cigarette or e-cigarette, has grown rapidly. More youth now use ENDS than any tobacco product. This extensive research review shows that there are scientifically sound, sometimes competing arguments about ENDS that are not immediately and/or completely resolvable. However, the preponderance of the scientific evidence to date suggests that current-generation ENDS products are demonstrably less harmful than combustible tobacco products such as conventional cigarettes in several key ways, including by generating far lower levels of carcinogens and other toxic compounds than combustible products or those that contain tobacco. To place ENDS in context, the authors begin by reviewing the trends in use of major nicotine-containing products. Because nicotine is the common core-and highly addictive-constituent across all tobacco products, its toxicology is examined. With its long history as the only nicotine product widely accepted as being relatively safe, nicotine-replacement therapy (NRT) is also examined. A section is also included that examines snus, the most debated potential harm-reduction product before ENDS. Between discussions of NRT and snus, ENDS are extensively examined: what they are, knowledge about their level of "harm," their relationship to smoking cessation, the so-called gateway effect, and dual use/poly-use. CA Cancer J Clin 2017;67:449-471. © 2017 American Cancer Society.

Impact of switching from cigarette smoking to tobacco heating system use on biomarkers of potential harm in a randomized trial.

BACKGROUND: Smoking cessation reduces the risk of developing smoking-related diseases. Although smoking prevalence has declined, many continue smoking cigarettes. Switching completely to smoke-free alternatives like the Tobacco Heating System (THS) 2.2-a heated tobacco product for which there is evidence demonstrating significantly reduced formation and exposure to harmful chemicals compared to cigarettes-has the potential to reduce the harm caused by continuing to smoke cigarettes. METHODS: We conducted a 6-month clinical study (NCT02396381) with a 6-month extension (NCT02649556), initially randomizing 984 adult smokers to continue smoking or switch to THS (non-mentholated), of which 672 continued into the extension study. Endpoints were evaluated at baseline and at 3, 6, and 12 months. We longitudinally assessed biomarkers of potential harm (BoPHs) known to be reversible upon smoking cessation as indicators of pathways involved in the pathogenesis of cardiovascular or respiratory diseases and carcinogenicity. The need to cough and safety profile were also assessed. Impact on eight key BoPHs was used as a proxy to evaluate harm reduction potential. RESULTS: At 12 months, comparison of BoPH levels between the predominant THS use and cigarette smoking groups showed a positive effect in favor of switching, partially or in full, to THS. CONCLUSION: These results provide additional evidence of the harm reduction potential of THS for smokers who would otherwise continue smoking, but they need to be verified in long-term confirmatory studies. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT0264955. Date of registration: January 7, 2016 https://clinicaltrials.gov/ct2/show/NCT02649556.

Exploring group differences in the response to a sexual risk reduction intervention to prevent hepatitis C virus reinfection in HIV-infected MSM: a mixed-methods study.

To prevent hepatitis C virus (HCV) reinfection, within the Swiss HCVree Trial, a preventive risk reduction intervention was implemented alongside curative treatment. Formative qualitative research identified three response patterns to the intervention. This mixed-methods study's aim was to cross-validate group differences in (a) the content of sexual risk reduction goals set during intervention and (b) the extent of their behavioural change in condomless anal intercourse with non-steady partners (nsCAI), sexualised and intravenous drug use at start and six-month post-intervention. Qualitative thematic analysis was used to summarise goal setting domains. Quantitative descriptive analysis was used to evaluate group differences based on assumptions of the group descriptions. Results largely confirmed assumptions on inter-group response differences in goal setting and behaviour: as expected group 1 Avoid risks showed the lowest HCV risk profile with changes in nsCAI. Group 2 Minimize-risks and Group 3 Accept-risks showed unchanged nsCAI. Group 3 had the highest HCV risk profile. Differences in their goal preferences (1: condom use; 2 reduction blood exposure; 3 safer dating) highlight diversity in attitudes to behavioural change. Our results improve understanding of variability in intervention responses such as changes in attitudes and behaviour. This provides evidence for intervention tailoring and outcome measurement.

Using an intersectionality lens to explore barriers and enablers to hepatitis C point-of-care testing: a qualitative study among people who inject drugs and service providers.

BACKGROUND: Hepatitis C virus (HCV) infection is a significant global health burden, particularly among people who inject drugs. Rapid point-of-care HCV testing has emerged as a promising approach to improve HCV detection and linkage to care in harm reduction organizations such as needle and syringe programs. The objective of this study was to use an intersectionality lens to explore the barriers and enablers to point-of-care HCV testing in a needle and syringe program. METHODS: A qualitative study was conducted using semi-structured interviews with clients (people who inject drugs) and service providers in a large community organization focused on the prevention of sexually transmitted and blood borne infections and harm reduction in Montreal, Canada. An intersectionality lens was used alongside the Theoretical Domains Framework to guide the formulation of research questions as well as data collection, analysis, and interpretation. RESULTS: We interviewed 27 participants (15 clients, 12 providers). For clients, four themes emerged: (1) understanding and perceptions of HCV testing, (2) the role of an accessible and inclusive environment, (3) the interplay of emotions and motivations in decision-making, and (4) the impact of intersectional stigma related to HCV, behaviors, and identities. For providers, five themes emerged: (1) knowledge, skills, and confidence for HCV testing, (2) professional roles and their intersection with identity and lived experience, (3) resources and integration of services, (4) social and emotional factors, and (5) behavioral regulation and incentives for HCV testing. Intersectional stigma amplified access, emotional and informational barriers to HCV care for clients. In contrast, identity and lived experience acted as powerful enablers for providers in the provision of HCV care. CONCLUSION: The application of an intersectionality lens provides a nuanced understanding of multilevel barriers and enablers to point-of-care HCV testing. Findings underscore the need for tailored strategies that address stigma, improve provider roles and communication, and foster an inclusive environment for equitable HCV care. Using an intersectionality lens in implementation research can offer valuable insights, guiding the design of equity-focused implementation strategies.

Neighborhood and Individual Disparities in Community-Based Naloxone Access for Opioid Overdose Prevention.

Improving access to naloxone for laypersons is a cornerstone of the US strategy to reduce opioid overdose deaths. This study evaluated change in distance to opioid overdose prevention programs (OOPPs) providing walk-in naloxone across two time points. We also explored individual and neighborhood disparities in distance to OOPPs, associations between 2020 OOPP locations and 2018 overdoses, and associations between OOPPs and neighborhood fatal overdose rates. Using fatal opioid overdose locations in 2018 (n = 1167) and 2020 (n = 2045) in New York City, we mapped OOPP locations and fatal overdose locations to visualize areas of unmet naloxone need. We used logistic regression to assess individual (age, sex, race/ethnicity) and neighborhood correlates of odds of an overdose occurring within walking distance (≤ 0.5 miles or 0.8 km) of an OOPP and negative binomial regression to assess the relationship between census tract-level OOPP counts and overdose rates. Distance to OOPPs significantly improved over time, with average distance decreasing by 1.7 miles (2.7 km) (p < 0.001). OOPPs were more likely to be located in neighborhoods with higher poverty in both years and in closer proximity to Latinos in 2020-suggesting improved access for Latinos and in higher poverty neighborhoods. OOPP locations in 2020 were significantly positively associated with overdose locations in 2018. OOPPs were not well-situated in neighborhoods with elevated overdose rates in 2018 but were better situated in 2020, controlling for other neighborhood variables. Community lay naloxone access through OOPPs improved over time and could have promising effects for improved overdose rates in the future.

Characterizing Use of Supervised Consumption Services among Street-involved Youth and Young Adults in the Context of an Overdose Crisis.

In response to an increase in overdose deaths, there was a rapid scale-up of supervised consumption services (SCS), including federally sanctioned SCS and low-barrier SCS known as overdose prevention sites (OPS), in Vancouver, Canada, beginning in December 2016. However, little is known about the use of such services among adolescents and young adults (AYA) in this context. We therefore sought to characterize factors associated with the use of federally sanctioned SCS and OPS among street-involved AYA who inject drugs in Vancouver during an overdose crisis. From December 2016 to March 2020, data were collected from a prospective cohort of street-involved AYA aged 14 to 26 at baseline. Using multivariable generalized estimating equation analyses, we identified factors associated with recent use of federally sanctioned SCS and OPS, respectively. Among 298 AYA who inject drugs, 172 (57.8%) and 149 (50.0%) reported using federally sanctioned SCS and OPS during the study period, respectively. In multivariable analyses, public injecting, negative police interactions, and residing or spending time ≥ weekly in the Downtown Eastside neighborhood were all positively associated with the use of federally sanctioned SCS and OPS, respectively. Additionally, ≥ daily unregulated opioid use and residential eviction were positively associated with federally sanctioned SCS use, while requiring help injecting was inversely associated. Self-identified female or non-binary gender was also positively associated with OPS use (all p < 0.05). Both federally sanctioned SCS and OPS successfully engaged AYA at heightened risk of adverse health outcomes. However, the lack of accommodation of AYA who require manual assistance with injecting at federally sanctioned SCS may be inhibiting service engagement.

Using pod based e-cigarettes and nicotine pouches to reduce harm for adults with low socioeconomic status who smoke: A pilot randomized controlled trial.

INTRODUCTION: Alternative Nicotine Delivery Systems (ANDS) such as e-cigarettes (EC) and oral nicotine pouches (ONP) may facilitate the substitution of smoking for those unwilling to quit. This pilot study assesses the harm reduction potential of EC and ONP among smokers with low socioeconomic status (SES). METHODS: Adults who smoked daily in the past 6 months, had a household income < 250% federal poverty level and had no intention of quitting smoking in the next 30 days were randomized 2:2:1 to 8 Weeks of 5% nicotine EC; 4mg ONP or assessment-only control (CC). The primary outcome was a within-group change in cigarettes per day (CPD) from Baseline to Week 8. RESULTS: 45 individuals were randomized (EC: N=18; ONP: N=18; CC: N=9). Analyses included 33 participants who completed the Week 8 visit. Mean age was 50.2 years (SD:10.7) and average CPD at baseline was 13.9 (SD: 10.1). For those randomized to EC, average CPD decreased from 14.7 (95%CI: 10.3; 19.1) at Baseline to 2.9 (95%CI: 0.09; 5.79) at Week 8 (p-value <0.001). For those randomized to ONP, average CPD decreased from 15.0 (95%CI: 5.02; 24.93) to 8.3 (95%CI: 1.34; 15.18) by Week 8 (p-value =0.01). In the EC and ONP groups, respectively, 4 (28.6%) and 1 (8.3%) participant fully switched from smoking to the ANDS product by Week 8. CONCLUSIONS: Individuals with low SES who smoke had lower CPD after switching to EC or ONP. These findings show the potential of ANDS in helping smokers switch to less harmful devices. IMPLICATIONS: This study provides novel evidence that e-cigarettes and nicotine pouches can be a harm reduction tool for individuals with lower SES who smoke and are not willing to quit smoking, contributing to reducing tobacco-related disparities in this population.

Brief intervention for chronic liver disease patients with alcohol use disorder in a hepatology outpatient unit: Effects and limitations.

AIM: It is not uncommon to encounter outpatients in the hepatology department with harmful alcohol habits. When treating such chronic liver disease (CLD) patients, an adequate intervention method for harm reduction of alcohol use, such as brief intervention (BI) or BI and nalmefene, should be considered. This study aimed to elucidate the clinical effectiveness of BI for CLD patients affected by harmful alcohol use. METHODS: From June 2021 to 2023, 123 Japanese CLD outpatients (hepatitis B virus : hepatitis C virus : alcoholic liver disease : others = 32:18:42:31) with an Alcohol Use Disorders Identification Test (AUDIT) score of ≥8 at the initial interview and a repeat interview with AUDIT 9 months later were enrolled. Clinical features related to patient behavior following the initial AUDIT interview were retrospectively evaluated, and compared between patients without and with BI treatment. RESULTS: For the non-BI and BI groups, baseline AUDIT score (median 10 [interquartile range (IQR) 9-13] vs. 12 [IQR 10-17], p = 0.016) and relative change in AUDIT score (median 0 [IQR -3 to 2] vs. -3 [IQR -7 to 0], p < 0.01) showed significant differences, whereas there was no significant difference between the groups for AUDIT score at the time of the second interview (p = 0.156). Following BI, significant improvements were observed for items 1, 2, 3, 4, 5, 8, and 10 of AUDIT (each p < 0.05). CONCLUSION: Patients with an alcohol use disorder as well as those with alcohol dependency who received BI showed a significant decline in AUDIT score, although the score of the follow-up AUDIT indicated continued alcohol use disorder. In addition to BI, medication with nalmefene should be considered, based on individual factors.

A new innovative method to measure the cost of war: future with fewer conflicts via harm reduction approaches.

BACKGROUND: The destruction of World War I (WWI) and World War II (WWII) changed the world forever. In this analysis, the economic costs of WWI and WWII are considered via a harm reduction approach to highlight the cost of war via the mortality of military personnel. The harm reduction philosophy and homeostasis of a biological cell are utilized as a pragmatic approach and analogy to give a greater context to the findings, despite the omission of civilian casualties and military disabilities. METHODS: Tangible (e.g., loss of wages, productivity, and contributions) and intangible (e.g., quality of life) costs are estimated based on the value of each military personnel derived from secondary data and a mathematical model. This is the first study to estimate the cost of war based on soldier's mortality during the first and second World War. RESULTS: Based on the tangible value, the WWI and WWII cost for the military personnel was US$43.204 billion ($13 billion ≤ α ≤ $97 billion) and US$540.112 billion ($44 billion ≤ α ≤ $1 trillion). When the intangible cost is considered, it is estimated that the WWI cost was beyond US$124 trillion ($43 trillion ≤ ß ≤ $160 trillion), and the WWII cost was above US$328 trillion ($115 trillion ≤ ß ≤ $424 trillion). The sensitivity analyses conducted for WWI and WWII demonstrate different ranges based on tangible and intangible values. CONCLUSIONS: In the current climate of increasing hostilities, inequalities, global warming, and an ever-changing world, economic prosperities are directly linked to peace, stability, and security. Therefore, any future decisions for military conflicts need to increasingly consider harm reduction approaches by considering the cost of life and potential disabilities for each nations' soldiers, sailors, and pilots.

"Once I take that one bite": the consideration of harm reduction as a strategy to support dietary change for patients with diabetes.

BACKGROUND: Despite well-established guidelines to treat diabetes, many people with diabetes struggle to manage their disease. For many, this struggle is related to challenges achieving nutrition-related lifestyle changes. We examined how people with diabetes describe barriers to maintaining a healthy diet and considered the benefits of using a harm reduction approach to assist patients to achieve nutrition-related goals. METHODS: This is a secondary analysis of 89 interviews conducted with adults who had type 1 or type 2 diabetes. Interviews were analyzed using a content analysis approach. Themes regarding food or diet were initially captured in a "food" node. Data in the food node were then sub-coded for this analysis, again using a content analysis approach. RESULTS: Participants frequently used addiction language to talk about their relationship with food, at times referring to themselves as "an addict" and describing food as "their drug." Participants perceived their unhealthy food choices either as a sign of weakness or as "cheating." They also identified food's ability to comfort them and an unwillingness to change as particular challenges to sustaining a healthier diet. CONCLUSION: Participants often described their relationship with food through an addiction lens. A harm reduction approach has been associated with positive outcomes among those with substance abuse disorder. Patient-centered communication incorporating the harm reduction model may improve the patient-clinician relationship and thus improve patient outcomes and quality-of-life while reducing health-related stigma in diabetes care. Future work should explore the effectiveness of this approach in patients with diabetes. TRIAL REGISTRATION: Registered on ClinicalTrials.gov, NCT02792777. Registration information submitted 02/06/2016, with the registration first posted on the ClinicalTrials.gov website 08/06/2016. Data collection began on 29/04/2016.

Harm reduction strategies for cannabis-related problems: a literature review and typology.

Measures that seek to minimise the health and social consequences of substance use are an integral part of national drug strategies in many European countries. Against the backdrop of a high prevalence of cannabis use in the economically advanced countries, and increasing demand for treatment for cannabis-related problems, a range of harm reduction measures have been implemented by peers, statutory bodies and third-sector organisations. Based on a systematic review of the literature, the author describes these different forms of intervention, identifies innovative strategies and presents a simple typology that can be used when exploring existing measures or seeking to develop new policies. This typology covers different kinds of legal, socio-organisational and health-related interventions. All study designs were eligible for inclusion, with the exception of case reports, non-systematic reviews, editorials and news stories. Studies had to be published between 2011 and 2022, in English, and they had to refer to Europe, the Americas, Australia or New Zealand. A two-concept search was implemented using Embase.com and a number of other databases, combined with citation searches and manual website searching to improve coverage of research reports and advocacy documents. A total of 35 documents were deemed eligible, many of which rely on qualitative research methods.

PMI-funded foundation for a smoke-free world: application of criteria to assess funding models that include financial support from the tobacco industry.

Recent changes to the leadership and the terms of tobacco industry financing of the Foundation for a Smoke-Free World (FSFW) have called for a revisiting of a paper published in 2009 where we proposed criteria and other considerations to assess possible funding models for research that include financial support from the tobacco industry. This paper reviews and attempts to apply the elements laid out in 2009 to the current state of FSFW. After discussing each criterion and consideration we conclude that, at this point in time, conducting a thorough assessment using our 2009 paper is not possible because critical details related to FSFW governance, decision-making and process have not been announced. Nonetheless, we hope this paper will remind the tobacco control community that the 2009 criteria exist and highlight the information needed and questions that might be asked of FSFW to help form judgements about this new iteration of the foundation. We further hope this will put the FSFW on notice that they need to address each of these criteria and speak publicly about their plans regarding the specific issues raised in the 2009 paper.

Analysis of FDA's Vuse market authorisation: limitations and opportunities.

This special communication provides a physicians' critique of the US Food and Drug Administration (FDA)'s decision to authorise the Vuse Solo (Vuse) Premarket Tobacco Application (PMTA). The PMTA authorisation represents the first time that FDA has authorised an Electronic Nicotine Delivery System (ENDS) for marketing in the USA. Using the FDA Decision Summary, the special communication identifies significant unanswered public health and scientific questions that prevent the authors from reaching FDA's conclusion that Vuse meets the Appropriate for the Protection of the Public Health (APPH) standard. The authors recommend FDA suspend the market authorisation and use these questions to re-evaluate the PMTA, and to prospectively monitor whether Vuse meets APPH standard. The special communication advances the ENDS harm reduction conversation because it calls for national tobacco regulators to develop an epidemiological prediction of ENDS impact on the population and to expand the scope of their analysis to evaluate the impacts of ENDS on congenital birth defects, abuse liability and non-flavour drivers of youth usage. Through learning from the American experience regulating Vuse, national tobacco regulators around the globe will be better equipped to evaluate the impact of ENDS on the public health.

Switching from cigarettes to IQOS: the relative importance of IQOS-associated reward, reinforcement and abstinence relief.

INTRODUCTION: This study investigated whether IQOS, a heated tobacco product, can fully substitute for combustible cigarettes and the factors that promote substitution. METHODS: Adults who smoked cigarettes daily (N=90; 21-65 years) completed a baseline ad-lib smoking period (days 1-5), two laboratory visits (days 6-7) and a 2-week period where they were instructed to switch from smoking cigarettes to using IQOS 3.0 (days 8-21). Mixed-effect modelling estimated the changes in cigarettes per day (CPD) and the percentage of baseline CPD substituted by HeatSticks during the switch period. Predictors included IQOS-associated subjective reward, relative reinforcing value, craving relief and withdrawal relief. RESULTS: Participants reduced their CPD to about 30% of their baseline smoking rate by the end of the 14-day switch period (p<0001). A lower versus higher reinforcing value of smoking relative to IQOS (RRV; break point <5 vs ≥5) predicted greater reductions in CPD (ß=-1.31 (95% CI -2.35 to -0.27) p=0.013). Initially, IQOS use was 72% of the baseline smoking rate (ß=71.64 (95% CI 42.79 to 100.48) p<0.0001) and climbed by 0.8% per day (ß=0.82 (95% CI 0.01 to 1.64) p=0.05), for an average substitution rate of 83%. The subjective reward of IQOS was the only predictor of a higher substitution rate (ß=4.26 (95% CI 1.03 to 7.50) p=0.01). CONCLUSIONS: IQOS fully substituted for cigarettes in ~20% of people who were not immediately interested in quitting smoking while the remainder significantly reduced their smoking. Positive reinforcing effects of IQOS foster use and the transition away from combustible cigarettes. TRIAL REGISTRATION NUMBER: NCT05076708.