The effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation in people with mental illnesses and addictions: study protocol for a randomised-controlled trial.

BACKGROUND: Smoking rates are higher in New Zealand (NZ) adults with mental illnesses and alcohol and other drug (AOD) addictions, compared to the overall population. Quit attempts using "gold standard" smoking cessation treatments often fail in people with these conditions, so more flexible treatment regimens that adapt to a person's responsiveness to treatment are worth investigating. The STATUS trial aims to evaluate the effectiveness and safety of combining varenicline with nicotine e-cigarettes for smoking cessation among varenicline non-responders in treatment for mental health illnesses and/or AOD addictions. METHODS: This is a pragmatic two-arm, open-label, randomised trial. Participants will be daily smokers using mental health and/or addiction services in Auckland, aged ≥18 years, motivated to quit smoking, and eligible to access varenicline through the NZ special authority process. After 2 weeks of using varenicline plus behavioural support, participants who have not reduced their daily smoking by ≥50% will be randomised (1:1) to either 10 weeks of continued varenicline use or 10 weeks of varenicline plus an 18 mg/mL nicotine e-cigarette. All participants will receive weekly withdrawal-orientated behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically-verified (exhaled carbon monoxide) continuous abstinence at 24 weeks post-randomisation. Secondary outcomes, measured at six, 12 and 24 weeks post-randomisation include: self-reported continuous abstinence, 7-day point prevalence abstinence, smoking reduction, time to relapse, cross-over, use of other smoking cessation support, serious adverse events, treatment adherence, compliance, acceptability, dual use, continuation of treatment use, mental illness symptoms and AOD use, health-related quality of life, and cost-analysis. A sample size of 338 will confer 80% power (p = 0.05) to detect a 15% absolute difference between the varenicline alone and varenicline plus e-cigarette groups. DISCUSSION: People with mental illness and/or AOD addictions are just as motivated as others to quit smoking, but are less likely to succeed. Adapting smoking cessation medication after a lack of responsiveness in the first 2 weeks of initial treatment in this priority population by adding a nicotine e-cigarette may be one way to increase long-term quit rates. TRIAL REGISTRATION: Australian NZ Clinical Trial Registry: ACTRN12616001355460 (29 September 2016).

World addiction medicine reports: formation of the International Society of Addiction Medicine Global Expert Network (ISAM-GEN) and its global surveys.

Addiction medicine is a dynamic field that encompasses clinical practice and research in the context of societal, economic, and cultural factors at the local, national, regional, and global levels. This field has evolved profoundly during the past decades in terms of scopes and activities with the contribution of addiction medicine scientists and professionals globally. The dynamic nature of drug addiction at the global level has resulted in a crucial need for developing an international collaborative network of addiction societies, treatment programs and experts to monitor emerging national, regional, and global concerns. This protocol paper presents methodological details of running longitudinal surveys at national, regional, and global levels through the Global Expert Network of the International Society of Addiction Medicine (ISAM-GEN). The initial formation of the network with a recruitment phase and a round of snowball sampling provided 354 experts from 78 countries across the globe. In addition, 43 national/regional addiction societies/associations are also included in the database. The surveys will be developed by global experts in addiction medicine on treatment services, service coverage, co-occurring disorders, treatment standards and barriers, emerging addictions and/or dynamic changes in treatment needs worldwide. Survey participants in categories of (1) addiction societies/associations, (2) addiction treatment programs, (3) addiction experts/clinicians and (4) related stakeholders will respond to these global longitudinal surveys. The results will be analyzed and cross-examined with available data and peer-reviewed for publication.

Developing a Theoretically Informed Implementation Model for Telemedicine-Delivered Medication for Opioid Use Disorder: Qualitative Study With Key Informants.

BACKGROUND: Telemedicine-delivered medication for opioid use disorder (TMOUD) has become more prevalent during the COVID-19 pandemic, particularly in North America. This is considered a positive development as TMOUD has the potential to increase access to evidence-based treatment for a population heavily affected by the opioid crisis and consequent rising mortality and morbidity rates in relation to opioid use disorder. Despite the increase in the use of TMOUD, there are no established service- and process-focused models to guide the implementation of this intervention. OBJECTIVE: This study aims to develop a process- and service-focused implementation model in collaboration with key stakeholders and bring together peer-reviewed literature, practice-based knowledge, and expert opinions. METHODS: The simple rules for evidence translation in complex systems framework was applied to guide the development of a 6-step qualitative study. The steps were definition of the scope and objectives of the model, identification of evidence, stakeholder engagement, draft model development, key informant consultation, and final model specification. RESULTS: The final specification for the TMOUD implementation model incorporated key strategic priorities, service delivery prerequisites, service design elements, stakeholder identification and engagement, key process domains, and iterative cycles of evaluation and improvement. CONCLUSIONS: Through stakeholder engagement and key informant consultation, we produced a process- and service-focused TMOUD implementation model. The model is modifiable to different contexts and settings while also in keeping with the current evidence base and national and international standards of high-quality opioid use disorder care.

Key implementation factors in telemedicine-delivered medications for opioid use disorder: a scoping review informed by normalisation process theory.

Telemedicine could improve access to medications for opioid use disorder (MOUD). Telemedicine-delivered MOUD (TMOUD) has expanded substantially in response to the restrictions imposed by the COVID-19 pandemic on in-person clinical contact, yet this expansion has not happened consistently across all health systems and countries. This Review aims to understand key factors in TMOUD implementation that might explain variations in uptake. We did a scoping review using three English language databases for articles reporting on the implementation of TMOUD services. 57 peer-reviewed articles were identified, subjected to open coding and thematic analysis, and further interpreted through normalisation process theory (NPT). NPT was originally used to evaluate telehealth innovations and has been applied extensively to describe, assess, and develop the implementation potential of a broad range of complex health-care interventions. By categorising our findings according to the four core NPT constructs of coherence, cognitive participation, collective action, and reflexive monitoring, we aim to rationalise the current evidence base to show the workability of TMOUD in practice. We find that variations in TMOUD models in practice depend on organisations' attitudes towards risk, clinicians' tensions around giving up control over standard practices, organisation-level support in overcoming operational and technological challenges, and evaluation methods that might neglect a potential widening of the digital divide.

Challenges of virtual talking therapies for substance misuse in New Zealand during the COVID-19 pandemic: an opinion piece.

The COVID-19 pandemic requires us to rethink how virtual approaches might work for people who use alcohol and other drugs. Are virtual clinics only suitable for clients with whom clinicians have already formed a therapeutic relationship? How well would virtual clinics work for new clients presenting to services, for clients in acute distress, and for those with complex problems? Addressing the sustained change required to maintain substance-free lives or a safe substance-use life requires robust psychotherapeutic approaches, which have traditionally been delivered through physical contact, whether they are one-to-one or group-based interventions. The challenge during this time of the COVID-19 pandemic is to deliver effective talking therapies while avoiding physical contact. How then should services continue to offer counselling and support in such an environment? How can we learn from the COVID-19 situation to deliver treatment to individuals who may have difficulties attending traditional clinic-based care, such as those in more rural areas with transport difficulties? This article focuses on identifying practical issues and providing some solutions.

COVID-19 and Substance Use Disorders: Recommendations to a Comprehensive Healthcare Response. An International Society of Addiction Medicine Practice and Policy Interest Group Position Paper.

Coronavirus Disease 2019 (COVID-19) is escalating all over the world and has higher morbidities and mortalities in certain vulnerable populations. People Who Use Drugs (PWUD) are a marginalized and stigmatized group with weaker immunity responses, vulnerability to stress, poor health conditions, high-risk behaviors, and lower access to health care services. These conditions put them at a higher risk of COVID-19 infection and its complications. In this paper, an international group of experts on addiction medicine, infectious diseases, and disaster psychiatry explore the possible raised concerns in this issue and provide recommendations to manage the comorbidity of COVID-19 and Substance Use Disorder (SUD).