Effects of in vivo NRT sampling on smoking abstinence and NRT adherence: A randomized clinical trial.

BACKGROUND: Nicotine replacement therapy (NRT) is an effective treatment but is associated with poor adherence during smoking cessation attempts. This study aimed to determine if In Vivo Sampling, an experiential intervention that includes sampling of NRT in-session, increases NRT adherence and smoking abstinence compared to standard smoking cessation behavioral counseling. METHODS: Eligible participants were under community corrections supervision and smoked five or more cigarettes per day for the past year. Participants were randomly assigned to receive either In Vivo Sampling or standard smoking cessation behavioral counseling. Both interventions involved four 30-minute sessions and received 12 weeks of combination NRT. Self-reported NRT adherence, quit attempts, and carbon monoxide (CO)-verified smoking cessation were measured at one, three-, and six-months post-intervention. RESULTS: From 2017-2022, 515 participants were enrolled and randomized. The In Vivo Sampling group had significantly greater mean adherence to patch and lozenge NRT regimens (71 % vs. 60 %, OR: 1.63, 95 % CI: 1.36-1.96, p<.001). The In Vivo group had a significantly higher likelihood of quit attempts across time (61 % vs. 53 %, OR: 1.4, 95 % CI: 1.05-1.87, p=.021). Groups did not significantly differ on the percent of participants who had quit smoking at 6 months post-intervention (17 % In Vivo Sampling vs. 13 % standard counseling, OR: 1.43, p=.24). CONCLUSION: In Vivo Sampling demonstrated better NRT adherence and quit attempts but similar cessation rates to standard behavioral counseling. The In Vivo Sampling intervention represents a novel approach that increased behaviors typically associated with successful cessation over standard behavioral counseling.

A Pilot Study to Test the Feasibility for a Randomized Controlled Trial of E-cigarettes as Harm Reduction Tools Among People Who Smoke and Previously Failed to Quit with Pharmacotherapy.

INTRODUCTION: We conducted a pilot study to test the feasibility of a future randomized controlled trial comparing e-cigarettes to traditional pharmacotherapy among people who smoke daily, were motivated to quit, and failed to quit within the past 5 years using pharmacotherapy. METHODS: Eligible participants were assigned to either: 1) an e-cigarette (n=20) or 2) combination nicotine replacement therapy (patches and lozenges) (n=10). Participants received 5 weeks of product and selected a quit date 1 week later. Assessments were completed weekly, and electronic diaries were completed each day. As a pilot randomized controlled trial, outcomes focus on effects sizes and not statistical significance. RESULTS: Participants in the e-cigarette and NRT groups had a mean age of 51 (SD=13) and 50 (SD=10) years old, were 55% and 60% female, and were 15% and 0% non-white, respectively. At least 90% of participants completed each weekly assessment, and 77% of participants completed at least 80% of daily diaries. Mean cigarettes smoked per day reduced from 18 (SD=6.2) to 2.4 (SD=4.4) per day in the e-cigarette group and 16.5 (SD=8.5) to 4.9 (SD=5.9) per day in the NRT group. Rates of biochemically confirmed 7-day point prevalence abstinence at the end of treatment were numerically, but not statistically, higher in the e-cigarette group than the NRT group (35% vs. 10%, OR=4.8, 95% CI=0.5-46.5). CONCLUSIONS: Among current daily cigarette smokers who have previously tried to quit and failed using standard pharmacotherapies, provision of an e-cigarette is a feasible intervention. A larger adequately powered trial is warranted. IMPLICATIONS: This pilot study suggests that e-cigarettes may serve as an acceptable harm reduction intervention for people who smoke who cannot quit smoking with traditional pharmacotherapy, but adequately powered randomized controlled trials are needed.

A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study.

BACKGROUND: Cigarette smoking has major detrimental effects on oral health. Tobacco interventions in dental settings are effective, but rarely delivered. The American Dental Hygienists Association recommends that oral health providers: Ask patients about tobacco use, Advise quitting tobacco use, and Refer to state quitlines (Ask-Advise-Refer; AAR). While AAR connects patients to counseling, it does not directly connect patients to medication. Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke. NRTS combined with AAR could be an effective tobacco treatment intervention for dental settings. METHODS: This manuscript describes the study protocol for the Free Samples for Health (FreSH) study, a group randomized clinical trial testing the effectiveness of NRTS + AAR vs. AAR alone on long-term smoking abstinence. Fifty dental practices in the Midwest and Northeast nodes of the National Dental Practice-Based Research Network are randomly assigned to provide AAR and either a 2-week supply of 14-mg nicotine patches and 4-mg nicotine lozenges (NRTS condition) or an electric toothbrush (ET condition). Approximately 1,200 patients who currently smoke-regardless of interest in quitting- are recruited during dental visits. Participants complete a baseline survey in-person, then after visit, 1-, 3-, and 6-month follow-up surveys remotely. The primary outcome is carbon monoxide-confirmed 7-day point prevalence abstinence from combustible tobacco measured at 6 months post-enrollment. Secondary outcomes include: 24-h intentional quit attempts, change in cigarettes smoked per day, NRT utilization, attitudes toward NRT, intention to use NRT, and intention to quit smoking. A key informant process evaluation and cost effectiveness analysis will provide information for future implementation of NRTS. DISCUSSION: This is the first clinical trial to assess the effectiveness of NRTS on promoting smoking cessation in dental settings. If effective, this treatment could be implemented to increase the provision of smoking cessation interventions in dental settings to provide an additional treatment access point for people who smoke. TRIAL REGISTRATION: Registered at ClincalTrials.gov (NCT05627596) on 11/25/2022.

Developing Catchment Area Data Dashboards for Cancer Centers: A Stakeholder- engaged Approach.

Background: Data dashboards that can communicate complex and diverse catchment area data effectively can transform cancer prevention and care delivery and strengthen community engagement efforts. Engaging stakeholders in data dashboard development, by seeking their inputs and collecting feedback, has the potential to maximize user-centeredness. Objective: To describe a systematic, stakeholder-driven, and theory-based approach for developing catchment area data visualization tools for cancer centers. Methods: Cancer-relevant catchment area data were identified from national- and state-level data sources (including cancer registries, national surveys, and administrative claims databases). A prototype tool for data visualization was designed, developed, and tested based on the OPT-In [ O rganize, P lan, T est, In tegrate] framework. A working group of multi-disciplinary experts collected stakeholder feedback through formative assessment to understand data and design preferences. Thematic areas, data elements, and the composition and placement of data visuals in the prototype were identified and refined by working group members. Visualizations were rendered in Tableau © and embedded in a public-facing website. A mixed-method approach was used to assess the understandability and actionability of the tool and to collect open-ended feedback that informed action items for improvisation. Results: We developed a visualization dashboard that illustrates cancer incidence and mortality, risk factor prevalence, healthcare access, and social determinants of health for the Hollings Cancer Center catchment area. Color-coded maps, time-series plots, and graphs illustrate these catchment area data. A total of 21 participants representing key stakeholders [general audience (n=4), community advisory board members and other representatives (n=7), and researchers (n=10)] were identified. The understandability and actionability scores exceeded the minimum (80%) threshold. Stakeholders' feedback confirmed that the tool is effective in communicating cancer data and is useful for education and advocacy. Themes that emerged from qualitative data suggest that additional changes to the tool such as a warm color palette, data source transparency, and the addition of analytical features (data overlaying and area-resolution selection) would further enhance the tool. Integration of communication efforts and messages within a broader context is in progress. Discussion: A catchment area data resource developed through a systematic, stakeholder- driven, and theory-based approach can meet (and surpass) benchmarks for understandability and actionability, and lead to an overall positive response from stakeholders. Creating channels for advocacy and forming community partnerships will be the next step necessary to promote policies and programs for improving cancer outcomes in the catchment areas.

The prospective relationship between a-priori intentions for and patterns of e-cigarette use among adults who smoke cigarettes.

BACKGROUND: Electronic (e-)cigarettes may help adult cigarette smokers achieve cigarette cessation, depending on patterns of e-cigarette use. Among cigarette smokers who do not use e-cigarettes, it is unclear if and how a-priori intentions for use are related to uptake patterns. Longitudinal studies have focused on established e-cigarette users or adolescent and young adult populations exclusively. METHODS: Within a nationwide randomized clinical trial (N = 638), adult cigarette smokers not currently using e-cigarettes were randomized (2:1) to receive (or not) one-month sampling of e-cigarettes. An exploratory factor analysis (EFA) was performed on an established 15-item measure assessing a-priori intentions for e-cigarette use to identify latent variables. Among those receiving e-cigarette products, regression models examined relationships between intentions and: 1) uptake (yes/no), 2) frequency (number of days per week), and 3) amount (puffing episodes per day) of e-cigarette use at one-month follow-up. RESULTS: Two factors emerged from the EFA: 1) cigarette-related intentions (e.g., cigarette cessation, no smell) and 2) novel appeal of e-cigarettes (e.g., flavors). Three items remained and were treated as separate intentions: "feels like cigarette smoking", "curiosity", and "affordability". In the final multivariable models, "feel like cigarette smoking" predicted more frequent e-cigarette use (ß = 0.187, SE = 0.086, p = 0.03); however, none of the five factors/intentions were significantly associated with uptake or amount of use. CONCLUSIONS: For adult cigarette smokers not currently using e-cigarettes, a-priori intentions for using e-cigarettes might not be predictive of if or how these products will be used in the future, suggesting that motives may not drive use behavior.

Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.

OBJECTIVES: Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population. METHODS: This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries. RESULTS: The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use. CONCLUSIONS: There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers.

Development of two novel treatments to promote smoking cessation: Savor and retrieval-extinction training pilot clinical trial findings.

Despite decades of progress, cigarette smoking remains a significant contributor to disease burden. This effect is especially pronounced for specific priority populations, such as individuals who live in rural communities, in that the burden of tobacco smoking is greater among these groups than in urban areas and the general population. The present study aims to evaluate the feasibility and acceptability of two novel tobacco treatment interventions delivered through remote telehealth procedures to individuals who smoke in the state of South Carolina. Results also include exploratory analyses of smoking cessation outcomes. Study I evaluated savoring, a strategy based on mindfulness practices, alongside nicotine replacement therapy (NRT). Study II evaluated retrieval-extinction training (RET), a memory-modification paradigm alongside NRT. In Study I (savoring), recruitment and retention data showed high interest and engagement in the intervention components, and participants who received this intervention decreased cigarette smoking throughout the course of the treatment (ps < .05). In Study II (RET), results showed high interest and moderate engagement in treatment, although exploratory outcome analyses did not demonstrate significant treatment effects on smoking behaviors. Overall, both studies showed promise in generating interest among individuals who smoke in participating in remotely delivered, telehealth smoking cessation interventions with novel therapeutic targets. A brief savoring intervention appeared to have effects on cigarette smoking throughout treatment, whereas RET did not. Gaining insight from the present pilot study, future studies may improve the efficacy of these procedures and incorporate the treatment components into more robust available treatments. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Dental staff and patient attitudes about nicotine replacement therapy samples in dental care: A National Dental Practice-Based Research Network study.

OBJECTIVES: Cigarette smoking negatively affects oral health. Nicotine replacement therapies (NRT; e.g. nicotine patch or lozenge) and brief interventions (e.g. Ask-Advise-Refer; AAR) can improve cessation outcomes but are underutilized. NRT sampling (NRTS) increases NRT utilization by providing patients with samples of NRT as part of routine healthcare. Ask-Advise-Refer is a brief intervention where practitioners: ask patients about tobacco use, advise those using tobacco to quit and refer to the state quit line. The objective of this qualitative study was to explore dental care practitioners' and patients' attitudes and experiences regarding tobacco cessation treatment and perceptions of two brief intervention models, assessed separately: NRTS and AAR. METHODS: Twenty-four dental care practitioners and nine patients, recruited through the National Dental Practice-Based Research Network, participated in semi-structured telephone interviews. Interviews assessed experiences with tobacco use intervention and attitudes towards NRTS and AAR. Thematic analysis identified emergent themes related to feasibility and acceptability of NRTS and AAR. RESULTS: Practitioners varied on how they address tobacco use, from systematically to idiosyncratically. Some practitioners recommend NRT; few had prescribed it. Practitioners had favourable attitudes towards AAR and NRTS, with most believing that both interventions would be acceptable and feasible to implement. Concerns regarding AAR were time and patient resistance to discussing tobacco use. Concerns regarding NRTS were patient resistance to using NRT, side effects or medication interactions, and capacity to provide follow-up. Patients reported that oral health practitioners generally ask about tobacco use but do not provide interventions. Patients were open to discussing their tobacco use with practitioners and had favourable attitudes about NRTS. CONCLUSIONS: This formative work suggests that NRTS and AAR may be feasible to implement in dental care settings. Future studies are needed to assess the effectiveness and implementation potential of NRTS in dental care settings.

Behavioral Activation-Based Digital Smoking Cessation Intervention for Individuals With Depressive Symptoms: Randomized Clinical Trial.

BACKGROUND: Depression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers. OBJECTIVE: This study aimed to determine whether a mobile app-based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation. METHODS: A 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app ("Goal2Quit") provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA). RESULTS: In total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02). CONCLUSIONS: A mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments. TRIAL REGISTRATION: ClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379.

Remote Carbon Monoxide Capture via REDCap: Evaluation of an Integrated Mobile Application.

INTRODUCTION: To improve the feasibility of remote biochemical verification of smoking status, our team developed "COast", a mobile app integrated with REDCap that allows a research participant to complete self-report research assessments and provide a breath sample via the iCOQuit® Smokerlyzer® for the purposes of carbon monoxide (CO) testing. The aims of the present study were to examine: 1) the validity of remote CO data capture using COast as compared to gold standard approaches (salivary cotinine, stand-alone CO monitor) and 2) the feasibility of remote CO data capture using COast as applied to both daily and weekly CO collection schedules. METHODS: Participants (N=143, 59% Female), including recently quit (n=36) and current (n=107) smokers, completed a baseline video session to capture validity data, and then were randomized to daily or weekly CO monitoring for a period of one month. RESULTS: Balancing both sensitivity and specificity, optimal cut-points for defining abstinence using the COast system were < 4 parts per million (ppm) with salivary cotinine as the referent (Sensitivity = 100%, Specificity = 92.8%) and < 8ppm with the stand-alone CO monitor as the referent (Sensitivity = 100%, Specificity = 88.9%). Compliance across groups with CO monitoring was high with average compliance of 74% for the daily group and 84% for the weekly group. Self-reported feasibility and acceptability of using the system were strong. CONCLUSIONS: Pairing the iCOQuit with REDCap via the COast app was both valid and feasible among a sample of adults who smoke cigarettes enrolled remotely. This integration may help to improve the rigor of decentralized smoking cessation trials. IMPLICATIONS: With increasing prevalence of decentralized trial designs, innovative methods are needed to remotely capture biomarkers. Methods that leverage existing widely available research data capture platforms may be particularly useful for promoting adoption. The COast app, which integrates a Bluetooth-enabled carbon monoxide monitor with REDCap, is a fitting, valid, feasible solution to remotely biochemically verify smoking status.

Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial.

Background: As summarised in the most recent Cochrane review, the few clinical trials on e-cigarettes are largely focused on smoking cessation. We aimed to determine the naturalistic uptake, use, and impact of e-cigarettes among adults who may or may not want to stop smoking. Methods: In this naturalistic, randomised, controlled clinical trial, adult smokers, across the motivational spectrum and with minimal history of e-cigarette use, were recruited online from the general community within 11 cities across the USA. Participants were randomly assigned (2:1) to either receive either a free 4-week supply of flavoured, tank-style e-cigarette, or not. E-cigarette group participants received a battery and device with up to 30 pre-filled tanks, offered among five flavours, with minimal instructions on use. The study's primary purpose was to descriptively assess naturalistic uptake and usage of the e-cigarette, and to secondarily assess its impact on smoking behavior. The latter, assessed through six months of follow-up, included: a) self-reported 7-day point prevalence abstinence, b) incidence of quit attempts, and c) smoking reduction. This trial is registered at ClinicalTrials.gov, NCT03453385. Findings: Between 5/2018 and 3/2022, 638 adult smokers were enrolled and randomly assigned (427 in the e-cigarette group and 211 in the no-product control group). Uptake of e-cigarettes was robust: approximately 70% of participants used the product, with average usage exceeding 4 days per week during the initial 30 days. Based on an intent-to-treat approach where missing data is imputed as smoking, almost all behavioral outcomes favored the e-cigarette group relative to no-product control, including point prevalence abstinence at six months (Odds Ratio [OR] = 1.8; 95% Confidence Interval [CI] = 1.0-3.1), cumulative incidence of 24-hr quit attempts (OR = 1.5; 95% CI = 1.0-2.2), and having reduced smoking by at least 50% since baseline (OR = 1.8; 95% CI = 1.2-2.7). Results were similar under an alternative imputation. Interpretation: Complementing cessation-focused trials, results suggest that unguided e-cigarette use also leads to smoking cessation, allaying the notion that causal effects of e-cigarettes on cessation are not reflective of real-world scenario of self-determined use. For smokers who may not be able to quit using existing pharmacologic approaches, e-cigarettes may be considered to achive that purpose. Funding: National Cancer Institute.

Monitoring Cigarette Smoking and Relapse in Young Adults With and Without Remote Biochemical Verification: Randomized Brief Cessation Study.

BACKGROUND: Technological advancements to study young adult smoking, relapse, and to deliver interventions remotely offer conceptual appeal, but the incorporation of technological enhancement must demonstrate benefit over traditional methods without adversely affecting outcomes. Further, integrating remote biochemical verification of smoking and abstinence may yield value in the confirmation of self-reported smoking, in addition to ecologically valid, real-time assessments. OBJECTIVE: The goal of this study was to evaluate the impact of remote biochemical verification on 24-hour self-reported smoking and biochemical verification agreement, retention, compliance with remote sessions, and abstinence during a brief, 5-week cessation attempt and relapse monitoring phase. METHODS: Participants (N=39; aged 18-25 years; mean age 21.6, SD 2.1 years; n=22, 56% male; n=29, 74% White) who smoked cigarettes daily engaged in a 5-week cessation and monitoring study (including a 48-hour quit attempt and provision of tobacco treatment in the form of nicotine replacement therapy, brief cessation counseling, and financial incentives for abstinence during the 2-day quit attempt only). Smoking (cigarettes per day) was self-reported through ecological momentary assessment (EMA) procedures, and participants were randomized to either (1) the inclusion of remote biochemical verification (EMA + remote carbon monoxide [rCO]) 2× per day or (2) in-person, weekly CO (wCO). Groups were compared on the following outcomes: (1) agreement in self-reported smoking and breath carbon monoxide (CO) at common study time points, (2) EMA session compliance, (3) retention in study procedures, and (4) abstinence from smoking during the 2-day quit attempt and at the end of the 5-week study. RESULTS: No significant differences were demonstrated between the rCO group and the wCO (weekly in-person study visit) group on agreement between 24-hour self-reported smoking and breath CO (moderate to poor), compliance with remote sessions, or retention, though these outcomes numerically favored the wCO group. Abstinence was numerically higher in the wCO group after the 2-day quit attempt and significantly different at the end of treatment (day 35), favoring the wCO group. CONCLUSIONS: Though study results should be interpreted with caution given the small sample size, findings suggest that the inclusion of rCO breath added to EMA compared to EMA with weekly, in-person CO collection in young adults did not yield benefit and may have even adversely affected outcomes. Our results suggest that technological advancements may improve data accuracy through objective measurement but may also introduce barriers and burdens and could result in higher rates of missing data. The inclusion of technology to inform smoking cessation research and intervention delivery among young adults should consider (1) the research question and necessity of biochemical verification and then (2) how to seamlessly incorporate monitoring into personalized and dynamic systems to avoid the added burden and detrimental effects to compliance and honesty in self-report.

Preliminary effectiveness of online opioid overdose and naloxone administration training and impact of naloxone possession on opioid use.

BACKGROUND: Despite the demonstrated value of opioid overdose education and naloxone distribution (OEND) programs, uptake and utilization remains low. Accessibility to OEND is limited and traditional programs may not reach many high-risk individuals. This study evaluated the effectiveness of online opioid overdose and naloxone administration education and the impact of naloxone possession. METHODS: Individuals with self-reported illicit use of opioids were recruited via Craigslist advertisements and completed all assessments and education online via REDCap. Participants watched a 20-minute video outlining signs of opioid overdose and how to administer naloxone. They were then randomized to either receive a naloxone kit or be given instructions on where to obtain a kit. Effectiveness of training was measured with pre- and post-training knowledge questionnaires. Naloxone kit possession, overdoses, opioid use frequency, and treatment interest were self-reported on monthly follow-up assessments. RESULTS: Mean knowledge scores significantly increased from 6.82/9.00 to 8.22 after training (t(194)=6.85, p <0.001, 95% CI[1.00, 1.81], Cohen's d=0.85). Difference in naloxone possession between randomized groups was significant with a large effect size (p <0.001, diff=0.60, 95% CI[0.47, 0.73]). A bidirectional relationship was found between naloxone possession and frequency of opioid use. Overdoses and treatment interest were similar across possession status. CONCLUSIONS: Overdose education is effective in online video format. Disparity in naloxone possession across groups indicates barriers to obtaining naloxone from pharmacies. Naloxone possession did not influence risky opioid use or treatment interest and its impact on frequency of use warrants further investigation. TRIAL REGISTRATION: Clinitaltrials.gov-NCT04303000.

A Secondary Analysis of a Preliminary Contingency Management Intervention for Presurgical Cancer Patients: Evaluating Individual Participant Data.

INTRODUCTION: Contingency management (CM) interventions deliver monetary reinforcers contingent upon biochemically verified abstinence from smoking. CM has been found to be effective, however, individual participant, analyses are warranted to further elucidate how individual-level behavior patterns vary during the intervention period, both within and across treatment groups. AIMS AND METHODS: This is a secondary analysis of a randomized controlled pilot trial of presurgical cancer patients who smoke (RCT N = 40). All participants were current everyday smokers and were enrolled in cessation counseling, offered nicotine replacement therapy, and submitted breath CO testing 3 times per week for 2-5 weeks. Participants randomized to CM received monetary reinforcers for breath CO ≤6 ppm on an escalating schedule of reinforcement with a reset for positive samples. Sufficient breath CO data exist for 28 participants (CM = 14; monitoring only [MO] = 14). Effect size was calculated for differences in negative CO tests. Time to first negative test was tested using survival analysis. Fisher's exact test was used to assess relapse. RESULTS: The CM group achieved abstinence more quickly (p < .05), had a lower percentage of positive tests (h = 0.80), and experienced fewer lapses following abstinence (p = .00). While 11 of 14 participants in the CM group achieved and sustained abstinence by their third breath test, this was only true for 2 of the 14 MO participants. CONCLUSIONS: Those in CM achieved abstinence quicker and with fewer lapses than those engaged in MO speaking to the efficacy of the schedule of financial reinforcement. This is particularly important within presurgical populations given the potential benefits to postoperative cardiovascular and wound infection risk. IMPLICATIONS: While the efficacy of CM as an intervention is well established, this secondary analysis provides insight into the individual behavior patterns underlying successful abstinence. Those assigned to CM were not only more likely to achieve abstinence, but did so more quickly and with fewer instances of relapse. This is of particular importance to those scheduled for surgery where achieving abstinence as early as possible impacts on the risk of postoperative complications. CM interventions may be particularly well suited for critical windows in which timely and sustained abstinence is advantageous.

Who responds to a multi-component treatment for cannabis use disorder? Using multivariable and machine learning models to classify treatment responders and non-responders.

BACKGROUND AND AIMS: Treatments for cannabis use disorder (CUD) have limited efficacy and little is known about who responds to existing treatments. Accurately predicting who will respond to treatment can improve clinical decision-making by allowing clinicians to offer the most appropriate level and type of care. This study aimed to determine whether multivariable/machine learning models can be used to classify CUD treatment responders versus non-responders. METHODS: This secondary analysis used data from a National Drug Abuse Treatment Clinical Trials Network multi-site outpatient clinical trial in the United States. Adults with CUD (n = 302) received 12 weeks of contingency management, brief cessation counseling and were randomized to receive additionally either (1) N-Acetylcysteine or (2) placebo. Multivariable/machine learning models were used to classify treatment responders (i.e. two consecutive negative urine cannabinoid tests or a 50% reduction in days of use) versus non-responders using baseline demographic, medical, psychiatric and substance use information. RESULTS: Prediction performance for various machine learning and regression prediction models yielded area under the curves (AUCs) >0.70 for four models (0.72-0.77), with support vector machine models having the highest overall accuracy (73%; 95% CI = 68-78%) and AUC (0.77; 95% CI = 0.72, 0.83). Fourteen variables were retained in at least three of four top models, including demographic (ethnicity, education), medical (diastolic/systolic blood pressure, overall health, neurological diagnosis), psychiatric (depressive symptoms, generalized anxiety disorder, antisocial personality disorder) and substance use (tobacco smoker, baseline cannabinoid level, amphetamine use, age of experimentation with other substances, cannabis withdrawal intensity) characteristics. CONCLUSIONS: Multivariable/machine learning models can improve on chance prediction of treatment response to outpatient cannabis use disorder treatment, although further improvements in prediction performance are likely necessary for decisions about clinical care.

Genetic Associations with Smoking Relapse and Proportion of Follow-up in Smoking Relapse throughout Adulthood in Pre- and Postmenopausal Women.

PREVENTION RELEVANCE: This study is the first to quantify genetic associations with smoking relapse among female smokers throughout adulthood. These findings could inform precision medicine approaches to improve long-term smoking relapse prevention to reduce smoking attributable cancer morbidity and mortality.

Feasibility and acceptability of online opioid overdose education and naloxone distribution: Study protocol and preliminary results from a randomized pilot clinical trial.

Drug overdose is the leading cause of accidental death in the United States, with over 70% of drug related fatalities resulting from the use of opioids. Federal agencies have responded to this crisis with various recommendations including enhancing harm reduction approaches such as training laypersons to administer naloxone through Opioid Overdose Education and Naloxone Distribution (OEND) programs. Several studies have demonstrated that OEND programs effectively reduce opioid overdose mortality and are both safe and cost-effective, however, they are typically implemented in urban areas as part of large medical center research programs, needle exchanges, or drug treatment programs. Individuals living in areas without these programs or services lack access to critical and life-saving OEND. The current study examined the acceptability and feasibility of online recruitment, online opioid overdose education, and remote distribution of naloxone kits. Persons who illicitly use opioids and are at risk for overdose were recruited through online media and completed an opioid use questionnaire. If interested in receiving opioid overdose and naloxone administration training, participants completed pre- and post-intervention knowledge questionnaires, engaged in audiovisual training, and were randomized to either receive a naloxone kit or be given information on where they could obtain one. Preliminary results indicate feasibility and acceptability as evidenced by strong recruitment and retention, as well as high participant satisfaction ratings. Successful implementation of remote OEND through this project supports future employment of similar remote programs to expand this critical harm reduction strategy to high-risk individuals in areas lacking traditional OEND programs. Trial Registration #: Clinitaltrials.gov- NCT04303000.