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1.
Ann Med ; 56(1): 2352803, 2024 Dec.
Article in English | MEDLINE | ID: mdl-38823419

ABSTRACT

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.


Subject(s)
Feasibility Studies , Mindfulness , Smoking Cessation , Humans , Female , Mindfulness/methods , Male , Smoking Cessation/methods , Smoking Cessation/psychology , Middle Aged , Adult , Patient Compliance , Text Messaging , Smoking/therapy , Smoking/psychology
2.
Am J Prev Med ; 2024 May 21.
Article in English | MEDLINE | ID: mdl-38782105

ABSTRACT

INTRODUCTION: Preventing nicotine use among youth is a public health priority. Nicotine use emerges from complex relationships between numerous factors. This project used network analysis to model behavioral precursors of nicotine use (knowledge, attitudes, perceptions, intentions) among youth who had never used nicotine and determine which predicted future trajectories of use across multiple nicotine products. METHODS: Data were from the Population Assessment of Tobacco and Health study (2013-2018; analyzed 2023-2024), youth ages 12-17, who reported never using nicotine at Wave 1. Network structure was determined for behavioral precursors at Wave 1 and central network nodes were identified (N=5087). Central nodes were then tested as predictors of trajectories of use across multiple nicotine products during Waves 1-4 (N=3851). RESULTS: Central nodes of the Wave 1 network were harm perception, expectancy that tobacco would calm anger/reduce stress, and intention to try. Those with lower intent to try at Wave 1 had lower odds of being in an Experimentation or Use class vs a Nonuse class during Waves 1-4 (p<.0001). Those with more accurate harm perception had lower odds of being in an Experimentation vs Non-use class (p=.004). Those with positive expectancies had higher odds of being in an Experimentation vs Non-use or Use class (p=.04,.02). CONCLUSIONS: Findings suggest a network model of behavioral precursors of nicotine use that can be tested, including central nodes that predicted trajectories of use across multiple nicotine products, and therefore may be priority intervention targets.

3.
J Clin Med ; 13(7)2024 Apr 08.
Article in English | MEDLINE | ID: mdl-38610919

ABSTRACT

Background: In 1990, the United States' Institute of Medicine promoted the principles of outcomes monitoring in the alcohol and other drugs treatment field to improve the evidence synthesis and quality of research. While various national outcome measures have been developed and employed, no global consensus on standard measurement has been agreed for addiction. It is thus timely to build an international consensus. Convened by the International Consortium for Health Outcomes Measurement (ICHOM), an international, multi-disciplinary working group reviewed the existing literature and reached consensus for a globally applicable minimum set of outcome measures for people who seek treatment for addiction. Methods: To this end, 26 addiction experts from 11 countries and 5 continents, including people with lived experience (n = 5; 19%), convened over 16 months (December 2018-March 2020) to develop recommendations for a minimum set of outcome measures. A structured, consensus-building, modified Delphi process was employed. Evidence-based proposals for the minimum set of measures were generated and discussed across eight videoconferences and in a subsequent structured online consultation. The resulting set was reviewed by 123 professionals and 34 people with lived experience internationally. Results: The final consensus-based recommendation includes alcohol, substance, and tobacco use disorders, as well as gambling and gaming disorders in people aged 12 years and older. Recommended outcome domains are frequency and quantity of addictive disorders, symptom burden, health-related quality of life, global functioning, psychosocial functioning, and overall physical and mental health and wellbeing. Standard case-mix (moderator) variables and measurement time points are also recommended. Conclusions: Use of consistent and meaningful outcome measurement facilitates carer-patient relations, shared decision-making, service improvement, benchmarking, and evidence synthesis for the evaluation of addiction treatment services and the dissemination of best practices. The consensus set of recommended outcomes is freely available for adoption in healthcare settings globally.

4.
Prev Med ; 183: 107956, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38615947

ABSTRACT

OBJECTIVE: This study utilized a socioecological approach to prospectively identify intrapersonal, familial, and environmental factors associated with single nicotine product use (NPU) and multiple NPU among U.S. youth. METHODS: Participants were 10,029 youths (ages 12-17 years) who had completed the Population Assessment of Tobacco Health study's Wave 1 (2013-2014) and Wave 4 (2016-2018) assessments and data on past 30-day nicotine product use. Multinomial logistic regression was fit for the 3-level outcome (no use, single NPU, multiple NPU) to estimate adjusted associations between the predictors and the outcome. RESULTS: The current study found that intrapersonal (sex, age, race/ethnicity, internalizing symptoms, sensation seeking, harm perceptions, lifetime history of using two or more tobacco products), familial (parental discussion about not using tobacco and living with someone who uses tobacco products) and environmental factors (exposure to tobacco advertising) commonly associated with tobacco use differentiated between individuals who later reported past 30-day NPU (either multiple or single NPU) from those who did not report past 30-day NPU. One familial factor only differentiated between lifetime users who were single NPUs from those who reported no NPU: non-combustible tobacco product use allowed anywhere in the home. Intrapersonal factors differentiated multiple NPU from single NPU: older age, being male, lifetime history of using nicotine product and less harm perceptions. CONCLUSIONS: This study identified factors that may be studied to prevent any NPU, along with factors that may be studied to promote harm reduction by preventing escalation of single NPU to problematic patterns of multiple NPU.


Subject(s)
Tobacco Products , Humans , Adolescent , Male , Female , United States/epidemiology , Child , Tobacco Products/statistics & numerical data , Tobacco Use/epidemiology , Prospective Studies , Risk Factors
5.
BMC Psychiatry ; 24(1): 201, 2024 Mar 12.
Article in English | MEDLINE | ID: mdl-38475757

ABSTRACT

BACKGROUND: Menthol cigarette use remains a large public health problem and disproportionately affects Black adults in the United States. The Food and Drug Administration has proposed prohibiting menthol flavor in cigarettes to protect public health. However, e-cigarettes are available in menthol flavor and are a popular alternative product adults might switch to if menthol is prohibited in cigarettes. Research is needed to understand how availability of menthol (vs. tobacco) flavored e-cigarettes could impact cigarette use among adults who smoke menthol cigarettes. METHODS: We will recruit 150 adults who currently smoke menthol cigarettes and will randomize them to 1 of 3 conditions modeling different regulatory scenarios. We will recruit equal numbers of participants identifying as Black vs. non-Black and will stratify randomization by race. To promote standardization and adherence, cigarette and e-cigarette products will be provided for 8 weeks based on the assigned condition: (A) no menthol restriction (menthol cigarette and menthol flavored e-cigarette), (B) menthol prohibited in cigarettes only (non-menthol cigarette and menthol flavored e-cigarette), (C) menthol prohibited in both cigarettes and e-cigarettes (non-menthol cigarette and tobacco flavored e-cigarette). A follow-up visit will occur at week 12 to assess tobacco use status. The study aims are to (1) examine the impact of prohibiting menthol flavor in cigarettes and e-cigarettes on smoking behavior and (2) investigate whether outcomes differ by race to understand the impact of menthol policies on Black (vs. non-Black) individuals given high rates of menthol cigarette use in this population. The primary outcome will evaluate changes in the number of cigarettes smoked per day during the 8-week study period and will examine differences by regulatory scenario. Secondary outcomes will compare percent days smoke-free, changes in nicotine dependence, and motivation, confidence, and intentions to quit smoking by the regulatory scenarios. We will examine whether changes in the outcomes differ by Black vs. non-Black participants to compare the magnitude of the effect of the various menthol policy scenarios by race. DISCUSSION: Results will contribute critical information regarding menthol in cigarettes and e-cigarettes to inform regulatory policies that maximize reductions in cigarette smoking and reduce tobacco-related health disparities. TRIAL REGISTRATION: NCT05259566. Yale IRB protocol #2000032211, last approved 12/8/2023.


Subject(s)
Cigarette Smoking , Electronic Nicotine Delivery Systems , Tobacco Products , Adult , Humans , United States , Menthol , Cigarette Smoking/epidemiology , Flavoring Agents , Tobacco Control , Randomized Controlled Trials as Topic
6.
Int J Eat Disord ; 57(5): 1268-1273, 2024 May.
Article in English | MEDLINE | ID: mdl-38321617

ABSTRACT

OBJECTIVE: To test whether overvaluation of shape/weight at the end of treatment prospectively predicts relapse at 12-month follow-up in patients with binge-eating disorder (BED). METHOD: Participants were 129 patients with BED who achieved abstinence from binge eating after 6 months of behaviorally-based weight-loss treatments in a clinical trial. Independent assessments conducted at posttreatment and at 12-month follow-up included the Eating Disorder Examination interview, the Beck Depression Inventory, and weight measurements. RESULTS: Of the 129 participants who attained abstinence from binge-eating at posttreatment, 46 (36%) were categorized with clinical overvaluation and 83 (64%) with subclinical overvaluation; 115 (89%) were re-assessed at 12-month follow-up. Participants with overvaluation at posttreatment were significantly more likely than those without to relapse at 12-months to non-abstinence from binge eating (54% vs. 28%) and to diagnosis-level binge-eating frequency of once weekly or greater (31% vs. 13%). Overvaluation at posttreatment predicted significantly higher eating-disorder psychopathology and depression scores at 12-month follow-up but were unrelated to weight and weight changes. Treatment groups did not have main or interaction effects; posttreatment overvaluation effects were observed regardless of treatment and of covarying for posttreatment value of dependent variables. CONCLUSIONS: Our findings suggest that overvaluation of shape/weight at the end of treatment predicts relapse and heightened eating-disorder psychopathology and depression scores 1 year later in patients who achieved abstinence from binge eating with behaviorally-based treatments. Overvaluation of shape/weight has significant clinical implications and warrants consideration as a diagnostic specifier for BED as it provides important prospective prognostic information. PUBLIC SIGNIFICANCE: Although effective treatments are available for binge-eating disorder, relapse following successful treatments is not uncommon. Almost nothing is known about what predicts relapse following treatments for binge-eating disorder. Our study found that overvaluation of shape/weight (i.e., body image concerns that overly impact self-worth) at posttreatment prospectively predicted relapse and higher eating-disorder psychopathology and depression 1 year later in patients who achieved binge-eating abstinence with behaviorally based treatments. CLINICALTRIALS: gov registration: NCT00829283. (Treatment of obesity and binge eating: Behavioral weight loss vs. stepped care.).


Subject(s)
Binge-Eating Disorder , Body Image , Body Weight , Recurrence , Humans , Binge-Eating Disorder/therapy , Female , Adult , Male , Follow-Up Studies , Middle Aged , Treatment Outcome , Behavior Therapy/methods
7.
Nicotine Tob Res ; 2024 Feb 17.
Article in English | MEDLINE | ID: mdl-38367211

ABSTRACT

INTRODUCTION: In the dopamine system, the mesolimbic pathway, including the dorsal striatum, underlies the reinforcing properties of tobacco smoking, and the mesocortical pathway, including the dorsolateral prefrontal cortex (dlPFC), is critical for cognitive functioning. Dysregulated dopamine signaling has been linked to drug-seeking behaviors and cognitbie deficits. The dorsal striatum and dlPFC are structurally and functionally connected and are the key regions for cognitive functioning. We recently showed that people who smoke have lower dlPFC dopamine (D2/3R) receptor availability than people who do not, which is related to poorer cognitive function. The goal of this study was to examine the same brain-behavior relationship in the dorsal striatum. METHODS: Twenty-nine (18 males) recently abstinent people who smoke and twenty-nine sex-matched healthy controls participated in two same-day [11C]-(+)-PHNO positron emission tomography scans before and after amphetamine administration to provoke dopamine release. D2/3R availability (binding potential; BPND) and amphetamine-induced dopamine release (%ΔBPND) were calculated. Cognition (verbal learning and memory) was assessed with the CogState computerized battery. RESULTS: There were no group differences in baseline BPND. People who smoke have a smaller magnitude %ΔBPND in dorsal putamen than healthy controls (p=0.022). People who smoke perform worse on immediate (p=0.035) and delayed (p=0.011) recall than healthy controls. In all people, lower dorsal putamen BPND was associated with worse immediate (p=0.006) and delayed recall (p=0.049), and lower %ΔBPND was related to worse delayed recall (p=0.022). CONCLUSION: Lower dorsal putamen D2/3R availability and function are associated with disruptions in cognitive function that may underlie difficulty with resisting smoking. IMPLICATIONS: This study directly relates dopamine imaging outcomes in the dorsal striatum to cognitive function in recently abstinent people who smoke cigarettes and healthy controls. The current work included a well-characterized subject sample in terms of demographics, smoking characteristics, and a validated neurocognitive test of verbal learning and memory. The findings of this study extend previous literature relating dopamine imaging outcomes to cognition in recently abstinent people who smoke and people who do not smoke, expanding our understanding of brain-behavior relationships.

8.
Science ; 383(6679): 164-167, 2024 01 12.
Article in English | MEDLINE | ID: mdl-38207039

ABSTRACT

It is widely hoped that statistical models can improve decision-making related to medical treatments. Because of the cost and scarcity of medical outcomes data, this hope is typically based on investigators observing a model's success in one or two datasets or clinical contexts. We scrutinized this optimism by examining how well a machine learning model performed across several independent clinical trials of antipsychotic medication for schizophrenia. Models predicted patient outcomes with high accuracy within the trial in which the model was developed but performed no better than chance when applied out-of-sample. Pooling data across trials to predict outcomes in the trial left out did not improve predictions. These results suggest that models predicting treatment outcomes in schizophrenia are highly context-dependent and may have limited generalizability.


Subject(s)
Antipsychotic Agents , Machine Learning , Schizophrenia , Humans , Antipsychotic Agents/therapeutic use , Models, Statistical , Prognosis , Schizophrenia/drug therapy , Treatment Outcome , Male , Female , Child , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over
9.
Front Neuroendocrinol ; 73: 101119, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38184208

ABSTRACT

Rates of alcohol use disorder (AUD) are increasing in men and women and there are high rates of concurrent posttraumatic stress disorder (PTSD) and AUD. AUD and PTSD synergistically increase symptomatology and negatively affect treatment outcomes; however, there are very limited pharmacological treatments for PTSD/AUD. Neurosteroids have been implicated in the underlying neurobiological mechanisms of both PTSD and AUD and may be a target for treatment development. This review details the past ten years of research on pregnenolone, progesterone, allopregnanolone, pregnanolone, estradiol, testosterone and dehydroepiandrosterone/dehydroepiandrosterone-sulfate (DHEA/DHEA-S) in the context of PTSD and AUD, including examination of trauma/alcohol-related variables, such as stress-reactivity. Emerging evidence that exogenous pregnenolone, progesterone, and allopregnanolone may be promising, novel interventions is also discussed. Specific emphasis is placed on examining the application of sex as a biological variable in this body of literature, given that women are more susceptible to both PTSD diagnoses and stress-related alcohol consumption.


Subject(s)
Alcoholism , Neurosteroids , Stress Disorders, Post-Traumatic , Humans , Stress Disorders, Post-Traumatic/metabolism , Stress Disorders, Post-Traumatic/drug therapy , Neurosteroids/metabolism , Alcoholism/metabolism , Alcoholism/drug therapy , Animals , Female , Male
10.
J Thorac Oncol ; 19(4): 643-649, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37977486

ABSTRACT

INTRODUCTION: To determine whether personalized gain-framed messaging and biomarker feedback related to tobacco cessation or reduction decrease smoking behavior in patients undergoing or eligible for lung cancer screening. METHODS: Between 2016 and 2020, 188 patients were enrolled in a two-phase, sequential, randomized controlled trial. Phase 1 evaluated whether standard of care (SC) (five in-person counseling sessions and 8 weeks of nicotine patch) plus gain-framed messaging (GFM) versus SC would increase 8-week biochemically verified smoking cessation rates. In 143 participants randomized in phase 2, we tested whether feedback on smoking-related biomarkers would reduce 6-month self-reported number of cigarettes smoked per day compared with a no feedback control. Chi-square test and mixed effects repeated measures analyses were used to evaluate group differences. RESULTS: Participants were 62.5 ± 5.6 (mean ± SD) years of age, had a 50.3 ± 21 pack-year smoking history, and were smoking 16.9 ± 9.9 cigarettes per day. At 8 weeks, there was no difference in quit rates between those randomized to SC plus GFM (n = 15 of 93, 16.1%) and those randomized to SC (n = 16 of 95, 16.8%), with p equals to 0.90. At the 6-month post-randomization follow-up, number of cigarettes smoked per day was similar in the feedback (least-squares mean = 7.5, 95% confidence interval: 6.0-9.1) and no feedback arms (7.7, 95% confidence interval: 6.2-9.3), with p equals to 0.87. CONCLUSIONS: Gain-framed messaging and health feedback did not significantly improve quit rates relative to comprehensive standard of care. Nevertheless, the overall program achieved clinically meaningful smoking quit rates in this older high pack-year cohort, highlighting the importance of intensive tobacco treatment for patients undergoing lung cancer screening. CLINICAL TRIAL REGISTERED WITH CLINICALTRIALS.GOV: NCT02658032.


Subject(s)
Lung Neoplasms , Smoking Cessation , Humans , Early Detection of Cancer , Lung Neoplasms/diagnosis , Smoking/adverse effects , Nicotiana
11.
Nicotine Tob Res ; 26(3): 324-332, 2024 Feb 22.
Article in English | MEDLINE | ID: mdl-37565294

ABSTRACT

INTRODUCTION: Childhood trauma is known to be associated with nicotine dependence, yet limited smoking outcomes have been examined and few studies have assessed associations between specific trauma subscales and smoking. Additionally, sex differences in trauma-smoking relations are understudied. This study examined associations between childhood trauma and several smoking-related outcomes in adults who smoke after overnight abstinence. AIMS AND METHODS: People who smoke (N = 205) completed self-report and biochemical assessments evaluating childhood trauma, affect, nicotine dependence, smoking urges, withdrawal, and plasma cortisol and cotinine levels. Smoking outcomes were compared between those with and without a history of moderate to severe childhood trauma among the total sample and by sex. RESULTS: Relative to those with no to minimal abuse, those with moderate to severe abuse had higher negative affect, withdrawal severity, and plasma cotinine levels. Exploratory analyses revealed that women were more likely than men to have urges to smoke for negative reinforcement and have higher withdrawal severity, but no interactions between abuse group and sex were observed. Examining specific trauma subscales, the moderate to severe emotional abuse group had more severe nicotine dependence, negative affect, and withdrawal compared to the no to minimal group. The moderate to severe sexual abuse group had more severe nicotine dependence and withdrawal compared to the no to minimal group. CONCLUSIONS: Exposure to childhood trauma is associated with more severe nicotine dependence, negative affect, withdrawal, and higher plasma cotinine levels. Findings also indicate that different types of trauma may differentially affect smoking behaviors. IMPLICATIONS: This study of adults who smoke finds that childhood trauma history may be a marker for smoking susceptibility and suggests that individuals with experiences of emotional and sexual abuse may require targeted forms of smoking cessation interventions. Moreover, findings suggest that smoking risks may differ for men and women. Findings inform public health interventions intended to reduce cigarette use in individuals with exposure to childhood trauma.


Subject(s)
Adverse Childhood Experiences , Smoking Cessation , Substance Withdrawal Syndrome , Tobacco Use Disorder , Adult , Humans , Female , Male , Child , Tobacco Use Disorder/epidemiology , Tobacco Use Disorder/psychology , Smoking Cessation/psychology , Substance Withdrawal Syndrome/psychology , Cotinine , Tobacco Use
12.
Alcohol Clin Exp Res (Hoboken) ; 48(1): 5-15, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38102794

ABSTRACT

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.

13.
J Pain Res ; 16: 4037-4047, 2023.
Article in English | MEDLINE | ID: mdl-38054108

ABSTRACT

Background: Pain assessment is performed in many healthcare systems, such as the Veterans Health Administration, but prior studies have not assessed whether pain screening varies in sexual and gender minority populations that include individuals who identify as lesbian, gay, bisexual, and/or transgender (LGBT). Objective: The purpose of this study was to evaluate pain screening and reported pain of LGBT Veterans compared to non-LGBT Veterans. Methods: Using a retrospective cross-sectional cohort, data from the Corporate Data Warehouse, a national repository with clinical/administrative data, were analyzed. Veterans were classified as LGBT using natural language processing. We used a robust Poisson model to examine the association between LGBT status and binary outcomes of pain screening, any pain, and persistent pain within one year of entry in the cohort. All models were adjusted for demographics, mental health, substance use, musculoskeletal disorder(s), and number of clinic visits. Results: There were 1,149,486 Veterans (218,154 (19%) classified as LGBT) in our study. Among LGBT Veterans, 94% were screened for pain compared to 89% among those not classified as LGBT (non-LGBT) Veterans. In adjusted models, LGBT Veterans' probability of being screened for pain compared to non-LGBT Veterans was 2.5% higher (95% CI 2.3%, 2.6%); risk of any pain was 2.1% lower (95% CI 1.6%, 2.6%); and there was no significant difference between LGBT and non-LGBT Veterans in persistent pain (RR = 1.00, 95% CI (0.99, 1.01), p = 0.88). Conclusions: In a nationwide sample, LGBT Veterans were more likely to be screened for pain but had lower self-reported pain scores, though adjusted differences were small. It was notable that transgender and Black Veterans reported the greatest pain. Reasons for these findings require further investigation.

14.
Tob Control ; 2023 Oct 28.
Article in English | MEDLINE | ID: mdl-37898544

ABSTRACT

BACKGROUND: The US Food and Drug Administration (FDA) requires a warning label on nicotine e-cigarettes and pouches: 'This product contains nicotine. Nicotine is an addictive chemical'. Some brands marketing synthetic nicotine products have modified the warning ('This product contains tobacco-free nicotine (TFN)…'). The public health impact of altering the warning is unknown, so we examined its impact on risk perceptions and use intentions. METHODS: 1000 participants completed an anonymous online survey. Participants viewed the black-and-white FDA and TFN-modified warning labels in isolation, in a randomised order and reported on perceived addictiveness and, secondarily, use intentions. Participants then selected which label conveyed the most harm overall. Generalised estimating equations (GEEs) were used to evaluate the impact of label type and participant characteristics on perceived addictiveness and, secondarily, use intentions. Multivariable logistic regression was used to evaluate relationships between participant characteristics and choosing which label conveyed the most harm. RESULTS: Overall, the TFN-modified label was associated with lower addictiveness ratings but not increased use intentions. Where significant interactions between label type and participant characteristics emerged, TFN-modified labelling was associated with disproportionately reduced risk perceptions or increased use intentions among vulnerable populations (eg, underage individuals, racially minoritised groups). 25.5% of participants selected the TFN-modified label as conveying the most harm, with younger individuals (<21 years) significantly less likely to choose the TFN-modified label. CONCLUSIONS: Modifying the FDA-mandated nicotine warning label to include 'tobacco-free nicotine' may negatively impact public health, so the FDA should enforce inclusion of its original required warning label.

15.
Psychol Addict Behav ; 37(7): 829-840, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37535555

ABSTRACT

OBJECTIVE: Craving predicts smoking, yet existing interventions may not adequately target regulation of craving. We evaluated two versions of regulation of craving-training (ROC-T), a computerized intervention with intensive practice of strategies when exposed to smoking-related images. METHOD: Ninety-two nicotine-dependent daily smokers were randomized to mindfulness-based therapy (MBT) ROC-T focusing on mindful acceptance, and cognitive behavioral therapy (CBT) ROC-T focusing on reappraisal or no intervention control. The ROC task was administered pre- and postintervention to assess changes in cue-induced craving and mindfulness- and reappraisal-based regulation of craving. RESULTS: MBT and CBT-versus control-showed significantly greater reductions in smoking during the intervention phase (baseline to Week 4), corresponding to large (d = -1.08, 95% CI [-1.64, -0.52]) and medium-to-large effect sizes (d = -0.69, 95% CI [-1.22, -0.15]), respectively. During follow-up (Week 4-16), CBT showed significant increases in smoking, whereas MBT and control did not. For the entire study (baseline to Week 16), MBT showed significantly greater reductions in smoking compared to control (d = -1.6, 95% CI [-2.56, -0.66]) but CBT was not significantly different than control (d = -0.82, 95% CI [-1.77, 0.13]). There were no effects on smoking when directly comparing MBT and CBT. Quit rates were low across the sample, with no difference among conditions. MBT and CBT-versus control-significantly reduced cue-induced craving. CBT (but not MBT)-versus control-significantly improved reappraisal-based regulation of craving. Both MBT and CBT-versus control-significantly improved mindfulness-based regulation of craving. CONCLUSIONS: MBT- and CBT-ROC-T may reduce cue-induced craving and smoking, and MBT may be more durable than CBT. (PsycInfo Database Record (c) 2023 APA, all rights reserved).


Subject(s)
Mindfulness , Smoking Cessation , Tobacco Products , Humans , Craving/physiology , Mindfulness/methods , Smokers , Smoking Cessation/psychology
16.
J Womens Health (Larchmt) ; 32(8): 852-857, 2023 08.
Article in English | MEDLINE | ID: mdl-37585509

ABSTRACT

There is a critical need for interdisciplinary and translational scientists to apply sex as a biological variable (SABV) research to address knowledge gaps in the health of women. In 2018, the Office of Research on Women's Health (ORWH) partnered with several National Institute of Health (NIH) Institutes and Centers to expand the Specialized Centers of Research (SCOR) Excellence (SCORE) Programs (together referred to as SCOR/E) with an important feature-the Career Enhancement Core (CEC). The SCORE CEC mentors early career investigators to become the next generation of biomedical and behavioral researchers focused on SABV and women's health. In this article, we outline our approach at the Yale University SCORE to support early career trajectories through the provision of salary support, educational curricula, translational mentorship, pilot project funding, and professional development. Using the Yale-SCOR/E CEC Programs as instructional models, we highlight critical measures of academic success, namely grant funding and publications, among early career investigators. At Yale University, 12 pilot projects funded by the SCOR/E Programs resulted in 14 extramural grants, amounting to an $80 return on every $1 invested in "seed" funding. So far, our SCOR/E Programs have resulted in 129 publications, 83% of which were first-authored by trainees, and 100% of trainees continued research careers with an emphasis on SABV. Finally, we provide recommendations on how biomedical scientists can apply SABV in their studies of major medical conditions in an interdisciplinary and integrative way.


Subject(s)
Biomedical Research , Women's Health , Humans , Female , United States , Pilot Projects , Curriculum , Mentors , Financing, Organized , National Institutes of Health (U.S.)
17.
Drug Alcohol Depend ; 250: 110898, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37523916

ABSTRACT

BACKGROUND: Our group has established the feasibility of using on-body electrocardiographic (ECG) sensors to detect cocaine use in the human laboratory. The purpose of the current study was to test whether ECG sensors and features are capable of discriminating cocaine use from other non-cocaine sympathomimetics. METHODS: Eleven subjects with cocaine use disorder wore the Zephyr BioHarness™ 3 chest band under six experimental (drug and non-drug) conditions, including 1) laboratory, intravenous cocaine self-administration, 2) after a single oral dose of methylphenidate, 3) during aerobic exercise, 4) during tobacco use (N=7 who smoked tobacco), and 5) during routine activities of daily inpatient living (unit activity). Three ECG-derived feature sets served as primary outcome measures, including 1) the RR interval (i.e., heart rate), 2) a group of ECG interval proxies (i.e., PR, QS, QT and QTc intervals), and 3) the full ECG waveform. Discriminatory power between cocaine and non-cocaine conditions for each of the three outcomes measures was expressed as the area under the receiver operating characteristics (AUROC) curve. RESULTS: All three outcomes successfully discriminated cocaine use from unit activity, exercise, tobacco, and methylphenidate conditions with a mean AUROC values ranging from 0.66 to 0.99 and with least squares means values all statistically different/higher than 0.5 among all subjects [F(3, 99) = 3.38, p =0.02] and among those with tobacco use [F(4, 84) = 5.39, p = 0.0007]. CONCLUSIONS: These preliminary results support discriminatory power of wearable ECG sensors for detecting cocaine use.


Subject(s)
Cocaine-Related Disorders , Cocaine , Methylphenidate , Wearable Electronic Devices , Humans , Sympathomimetics , Electrocardiography , Cocaine-Related Disorders/diagnosis
18.
J Behav Addict ; 12(2): 490-499, 2023 Jun 29.
Article in English | MEDLINE | ID: mdl-37335777

ABSTRACT

Background and aims: Gambling in adolescents is a public health concern. This study sought to examine patterns of gambling among Connecticut high-school students using seven representative samples covering a 12-year period. Methods: Data were analyzed from N = 14,401 participants in cross-sectional surveys conducted every two years based on random sampling from schools in the state of Connecticut. Anonymous self-completed questionnaires included socio-demographic data, current substance use, social support, and traumatic experiences at school. Chi-square tests were used to compare socio-demographic characteristics between gambling and non-gambling groups. Logistic regressions were used to assess changes in the prevalence of gambling over time and effects of potential risk factors on the prevalence, adjusted for age, sex, and race. Results: Overall, the prevalence of gambling largely decreased from 2007 to 2019, although the pattern was not linear. After steadily declining from 2007 to 2017, 2019 was associated with increased rates of gambling participation. Consistent statistical predictors of gambling were male gender, older age, alcohol and marijuana use, higher levels of traumatic experiences at school, depression, and low levels of social support. Discussion and conclusion: Among adolescents, older males may be particularly vulnerable to gambling that relates importantly to substance use, trauma, affective concerns, and poor support. Although gambling participation appears to have declined, the recent increase in 2019 that coincides with increased sports gambling advertisements, media coverage and availability warrants further study. Our findings suggest the importance of developing school-based social support programs that may help reduce adolescent gambling.


Subject(s)
Adolescent Behavior , Gambling , Substance-Related Disorders , Humans , Male , Adolescent , Female , Connecticut/epidemiology , Protective Factors , Cross-Sectional Studies , Gambling/psychology , Risk Factors , Substance-Related Disorders/epidemiology , Adolescent Behavior/psychology
19.
Psychol Med ; 53(16): 7775-7784, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37366017

ABSTRACT

BACKGROUND: Certain treatments have demonstrated acute efficacy for binge-eating disorder (BED) but there is a dearth of controlled research examining pharmacotherapies as maintenance treatments for responders to initial interventions. This gap in the literature is particularly critical for pharmacotherapy for BED which is associated with relapse following discontinuation. The current study tested the efficacy of naltrexone/bupropion maintenance treatment amongst responders to acute treatments for BED. METHODS: Prospective randomized double-blind placebo-controlled single-site trial, conducted August 2017-December 2021, tested naltrexone/bupropion as maintenance treatment for responders to acute treatments with naltrexone/bupropion and/or behavioral weight-loss therapy for BED with comorbid obesity. Sixty-six patients (84.8% women, mean age 46.9, mean BMI 34.9 kg/m2) who responded to acute treatments were re-randomized to placebo (N = 34) or naltrexone/bupropion (N = 32) for 16 weeks; 86.3% completed posttreatment assessments. Mixed models and generalized estimating equations comparing maintenance treatments (naltrexone/bupropion v. placebo) included main and interactive effects of acute treatments. RESULTS: Intention-to-treat binge-eating remission rates following maintenance treatments were 50.0% (N = 17/34) for placebo and 68.8% (N = 22/32) for naltrexone/bupropion. Placebo following response to acute treatment with naltrexone/bupropion was associated with significantly decreased probability of binge-eating remission, increased binge-eating frequency, and no weight loss. Naltrexone/bupropion following response to acute treatment with naltrexone/bupropion was associated with good maintenance of binge-eating remission, low binge-eating frequency, and significant additional weight loss. CONCLUSIONS: Adult patients with BED with co-occurring obesity who have good responses to acute treatment with naltrexone/bupropion should be offered maintenance treatment with naltrexone/bupropion.


Subject(s)
Binge-Eating Disorder , Bulimia , Adult , Humans , Female , Middle Aged , Male , Bupropion/therapeutic use , Naltrexone/therapeutic use , Binge-Eating Disorder/drug therapy , Prospective Studies , Treatment Outcome , Obesity/complications , Bulimia/drug therapy , Weight Loss , Double-Blind Method
20.
Front Behav Neurosci ; 17: 1192740, 2023.
Article in English | MEDLINE | ID: mdl-37358969

ABSTRACT

Introduction: Sex differences exist in tobacco smoking. Women have greater difficulty quitting smoking than men. Tobacco smoking is driven by the reinforcing effects of nicotine, the primary addictive component in cigarettes. Nicotine binds to nicotinic acetylcholine receptors, facilitating dopamine release in striatal and cortical brain regions. Dysregulated dopamine D2/3 receptor signaling in the dorsolateral prefrontal cortex (dlPFC) is associated with cognitive deficits such as impairments in attention, learning, and inhibitory control that impede quit attempts. Sex steroid hormones, such as estradiol and progesterone, influence drug-taking behaviors, through dopaminergic actions, suggesting that their influence may explain sex differences in tobacco smoking. The goal of this study was to relate dlPFC dopamine metrics to sex steroid hormone levels in people who smoke and healthy controls. Methods: Twenty-four (12 women) people who smoke cigarettes and 25 sex- and age-matched controls participated in two same-day [11C]FLB457 positron emission tomography scans, one before and one after amphetamine administration. D2R availability (BPND) at baseline and after amphetamine administration was calculated. On the same day, plasma samples were collected for the analysis of sex steroid hormone levels: estradiol, progesterone, and free testosterone. Results: Women who smoke had trending lower levels of estradiol than their sex-matched counterparts. Men who smoke had higher levels of estradiol and trending higher levels of free testosterone than their sex-matched counterparts. Among women only, lower estradiol levels were significantly associated with lower pre-amphetamine dlPFC BPND. Discussion/conclusion: This study demonstrated that lower estradiol levels are associated with lower dlPFC D2R availability in women which may underlie difficulty resisting smoking.

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