Smartband-based smoking detection and real-time brief mindfulness intervention: findings from a feasibility clinical trial.

BACKGROUND: Smartbands can be used to detect cigarette smoking and deliver real time smoking interventions. Brief mindfulness interventions have been found to reduce smoking. OBJECTIVE: This single arm feasibility trial used a smartband to detect smoking and deliver brief mindfulness exercises. METHODS: Daily smokers who were motivated to reduce their smoking wore a smartband for 60 days. For 21 days, the smartband monitored, detected and notified the user of smoking in real time. After 21 days, a 'mindful smoking' exercise was triggered by detected smoking. After 28 days, a 'RAIN' (recognize, allow, investigate, nonidentify) exercise was delivered to predicted smoking. Participants received mindfulness exercises by text message and online mindfulness training. Feasibility measures included treatment fidelity, adherence and acceptability. RESULTS: Participants (N=155) were 54% female, 76% white non-Hispanic, and treatment starters (n=115) were analyzed. Treatment fidelity cutoffs were met, including for detecting smoking and delivering mindfulness exercises. Adherence was mixed, including moderate smartband use and low completion of mindfulness exercises. Acceptability was mixed, including high helpfulness ratings and mixed user experiences data. Retention of treatment starters was high (81.9%). CONCLUSIONS: Findings demonstrate the feasibility of using a smartband to track smoking and deliver quit smoking interventions contingent on smoking.

How healthcare providers and the right information may play a critical role in quitting success among smokers interested in using e-cigarettes for quitting: Results from a survey of U.S adults.

INTRODUCTION: Promoting smoking cessation is a global public health priority. E-cigarettes are increasingly being used by individuals to try quitting smoking. Identifying sources and types of information available to adults who are trying to quit, and the impact of this information during a quit attempt, is critical to augment the potential public health benefit of e-cigarettes for reducing cigarette smoking. METHODS: US adults (N = 857) who reported using e-cigarettes in a recent smoking cessation attempt completed an anonymous, cross sectional, online survey. We examined sources of information and type of information received when using e-cigarettes to quit smoking and their associations with the duration of abstinence achieved. RESULTS: The two most commonly reported information sources were friends (43.9%) and the internet (35.2%), while 14.0% received information from a healthcare provider. People received information on type of device (48.5%), flavor (46.3%), and nicotine concentration (43.6%). More people received information about gradually switching from smoking to vaping (46.7%) than abruptly switching (30.2%). Obtaining information from healthcare providers (ß (SE) = 0.16 (0.08), p = 0.04), getting information about abruptly switching to e-cigarettes (ß (SE) = 0.14 (0.06), p = 0.01) and what nicotine concentrations to use (ß (SE) = 0.18 (0.05), p = 0.03) were associated with longer quit durations. CONCLUSIONS: Amidst the growing popularity of e-cigarettes use for quitting smoking, our results highlight common sources of information and types of information received by individuals. Few people received information from healthcare providers indicating a gap in cessation support that can be filled. Providing information about immediate switching to e-cigarettes and nicotine concentrations to use may help in increasing quit rates and duration.

Evidence that personalized racial stress procedures elicit a stress response and increases alcohol craving among Black adults with alcohol use disorder: A laboratory pilot study.

BACKGROUND: The objective of this study was to pilot test newly developed personalized imagery procedures to investigate the impact of racial stress on alcohol craving and emotional and physiological response in Black adults with alcohol use disorder (AUD). METHODS: Twenty Black adults (45% women, meanage=37.05, SDage=13.19) with AUD participated in two sessions. In the first, participants described a stressful personal event involving their race and a neutral relaxing situation and these descriptions were used to develop scripts for the subsequent laboratory exposure session. The second session was an experimental provocation session in which participants reported on alcohol craving and emotional response before and after imagined exposure to stress and neutral conditions using personalized racial stress and neutral/relaxing scripts. Conditions were randomized and counterbalanced across subjects, and heart rate and blood pressure were assessed before and after each image. RESULTS: Alcohol craving and negative emotions significantly increased, and positive emotions decreased following the racial stress script relative to the neutral/relaxing script. We found no differences in physiological response. Exploratory analyses found that increase in alcohol craving was correlated with racial identity exploration but not racial identity commitment, men reported greater reductions in anger than women in the neutral condition only, and income was correlated with fear in the racial stress condition only. CONCLUSIONS: This study provides evidence that personalized racial stress procedures elicit a stress response and increases alcohol craving and emotional response but not physiological response among Black adults with AUD. These findings warrant replication in a larger study.

Reductions in World Health Organization risk drinking level are associated with improvements in sleep problems among individuals with alcohol use disorder.

AIMS: Among individuals with alcohol use disorder (AUD), sleep disturbances are pervasive and contribute to the etiology and maintenance of AUD. However, despite increased attention toward the relationship between alcohol use and sleep, limited empirical research has systematically examined whether reductions in drinking during treatment for AUD are associated with improvements in sleep problems. METHODS: We used data from a multisite, randomized, controlled trial that compared 6 months of treatment with gabapentin enacarbil extended-release with placebo for adults with moderate-to-severe AUD (N = 346). The Timeline Follow-back was used to assess WHO risk drinking level reductions and the Pittsburgh Sleep Quality Index was used to assess sleep quality over the prior month at baseline and the end of treatment. RESULTS: Sleep problem scores in the active medication and placebo groups improved equally. Fewer sleep problems were noted among individuals who achieved at least a 1-level reduction (B = -0.99, 95% confidence interval (CI) [-1.77, -0.20], P = .014) or at least a 2-level reduction (B = -0.80, 95% CI [-1.47, -0.14], P = .018) in WHO risk drinking levels at the end of treatment. Reductions in drinking, with abstainers excluded from the analysis, also predicted fewer sleep problems at the end of treatment (1-level: B = -1.01, 95% CI [-1.83, -0.20], P = .015; 2-level: B = -0.90, 95% CI [-1.59, -0.22], P = .010). CONCLUSIONS: Drinking reductions, including those short of abstinence, are associated with improvements in sleep problems during treatment for AUD. Additional assessment of the causal relationships between harm-reduction approaches to AUD and improvements in sleep is warranted.

Reductions in World Health Organization Risk Drinking Level Are Associated With Reductions in Alcohol Use Disorder Diagnosis and Criteria: Evidence From an Alcohol Pharmacotherapy Trial.

OBJECTIVES: This study aimed to evaluate the validity of World Health Organization (WHO) risk drinking level reductions as meaningful endpoints for clinical practice and research. This study examined whether such reductions were associated with a lower likelihood of a current alcohol use disorder (AUD) diagnosis and fewer AUD criteria. METHODS: We conducted a secondary data analysis to address these objectives using data from a multisite randomized controlled trial of gabapentin enacarbil extended release in treating moderate to severe AUD among adults (N = 346). Participants received gabapentin enacarbil extended release or placebo for 6 months. The timeline follow-back was used to assess WHO risk drinking level reductions, and the Mini-International Neuropsychiatric Interview was used to assess Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) AUD diagnosis and criteria at baseline (past year) and end of treatment (past month). RESULTS: Most participants (80.1%) achieved at least a 1-level reduction in the WHO risk drinking levels from baseline to end of treatment, and nearly half of participants (49.8%) achieved at least a 2-level reduction. At least a 1-level reduction or at least a 2-level reduction in WHO risk drinking level predicted lower odds of an active AUD diagnosis (1-level: odds ratio, 0.74 [95% confidence interval (CI), 0.66-0.84]; 2-level: odds ratio, 0.71 [95% CI, 0.64-0.79]) and fewer AUD criteria (1-level: B , -1.66 [95% CI, -2.35 to -0.98]; 2-level: B , -1.76 [95% CI, -2.31 to -1.21]) at end of treatment. CONCLUSIONS: World Health Organization risk drinking level reductions correlate with Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) AUD diagnosis and criteria, providing further evidence for their use as endpoints in alcohol intervention trials, which has potential implications for broadening the base of AUD treatment.

The Scientific Basis for the Regulation of Flavors in Tobacco Products.

Effective tobacco policies are important for reducing the harm of tobacco use and can have a broad impact at the population level. This review provides an overview of how clinical science can inform tobacco policies with a focus on policies related to flavored tobacco products, using menthol cigarettes as an illustrative example. Specifically, this review summarizes the role of flavors in tobacco use and the history of regulation of flavored tobacco products by the US Food and Drug Administration (FDA), provides an overview of clinical research methods used to contribute to the scientific evidence to inform FDA tobacco policies, discusses key findings related to menthol tobacco products using these methods, and proposes future directions for clinical research. As the tobacco marketplace continues to evolve with new products and flavor chemicals, ongoing clinical science will be essential for establishing evidence-based policies to protect public health and reduce tobacco-related health disparities.

Impaired Control (Both Attempts to Control Drinking and Failed Control) as Prospective Predictors of Negative Outcomes Among Young Adults Who Drink Heavily.

OBJECTIVE: Impaired control over alcohol is a hallmark of addiction relevant to young adults, but additional prospective findings are needed, particularly in samples reporting heavy drinking. Further, we lack understanding of how attempts and failed efforts to control drinking relate to each other in predicting outcomes. We hypothesized that attempted and failed control would prospectively predict outcomes, with endorsement of both being especially problematic. METHOD: We used data from young adults reporting heavy drinking who enrolled in laboratory alcohol self-administration studies (n = 109). Mixed-effects models were used to predict drinks per drinking day, heavy drinking, and negative consequences across baseline and 6- and 12-month follow-ups. Interactions by time and between attempted and failed control were tested. RESULTS: Higher failed control was associated with steeper declines in consequences and heavy drinking over time compared with lower failed control. However, higher attempted or failed control was still associated with more consequences and alcohol use than lower impaired control at multiple time points. A significant interaction indicated that the combination of higher attempted and failed control was associated with the most drinks per drinking day. There was also a significant Attempted × Failed Control interaction for heavy drinking. CONCLUSIONS: These findings provide further evidence supporting impaired control over alcohol use as a risk factor among young adults. Those reporting both higher attempted and failed control drank the most per day. Either attempted or failed control was associated with negative consequences. Those reporting both higher attempted and failed control may be in greatest need of intensive intervention.

Evidence of subgroup differences in meta-analyses evaluating medications for alcohol use disorder: An umbrella review.

Randomized controlled trials (RCTs) evaluating medications for alcohol use disorder (AUD) often examine heterogeneity of treatment effects through subgroup analyses that contrast effect estimates in groups of patients across individual demographic, clinical, and study design-related characteristics. However, these analyses are often not prespecified or adequately powered, highlighting the potential role of subgroup analyses in meta-analysis. Here, we conducted an umbrella review (i.e., a systematic review of meta-analyses) to determine the range and characteristics of reported subgroup analyses in meta-analyses of AUD medications. We searched PubMed to identify meta-analyses of RCTs evaluating medications for the management of AUD, alcohol abuse, or alcohol dependence in adults. We sought studies that measured drinking-related outcomes; quality of life, function, and rates of mortality; adverse events; and dropout. We considered meta-analyses that reported the results from formal subgroup analyses (comparing the summary effects across subgroup levels); summary effect estimates stratified across subgroup levels; and meta-regression, regression, or correlation-based subgroup analyses. We analyzed nine meta-analyses that included 61 formal subgroup analyses (median = 6 per meta-analysis), of which 33 (54%) were based on baseline participant-level and 28 (46%) were based on trial-level characteristics. Of the 58 subgroup analyses with either a p-value from a subgroup test or a statement by the authors that the subgroup analyses were not statistically significant, eight (14%) were statistically significant at the p < 0.05 level. Twelve meta-analyses reported the results of 102 meta-regression analyses, of which 25 (25%) identified statistically significant predictors of the relevant outcome of interest; nine (9%) were based on baseline participant-level and 93 (91%) were based on trial characteristics. Subgroup analyses across meta-analyses of AUD medications often focus on study-level characteristics, which may not be as clinically informative as subgroup analyses based on participant-level characteristics. Opportunities exist for future meta-analyses to standardize their subgroup methodology, focus on more clinically informative participant-level characteristics, and use predictive approaches to account for multiple relevant variables.

Reductions in WHO risk drinking levels correlate with alcohol craving among individuals with alcohol use disorder.

BACKGROUND: Abstinence has historically been considered the preferred goal of alcohol use disorder (AUD) treatment. However, most individuals with AUD do not want to abstain and many are able to reduce their drinking successfully. Craving is often a target of pharmacological and behavioral interventions for AUD, and reductions in craving may signal recovery. Whether reductions in drinking during AUD treatment are associated with reductions in craving has not been well examined. METHODS: We conducted secondary analyses of data from three AUD clinical trials (N's= 1327, 346, and 200). Drinking reductions from baseline to the end of treatment were measured as changes in World Health Organization (WHO) risk drinking levels; alcohol craving was measured using validated self-report measures. Regression analyses tested whether drinking reductions were associated with end-of-treatment craving reductions; moderation analyses tested whether associations between drinking reduction and end-of-treatment craving differed across AUD severity. RESULTS: Reductions of at least 1 or at least 2 WHO risk drinking levels were associated with lower craving (all p's < 0.05). Results were substantively similar after removing abstainers at the end-of-treatment. Associations between drinking reductions and craving were generally not moderated by AUD severity. CONCLUSIONS: Individuals with WHO risk drinking level reductions reported significantly lower craving, as compared to those who did not achieve meaningful reductions in drinking. The results demonstrate the utility of WHO risk drinking levels as AUD clinical trial endpoints and provide evidence that drinking reductions mitigate craving.

A thematic analysis of stress, substance-cue, and neutral/relaxing events to inform approaches for improving treatment among Black adults who use substances.

INTRODUCTION: To inform approaches for adapting substance use treatment for Black adults, the aim of this study was to thematically analyze the stressors, triggers for substance use, and neutral/relaxing events reported among Black adults who participated in a lab paradigm. METHODS: The sample included 36 Black adults (mean age [years] = 37.47, SD = 7.30; 53 % male, 12 (33 %) with alcohol use disorder, 12 (33 %) with cocaine use disorder, and 12 (33 %) healthy controls). All participants provided detailed stimulus and response context information on the most stressful event they experienced in the past year, an event that involved substance use, and a neutral/relaxing event in a structured interview using a scene development questionnaire, and this information was utilized to generate a personalized imagery script for each event using standardized procedures. Thematic analyses identified the key themes reported within scripts. RESULTS: Consistent with a prior thematic analysis on a majority White sample, we found the following themes for the stress scripts: Relational (Violation, Loss, Parenting, Betrayal, Isolation vs. support), Environmental (Housing, Legal), and Achievement (Employment, Role in household). However, our analyses also resulted in new stress themes: Relational (Violation-Racial Microaggressions) and Institutional (Time Wasted). The substance use scripts consisted of the following trigger themes: Social (Social Facilitation, Socially-Sanctioned Substance Use Event, Exposure to Substance Use Friends/Associates), Internal (Free Time, Boredom, Thoughts of Using Substance, Frustration, Reward), and Environment (Availability of Substance, Celebration, Party Environment, Food, Hot Day, Money/Payday). The neutral/relaxing scripts themes were: Outdoor Activities (Admiring Nature, People Watching, Observing Surroundings, Enjoying the Sun, Playing in the Sand, Walking), Quiet Activities (Silence/Quiet, Prayer, Reading), and Indoor Activities (Radio, Television, Bath/Shower, Bed/Chair, Observing from a Window). We found sex differences across scripts. CONCLUSIONS: The results suggest that Black people experience unique stressors (e.g., institutional and racial stressors) that are important to consider when modifying treatment to improve outcomes among this group. In addition to stressors, this study also identified high-risk situations involving triggers for use. Taken together these findings suggest targets for the tailoring of coping strategies that could be incorporated for the development of culturally relevant behavioral treatment for SUD.