Pilot Randomized Controlled Trial of a Novel Smoking Cessation App Designed for Individuals With Co-Occurring Tobacco Use Disorder and Serious Mental Illness.

INTRODUCTION: High rates of tobacco use among people with serious mental illness (SMI), along with their unique needs, suggest the importance of developing tailored smoking cessation interventions for this group. Previous early-phase work empirically validated the design and content of Learn to Quit, a theory-based app designed for this population. METHODS: In a pilot randomized controlled trial, we compared the feasibility, acceptability, and preliminary efficacy of Learn to Quit versus QuitGuide, an app designed for the general population. All participants received nicotine replacement therapy and technical assistance. Daily smokers with SMI (N = 62) participated in the trial with outcomes assessed at weeks 4, 8, 12, and 16. RESULTS: Compared to QuitGuide, Learn to Quit participants had similar number of days of app use (34 vs. 32, p = .754), but larger number of app interactions (335 vs. 205; p = .001), longer durations of app use (4.24 hrs. vs. 2.14 hrs; p = .044), and higher usability scores (85 vs. 79, p = .046). At week 16, Learn to Quit led to greater reductions in cigarettes per day (12.3 vs. 5.9 for QuitGuide; p = 0.10). Thirty-day point prevalence abstinence was verified in 12% of Learn to Quit participants versus 3% of QuitGuide participants (odds ratio = 3.86, confidence interval = 0.41 to 36, p = .239). Changes in psychiatric symptoms and adverse events were not clinically significant between conditions. CONCLUSIONS: This pilot trial provides strong evidence of Learn to Quit's usability, feasibility, and safety. Preliminary evidence suggests the app may be efficacious. A randomized controlled efficacy trial is needed to test the app in a larger sample of smokers with SMI. IMPLICATIONS: This study suggests that the Learn to Quit app is a feasible approach to deliver smoking cessation treatment in patients with co-occurring tobacco use disorder and SMI. This means that, if found efficacious, this technology could be used to deploy smoking cessation treatment to larger segments of this population, hence improving public health. Therefore, a randomized controlled trial should be conducted to examine the efficacy of this digital intervention.

Protocol for a randomised trial of a self-directed digital pain management intervention (Empowered Relief) tailored to adults with chronic pain and prescription opioid misuse/disorder: the MOBILE Relief study.

INTRODUCTION: Chronic pain increases the risk of prescription opioid misuse or opioid use disorder (OUD). Non-pharmacological treatments are needed to dually address pain and opioid risks. The purpose of the Mobile and Online-Based Interventions to Lessen Pain (MOBILE Relief) study is to compare a one-session, video-based, on-demand digital pain relief skills intervention for chronic pain ('Empowered Relief' (ER); tailored to people at risk for opioid misuse or with opioid misuse/OUD) to a one-session digital health education intervention ('Living Better'; no pain management skills). METHODS AND ANALYSIS: MOBILE Relief is an international online randomised controlled clinical trial. Study participants are adults with chronic, non-cancer pain (≥6 months) with daily pain intensity ≥3/10, taking ≥10 morphine equivalent daily dose and score ≥6 on the Current Opioid Misuse Measure. Participants are recruited through clinician referrals and clinic advertisements. Study procedures include electronic eligibility screening, informed consent, automated 1:1 randomisation to the treatment group, baseline measures, receipt of assigned digital treatment and six post-treatment surveys spanning 3 months. Study staff will call participants at baseline and 1-month and 3 months post-treatment to verify the opioid prescription. The main statistical analyses will include analysis of covariance and mixed effects model for repeated measurements regression. MAIN OUTCOMES: Primary outcomes are self-reported pain catastrophising, pain intensity, pain interference, opioid craving and opioid misuse at 1-month and 3 months post-treatment. We will determine the feasibility of ER (≥50% participant engagement, ≥70% treatment appraisal ratings). We hypothesise the ER group will be superior to the Living Better group in the reduction of multiprimary pain outcomes at 1-month post-treatment and opioid outcomes at 1-month and 3 months post-treatment. ETHICS AND DISSEMINATION: The study protocol was approved by the Stanford University School of Medicine Institutional Review Board (IRB 61643). We will publish results in peer-reviewed journals; National Institute of Drug Abuse (funder) and MOBILE Relief participants will receive result summaries. TRIAL REGISTRATION NUMBER: NCT05152134.

"You Almost Feel Out of Touch [For Saying] 'Oh, and by the way, Stop Smoking.'" A Qualitative Exploration of Provider Perspectives About Discussing Tobacco and Cannabis Use With 18-24-Year-Old Young Adults With HIV.

Background: Youth with HIV (YWH) aged 18-24 are overburdened by tobacco, with half also using cannabis recreationally. Increasing tobacco cessation necessitates exploring providers' approaches to cessation. Methods: Grounded in social cognitive theory, we explored cognitive, socioenvironmental, and behavioral factors impacting providers' approaches to tobacco use among recreational cannabis users. Virtual interviews were conducted among healthcare providers caring for YWH in Washington (legalized cannabis), Massachusetts (legalized cannabis), and Alabama (cannabis not legal). Interviews were transcribed and analyzed via deductive and exploratory, thematic approaches using NVivo 12 Plus. Results: Twelve providers participated; 80% were subspecialist physicians. All providers (N = 12) reported discussing tobacco use; none reported discussing tobacco use in conjunction with cannabis use. Identified themes included competing demands including cannabis co-use, prioritization of social determinants of health, and need for youth-tailored tools. Conclusions: YWH disproportionately use tobacco and recreational cannabis. Optimizing clinical visits to identify opportunities to address tobacco is crucial.

Discrimination and insomnia: Examining depressive symptoms and nicotine withdrawal through a serial mediation model in a sample of smokers.

Insomnia is a common sleep disorder associated with poor health outcomes. Individuals from racially underrepresented groups as well as women tend to report more severe insomnia symptoms, and frequent experiences of discrimination have been found to drive such disparities. Smokers commonly experience sleep problems since nicotine can alter the sleep-wake cycle. Discrimination is associated with increased nicotine dependence, and such discrimination may also intensify tobacco withdrawal, specifically mood and cognitive-related aspects of withdrawal. The potential impact of discrimination on withdrawal symptoms and related mood symptoms like depression may lead to increases in insomnia symptoms. However, no studies to date have evaluated the indirect association of discrimination with insomnia severity through nicotine withdrawal and depressive symptoms. Therefore, this cross-sectional survey of n = 110 non-Hispanic Black and White current smokers (48.2 % Black, 69.1 % women) investigated these associations through a serial mediation model. Controlling for race, gender, nicotine dependence levels, and income, multivariate analyses supported a significant indirect effect of discrimination on insomnia severity through depressive symptoms. Analyses supported the hypothesized serial mediation model whereby discrimination is positively associated with depressive symptoms, which in turn are linked to more severe nicotine withdrawal, leading to greater insomnia severity. Smokers encountering frequent experiences of discrimination might be at increased risk of suffering insomnia as a result of their increased depressive and withdrawal symptoms. Future work is necessary to understand the role of depressive symptoms in these associations as well as possible implications for smoking relapse and success of smoking cessation programs.

An Open-label Pilot Study of NicoBloc as a Novel Smoking Cessation Intervention.

INTRODUCTION: NicoBloc is a viscous fluid applied to the cigarette filter designed to block tar and nicotine. This novel and understudied smoking cessation device presents a nonpharmacological means for smokers to gradually reduce nicotine and tar content while continuing to smoke their preferred brand of cigarette. This pilot study aimed to assess the feasibility, acceptability, and initial efficacy of NicoBloc as compared with nicotine replacement therapy (nicotine lozenge). METHODS: A community sample of predominately Black smokers (N = 45; 66.7% Black) were randomized to receive NicoBloc or nicotine lozenge. Both groups engaged in 4 weeks of smoking cessation therapy followed by 2 months of independent usage with monthly check-ins to assess medication adherence. The intervention lasted 12 weeks, and the study concluded with a 1-month postintervention follow-up visit (week 16). RESULTS: NicoBloc was comparable with nicotine lozenge in smoking reduction, feasibility, symptom adverse effects, and reported acceptability at week 16. Participants in the lozenge group endorsed higher treatment satisfaction ratings during the intervention and lower cigarette dependence. Adherence to NicoBloc was superior throughout the study. CONCLUSION: NicoBloc was feasible and acceptable to community smokers. NicoBloc presents a unique, nonpharmacological intervention. Future research is needed to examine whether this intervention may be most effective in subpopulations where pharmacological approaches are restricted or in combination with established pharmacological methods such as nicotine replacement therapy.

An examination of neurocognition and theory of mind as predictors of engagement with a tailored digital therapeutic in persons with serious mental illness.

There is an increasing interest in the development and implementation of digital therapeutics (apps) in individuals with serious mental illness (SMI). However, there is limited understanding of the role of neurocognition and social cognition on engagement with apps. The present study is a secondary analysis of a pilot randomized controlled trial (N = 62) comparing a tailored digital intervention to treat tobacco use disorder in individuals with SMI to a standard of care digital intervention for the general population. The purpose of this study was to examine the impact of neurocognition, social cognition, and clinical characteristics on indices of app engagement in users of the tailored app compared to users of the standard of care app. Correlational analyses demonstrated that individuals with low levels of neurocognition and social cognition engaged more often and for longer duration with the tailored app compared to the standard of care app. In a series of multilevel zero-inflated negative binomial models, assignment to the tailored app remained the most robust predictor of app interactions (Risk Ratio [RR] = 1.72; p < .01), duration of app use (RR = 6.47; p < .01), and average length of interaction (RR = 2.70; p < .01), after adjusting for key demographic and clinical characteristics, and two measures of cognition. This is one of the first studies to demonstrate that digital therapeutics can be designed to mitigate the impact of neurocognition and social cognition on device engagement in SMI populations. Recommendations are made to advance the use of new analytic models to uncover patterns of engagement with digital therapeutics.

Review of Popularity and Quality Standards of Opioid-Related Smartphone Apps.

PURPOSE OF REVIEW: Opioid misuse, addiction, and related harm is a global crisis that affects public health and social and economic welfare. Many of the strategies being used to combat the opioid crisis could benefit from improved access and dissemination, such as that afforded by smartphone apps. The goal of this study was to characterize the purpose, audience, quality and popularity of opioid-related smartphone apps. Using web scraping, available information from 619 opioid-related apps (e.g., popularity metrics) was downloaded from Google Play, and 59 apps met criteria for review. The apps were additionally coded for quality by two raters using an 8-item screener for the American Psychiatric Association App Evaluation Model. FINDINGS: Sixty one percent of apps targeted patients, 29% providers, 8% the general community, and 2% healthcare trainees. Regarding app purpose, 49% addressed treatment, 27% prevention, and 24% overdose. Only one app met all criteria on the screener for quality, and there was no association between a total score calculated for the screener and measures of app popularity (e.g., star ratings; R2=0.10, p=0.19). SUMMARY: Opioid-related apps available for consumers addressed key stakeholders (patients, providers, community) and were consistent with strategies to address the opioid crisis (prevention, treatment, overdose). However, there was little evidence that available opioid-related apps meet basic quality standards, and no relationship was found between app quality and popularity. This review was conducted at the level of consumer decision-making (i.e., the app store), where only a handful of opioid-related apps met quality standards enough to warrant a more detailed evaluation of the app before recommendation for use. Because smartphone apps could be a critical tool to increase access to and utilization of opioid prevention, treatment, and recovery services, further development and testing is sorely needed.