Reduced Nicotine Cigarettes and E-Cigarettes in High-Risk Populations: 3 Randomized Clinical Trials.

Importance: Prohibiting the sale of commonly preferred e-cigarette flavors (eg, fruity and sweet) to discourage use among youths poses a risk of diminishing efforts to decrease smoking in adults. Objective: To compare reductions in smoking achieved in adults with psychiatric conditions or lower educational level using very low nicotine content (VLNC) cigarettes alone, combined with e-cigarettes limited to tobacco flavor (TF), or combined with e-cigarettes in participant-preferred flavors. Design, Setting, and Participants: Three randomized clinical trials were conducted for 16 weeks from October 2020 through November 2023 at the University of Vermont, Brown University, and Johns Hopkins University. Participants were adults who smoked daily and were not planning to quit in the next 30 days. These participants were from 3 at-risk populations: those with affective disorders, exemplifying mental illness; those with opioid use disorder, exemplifying substance use disorders; and females of reproductive age with a high-school education or less, exemplifying lower educational level. Participants were randomly assigned to 1 of 4 experimental conditions: (1) normal nicotine content (NNC) cigarettes only; (2) VLNC cigarettes only; (3) VLNC cigarettes plus e-cigarettes with classic TF (hereafter, VLNC + TF); and (4) VLNC cigarettes plus e-cigarettes with preferred flavors (hereafter, VLNC + PF). Interventions: The NNC cigarettes contained 15.8 mg nicotine/g tobacco, the VLNC cigarettes contained 0.4 mg nicotine/g tobacco, the VLNC + TF had pods containing 5% nicotine by weight and only classic TF, and the VLNC + PF had pods containing 5% nicotine in 8 flavors (including fruity and sweet) from which participants selected 3 flavors. Main Outcomes and Measures: The primary outcome was mean total cigarettes smoked per day (CPD) during week 16. Tobacco-related biomarkers were assessed, including total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a tobacco-specific carcinogen. Results: A total of 326 participants (mean [SD] age, 40.09 [10.79] years; 243 females [74.5%]) from 3 randomized clinical trials were included. The VLNC cigarettes decreased total CPD, with least square (LS) means (SEMs) of 22.54 (1.59) in the NNC, 14.32 (1.32) in the VLNC, 11.76 (1.18) in the VLNC + TF, and 7.63 (0.90) in the VLNC + PF conditions. Each VLNC condition differed significantly from NNC, with an adjusted mean difference (AMD) of -8.21 (95% CI, -12.27 to -4.16; P < .001) in the VLNC, -10.78 (95% CI, -14.67 to -6.90; P < .001) in the VLNC + TF, and -14.91 (95% CI, -18.49 to -11.33; P < .001) in the VLNC + PF conditions. Participants in the VLNC + PF condition also decreased smoking below the VLNC and the VLNC + TF conditions (AMDs, -6.70 [95% CI, -9.84 to -3.55; P < .001] and -4.13 [95% CI, -7.05 to -1.21; P = .02]); the VLNC and VLNC + TF conditions did not differ significantly. Consistent with decreases in CPD, NNAL levels in the VLNC + PF condition were lower than in all other conditions, with AMDs (in pmol/mg creatinine) of -0.94 (95% CI, -1.41 to -0.47; P < .001) compared with the NNC condition, -0.47 (95% CI, -0.87 to -0.08; P = .03) compared with the VLNC condition, and -0.46 (95% CI, -0.83 to -0.10; P = .04) compared with the VLNC + TF condition. Conclusions and Relevance: These results provide further evidence that a reduced-nicotine standard for cigarettes has the potential to decrease smoking and tobacco-toxicant exposure in high-risk populations and that these effects may be enhanced when adults can access e-cigarettes in commonly preferred flavors. Trial Registration: ClinicalTrials.gov Identifiers: NCT04092387, NCT04090879, NCT04092101.

Systematic review of randomised controlled clinical trials examining effectiveness of contingent financial rewards for smoking cessation during pregnancy: intention-to-treat and causal effects on birthweight.

BACKGROUND: Objective: To examine birth weight change caused by adding financial rewards for smoking cessation compared to no rewards for pregnant women. To estimate the average expected birth weight change for those who quit because of rewards. METHODS: This study updates a previous systematic review and refocuses the outcome from smoking cessation to birth weight.Eligibility Criteria: Trials with an experimental design allowing treatment effects to be attributed to rewards were included. Trials involving non-pregnant participants, or with no report of magnitude, treatment duration, timing or where most rewards were contingent on another behaviour (e.g., treatment attendance) were excluded.Information sources: Medline, PsycInfo, Embase, Cochrane (Central Register of Controlled Trials, Tobacco Addiction Group Specialised Register and Database of Systematic Reviews), and PubMed searched to 5th December 2023.Risk of bias: Risk of bias and certainty of evidence used Cochrane 'Risk of bias 2' and GRADE assessments.Synthesis of results: Primary analysis estimated Intention-To-Treat (ITT) mean birthweight difference when randomised to offer of rewards versus control. Within-trial estimates and standard errors were derived from mean, standard deviation, and sample size data provided, or from publications. Pooled ITT estimates used common (fixed) and random effects models. Secondary analyses used trial team supplied data to derive Complier Average Causal Effect (CACE) estimate of smoking cessation on birth weight, and a standard error. Estimates were pooled using common and random effects models. Similar analyses were applied to low birth weight (<2500g), birth weight for gestational age z-scores, and small for gestational age (<10 th percentile). RESULTS: Included studies: Primary analysis included 8 trials (2351 participants) from the UK (2 trials, 1475 participants); France (1 trial, 407 participants), and the US (6 trials, 469 participants). Secondary analysis included 7 trials as data retrieval from one US trial (51 participants) was not possible.Synthesis of results: Primary ITT analysis (2351 participants) estimated a mean 46.3g (95% CI: 0.0 to 92.6) birth weight increase when offered financial rewards for smoking cessation. Secondary CACE analysis (2239 participants) estimated a mean 206.0g (95% CI: -69.1 to 481.1) increase for smokers who quit because of rewards. There was no effect on low birth weight (<2500g), or birth weight adjusted for gestational age, though less babies were born small for gestational age, particularly if cessation was because of rewards (CACE risk difference -17.7%; 95% CI: -34.9% to -0.4%). DISCUSSION: Limitation of evidence: Sample size led to imprecision - maximum 2351 participants. A single trial of 3712 participants would give 80% power at 5% significance to show a 46g increase from 3.1kg to 3.146kg with 0.5kg standard deviation in both groups. Consistency - trials where smoking cessation increased (7 of 8) all showed a mean birth weight increase. In one trial smoking cessation fell as did birth weight. Bias is unlikely as 3 of 4 trials with no birth weight data showed increased cessation consistent with higher mean birth weight. Interpretation: Trials of contingent financial rewards for smoking cessation have previously been shown to more than double pregnancy quit rates. We have uncovered a significant (46g) population level increase in mean birth weight, driven by a clinically important mean increase (206g) for those who quit because of financial rewards associated with a reduction in Small for Gestational Age births. OTHER: Funding: Review update - The U.S. National Institute of Health, National Institute of General Medical Sciences Center of Biomedical Research Excellence Award P30GM149331. Data retrieval, synthesis and analysis - Scottish Cot Death Trust.Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024494262.

Reprint of: Clustering of behavioral economic biases in decision-making and risk for cigarette smoking and other substance use in women and men.

BACKGROUND: Low loss aversion (LA) and high delay discounting (DD) are behavioral-economic decision-making biases that independently predict cigarette smoking and other risky substance use. Here we examine (1) whether low-LA and high-DD co-occur, (2) does co-occurrence increase the odds of current smoking and other substance use compared to only low-LA, high-DD, or neither; and (3) potential gender differences in these associations. METHOD: Data are from five studies with U.S. adults who currently smoked or never-smoked cigarettes recruited using online convenience sampling matching on gender and education. Participants completed identical sociodemographic, substance use (cigarette, other drugs, alcohol), and LA (hypothetical 50-50 gambles) and DD (monetary-choice questionnaire) measures. LA and DD scores were dichotomized as low and high using Receiver-Operating-Characteristic Curve logistic regression. RESULTS: LA and DD each independently predicted substance use and with few exceptions were not influenced by gender. Low-LA compared to high-LA predicted two-fold greater odds of co-occurring high-DD (AOR = 2.120, 95%CI:1.749-2.571, p < .0001). Similarly, high-DD compared to low DD predicted two-fold greater odds of low-LA (AOR = 2.118, 95%CI:1.747-2.568, p < .0001). Among those with co-occurring low-LA and high-DD, odds of substance use were 5-10 times greater than those exhibiting neither, and 2-3 times greater than those exhibiting only low-LA or high-DD. CONCLUSIONS: Low-LA and high-DD cluster in women and men such that exhibiting one of these decision-making biases doubles the odds of exhibiting the other. These results demonstrate reliable clustering of low-LA and high-DD and a striking increase in risk for substance use relative to having only one or neither decision-making bias.

Validity and reliability of the cigarette purchase task when participant cigarette consumption is unconstrained.

Hypothetical purchase tasks offer effective and efficient methods to assess the reinforcing value of various substances, including cigarettes. The purpose of the present study is to examine the validity and reliability of the Cigarette Purchase Task (CPT) in an experimental arrangement in which participants were receiving free cigarettes. Critical to the validity of the CPT is that those who smoke can accurately estimate how much they would smoke under varying economic constraints. Participants (N = 9) were provided free study cigarettes for 8 weeks. Participants completed the CPT once weekly. To examine the validity of the five CPT demand indices (i.e., demand intensity, Pmax, Omax, breakpoint, and α), we used a simple linear regression stratified by session number to model which of the five CPT demand indices were associated with the number of cigarettes smoked per day during Week 1 of the experiment. Significant associations in the hypothesized direction were noted across the five CPT indices, with the evidence for validity greatest for intensity, followed by Omax, Pmax, breakpoint, and α. To examine CPT test-retest reliability, we estimated interclass correlation coefficients between Sessions 1 and 4 and Sessions 5 and 8. All but one interclass correlation coefficient supported "good" or "excellent" reliability, with the only exception seen with the α index between Sessions 1 and 4, which was moderate reliability. Collectively, these results provide evidence supporting the construct validity and temporal stability/reliability of the CPT demand indices under conditions of limited economic constraint. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Sex differences in tobacco use, attempts to quit smoking, and cessation among dual users of cigarettes and e-cigarettes: Longitudinal findings from the US Population Assessment of Tobacco and Health Study.

SIGNIFICANCE: A growing number of adults use more than one tobacco product, with dual use of cigarettes and e-cigarettes being the most common combination. Monitoring sex disparities in tobacco use is a public health priority. However, little is known regarding whether dual users differ by sex. METHODS: Data came from Waves 4-6 (12/2016-11/2021) of the Population Assessment of Tobacco and Health Study, a US nationally-representative longitudinal survey. This analysis included current adult dual users of cigarettes and e-cigarettes. We used weighted generalized estimating equations to assess the association between sex and (1) making a cigarette quit attempt (n = 1882 observations from n = 1526 individuals) and (2) smoking cessation (n = 2081 observations from n = 1688 individuals) across two wave pairs, adjusting for age, education, ethnicity, time-to-first cigarette after waking, and e-cigarette use frequency. RESULTS: Among US dual users, 14.1% (95% Confidence Intervals [Cl] = 11.9-16.4) of females and 23.4% (20.0-26.9) of males were young adults (aged 18-24), 11.7% (9.2-14.2) of females and 14.4% (11.6-17.2) of males had

Reprint of: Examining U.S. disparities in smoking among rural versus urban women of reproductive age: 2002-2019.

OBJECTIVE: This study is part of a programmatic investigation of rural disparities in cigarette smoking examining disparities in smoking prevalence and for the first-time quit ratios among adult women of reproductive age (18-44 years), a highly vulnerable population due to risk for multigenerational adverse effects. METHODS: Data came from 18 years (2002-2019) of the U.S. National Survey on Drug Use and Health (NSDUH) among women (n = 280,626) categorized by rural-urban residence, pregnancy status, using weighted logistic regression models testing time trends and controlling for well-established sociodemographic predictors of smoking (race/ethnicity, education, income). Concerns regarding changes in survey methods used before 2002 and after 2019 precluded inclusion of earlier and more recent survey years in the present study. RESULTS: Overall smoking prevalence across years was greater in rural than urban residents (adjusted odds ratio [AOR] = 1.11; 95%CI, 1.07-1.15; P < .001) including those not-pregnant (AOR = 1.10; 1.07-1.14; P < .001) and pregnant (AOR = 1.29; 1.09-1.52; P < .001). Overall quit ratios across years were lower in rural than urban residents (AOR = 0.93; 0.87-0.99; P < .001) including those not-pregnant (AOR = 0.93; 0.88-1.00, P = .035) and pregnant (AOR = 0.78; 0.62-0.99; P = .039). Interactions of rural versus urban residence with study years for prevalence and quit ratios overall and by pregnancy status are detailed in the main text. CONCLUSIONS: These results support a longstanding and robust rural disparity in smoking prevalence among women of reproductive age including those currently pregnant and provides novel evidence that differences in smoking cessation contribute to this disparity further underscoring a need for greater access to evidence-based tobacco control and regulatory interventions in rural regions.

Clustering of behavioral economic biases in decision-making and risk for cigarette smoking and other substance use in women and men.

BACKGROUND: Low loss aversion (LA) and high delay discounting (DD) are behavioral-economic decision-making biases that independently predict cigarette smoking and other risky substance use. Here we examine (1) whether low-LA and high-DD co-occur, (2) does co-occurrence increase the odds of current smoking and other substance use compared to only low-LA, high-DD, or neither; and (3) potential gender differences in these associations. METHOD: Data are from five studies with U.S. adults who currently smoked or never-smoked cigarettes recruited using online convenience sampling matching on gender and education. Participants completed identical sociodemographic, substance use (cigarette, other drugs, alcohol), and LA (hypothetical 50-50 gambles) and DD (monetary-choice questionnaire) measures. LA and DD scores were dichotomized as low and high using Receiver-Operating-Characteristic Curve logistic regression. RESULTS: LA and DD each independently predicted substance use and with few exceptions were not influenced by gender. Low-LA compared to high-LA predicted two-fold greater odds of co-occurring high-DD (AOR = 2.120, 95%CI:1.749-2.571, p < .0001). Similarly, high-DD compared to low DD predicted two-fold greater odds of low-LA (AOR = 2.118, 95%CI:1.747-2.568, p < .0001). Among those with co-occurring low-LA and high-DD, odds of substance use were 5-10 times greater than those exhibiting neither, and 2-3 times greater than those exhibiting only low-LA or high-DD. CONCLUSIONS: Low-LA and high-DD cluster in women and men such that exhibiting one of these decision-making biases doubles the odds of exhibiting the other. These results demonstrate reliable clustering of low-LA and high-DD and a striking increase in risk for substance use relative to having only one or neither decision-making bias.

Sex differences in tobacco use, attempts to quit smoking, and cessation among dual users of cigarettes and e-cigarettes: Longitudinal findings from the US Population Assessment of Tobacco and Health Study.

SIGNIFICANCE: A growing number of adults use more than one tobacco product, with dual use of cigarettes and e-cigarettes being the most common combination. Monitoring sex disparities in tobacco use is a public health priority. However, little is known regarding whether dual users differ by sex. METHODS: Data came from Waves 4-6 (12/2016-11/2021) of the Population Assessment of Tobacco and Health Study, a US nationally-representative longitudinal survey. This analysis included current adult dual users of cigarettes and e-cigarettes. We used weighted generalized estimating equations to assess the association between sex and (1) making a cigarette quit attempt (n = 1882 observations from n = 1526 individuals) and (2) smoking cessation (n = 2081 observations from n = 1688 individuals) across two wave pairs, adjusting for age, education, ethnicity, time-to-first cigarette after waking, and e-cigarette use frequency. RESULTS: Among US dual users, 14.1% (95% Confidence Intervals [Cl] = 11.9-16.4) of females and 23.4% (20.0-26.9) of males were young adults (aged 18-24), 11.7% (9.2-14.2) of females and 14.4% (11.6-17.2) of males had

Examining U.S. disparities in smoking among rural versus urban women of reproductive age: 2002-2019.

OBJECTIVE: This study is part of a programmatic investigation of rural disparities in cigarette smoking examining disparities in smoking prevalence and for the first-time quit ratios among adult women of reproductive age (18-44 years), a highly vulnerable population due to risk for multigenerational adverse effects. METHODS: Data came from 18 years (2002-2019) of the U.S. National Survey on Drug Use and Health (NSDUH) among women (n = 280,626) categorized by rural-urban residence, pregnancy status, using weighted logistic regression models testing time trends and controlling for well-established sociodemographic predictors of smoking (race/ethnicity, education, income). Concerns regarding changes in survey methods used before 2002 and after 2019 precluded inclusion of earlier and more recent survey years in the present study. RESULTS: Overall smoking prevalence across years was greater in rural than urban residents (adjusted odds ratio [AOR] = 1.11; 95%CI, 1.07-1.15; P < .001) including those not-pregnant (AOR = 1.10; 1.07-1.14; P < .001) and pregnant (AOR = 1.29; 1.09-1.52; P < .001). Overall quit ratios across years were lower in rural than urban residents (AOR = 0.93; 0.87-0.99; P < .001) including those not-pregnant (AOR = 0.93; 0.88-1.00, P = .035) and pregnant (AOR = 0.78; 0.62-0.99; P = .039). Interactions of rural versus urban residence with study years for prevalence and quit ratios overall and by pregnancy status are detailed in the main text. CONCLUSIONS: These results support a longstanding and robust rural disparity in smoking prevalence among women of reproductive age including those currently pregnant and provides novel evidence that differences in smoking cessation contribute to this disparity further underscoring a need for greater access to evidence-based tobacco control and regulatory interventions in rural regions.

Moral injury among women military veterans and demand for cigarettes: A behavioral economic investigation using a hypothetical purchase task.

OBJECTIVES: Unlike the United States general population, veteran women - as opposed to veteran men - have greater smoking prevalence; yet, little is known regarding factors that influence smoking in veteran women. The purpose of this study was to begin examining the relationship between a psychological concept known as moral injury and demand for cigarettes among veteran women. METHODS: Veteran women who smoke (n = 44) were recruited for this cross-sectional study from Amazon MTurk, Reddit, and a veteran-serving non-profit organization in June-July 2023. Consenting participants received $2 for completing the cigarette purchase task (CPT), Fagerstrom Test for Nicotine Dependence (FTND), and the military version of the Moral Injury Symptom Scale (MISS-M-SF). We examined five CPT demand indices and calculated a modified exponential demand model stratified by moral injury severity status (i.e., probable vs. unlikely). RESULTS: Probable morally injured women exhibited significantly higher relative reinforcing value (RRV) for smoking than unlikely morally injured women (F1, 920 = 9.16, p = 0.003). Average cigarette consumption at $0 (i.e., Q0) was 48.56% higher (M = 22.24 vs. M = 13.55) in probable compared to unlikely morally injured women (p = 0.04, Hedge's g = 0.74). FTND scores were significantly correlated with Pmax (i.e., demand elasticity point) and Omax (i.e., maximum expenditure) values in both populations (rs = 0.42-0.68, ps < 0.05). CONCLUSIONS: We provide preliminary evidence of the relatively high RRV of smoking in morally injured veteran women. Continued research is needed to refine the characterization of this relationship.

Electronic nicotine delivery systems (ENDS): Frequency of use and smoking-cessation efforts among U.S. women of reproductive age.

OBJECTIVE: Reducing harm from combustible cigarette use among women of reproductive age (WRA) is critical given their potential vulnerability to multigenerational adverse impacts of cigarette smoking. Although electronic nicotine delivery systems (ENDS) are not approved smoking cessation aids in the US, many WRA who smoke report using ENDS to help quit smoking. Associations between ENDS use patterns and smoking-cessation efforts among US WRA remain unclear. METHODS: Using the Population Assessment of Tobacco and Health (PATH) Study, we examined whether baseline (Wave 3 or 4) ENDS use frequency predicted (a) making a cigarette quit attempt (QA) and (b) successful quitting by follow-up (Wave 4 or 5, respectively) among WRA (N = 2834; 72.1% non-Hispanic White). RESULTS: Daily ENDS use predicted greater adjusted odds of making a QA than non-daily (AOR = 1.63, 95% CI = 1.03, 2.59) and no ENDS use (AOR = 1.97, 95% CI = 1.23, 3.14), and greater odds of successful smoking cessation than non-daily use (AOR = 2.37, 95% CI = 1.31, 4.26). Daily ENDS use did not significantly improve odds of successful smoking cessation compared to no ENDS use (AOR = 1.62, 95% CI = 0.97, 2.69). Non-daily ENDS use did not significantly improve odds of making a QA (AOR = 1.21, 95% CI = 0.94, 1.56) and hindered successful smoking cessation compared to no ENDS use (AOR = 0.68, 95% CI = 0.48, 0.98). CONCLUSIONS: These findings suggest that benefits of ENDS for smoking cessation in WRA may be greatest among those who use ENDS daily. WRA who choose to use ENDS to help quit would be well-informed by evidence that non-daily ENDS use may impede smoking cessation.

Cigarette smoking and cognitive task performance: Experimental effects of very-low nicotine-content cigarettes.

Reductions in the nicotine content of cigarettes decrease smoking rate and dependence severity, but effects on cognition are less well established. The potential impacts of very-low nicotine-content (VLNC) cigarettes on cognitive task performance must be evaluated, especially in vulnerable populations. The aim of the present study is to experimentally examine the effects of VLNC cigarettes on cognitive performance. Adults who smoked daily (n = 775) from three vulnerable populations (socioeconomically disadvantaged reproductive-age women, individuals with opioid use disorder, affective disorders) were examined. Participants were randomly assigned to normal nicotine content (NNC; 15.8 mg nicotine/g tobacco) or VLNC (2.4 mg/g or 0.4 mg/g) cigarettes for 12 weeks. Response inhibition (stop-signal task), working memory (n-back task; n of 2-n of 0), and cognitive interference (nicotine Stroop task) were assessed at baseline, 2, 6, and 12 weeks. Results were analyzed using mixed-model repeated-measures analyses of variance. Extended exposure to VLNC cigarettes produced no significant changes in any measure of cognitive performance compared to NNC cigarettes. Over weeks, response times on the n-back task decreased across doses. No significant effects were observed on the stop-signal or nicotine Stroop tasks. All three vulnerable populations performed comparably on all three cognitive tasks. Extended exposure to VLNC cigarettes produced no impairments in cognitive performance on any of the assessed tasks compared to NNC cigarettes. These findings are consistent with the larger literature detailing other consequences following exposure to VLNC cigarettes and are encouraging for the adoption of a nicotine-reduction policy. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Substance use patterns, sociodemographics, and health profiles of harm reduction service recipients in Burlington, Vermont.

BACKGROUND: Understanding current substance use practices is critical to reduce and prevent overdose deaths among individuals at increased risk including persons who use and inject drugs. Because individuals participating in harm reduction and syringe service programs are actively using drugs and vary in treatment participation, information on their current drug use and preferred drugs provides a unique window into the drug use ecology of communities that can inform future intervention services and treatment provision. METHODS: Between March and June 2023, 150 participants in a harm reduction program in Burlington, Vermont completed a survey examining sociodemographics; treatment and medication for opioid use disorder (MOUD) status; substance use; injection information; overdose information; and mental health, medical, and health information. Descriptive analyses assessed overall findings. Comparisons between primary drug subgroups (stimulants, opioids, stimulants-opioids) of past-three-month drug use and treatment participation were analyzed using chi-square and Fisher's exact test. RESULTS: Most participants reported being unhoused or unstable housing (80.7%) and unemployed (64.0%) or on disability (21.3%). The drug with the greatest proportion of participants reporting past three-month use was crack cocaine (83.3%). Fentanyl use was reported by 69.3% of participants and xylazine by 38.0% of participants. High rates of stimulant use were reported across all participants independent of whether stimulants were a participant's primary drug. Fentanyl, heroin, and xylazine use was less common in the stimulants subgroup compared to opioid-containing subgroups (p < .001). Current- and past-year MOUD treatment was reported by 58.0% and 77.3% of participants. Emergency rooms were the most common past-year medical treatment location (48.7%; M = 2.72 visits). CONCLUSIONS: Findings indicate high rates of polysubstance use and the underrecognized effects of stimulant use among people who use drugs-including its notable and increasing role in drug-overdose deaths. Crack cocaine was the most used stimulant, a geographical difference from much of the US where methamphetamine is most common. With the increasing prevalence of fentanyl-adulterated stimulants and differences in opioid use observed between subgroups, these findings highlight the importance and necessity of harm reduction interventions (e.g., drug checking services, fentanyl test strips) and effective treatment for individuals using stimulants alongside MOUD treatment.

Changes in weight among individuals with psychiatric conditions or socioeconomic disadvantage assigned to smoke very low nicotine content cigarettes.

Nicotine abstinence leads to weight gain, which could be an unintended consequence of a nicotine reduction policy. This secondary analysis used weekly assessments of weight and ratings of "increased appetite/hunger/weight gain" collected in three 12-week, randomized controlled trials evaluating the effects of cigarettes differing in nicotine dose (15.8, 2.4, or 0.4 mg/g) among individuals with affective disorders, opioid use disorder (OUD), and socioeconomically disadvantaged women. Linear mixed models tested differences by dose and time. Analyses first collapsed across populations and then separated out individuals with OUD because biomarkers suggested they used substantially more noncombusted nicotine. Across populations, weight increased significantly over time, averaging 1.03 kg (p < .001), but did not vary by dose nor was there any interaction of dose/time. "Increased appetite/hunger/weight gain" ratings increased significantly as a function of dose, with differences between low and high doses (1.95 and 1.73, respectively, p = .01), but not by time nor any interaction. In the combined group of individuals with affective disorders and socioeconomically disadvantaged women, weight and "increased appetite/hunger/weight gain" ratings increased significantly by dose, with differences between low and high doses (1.43 vs. 0.73 kg, p = .003 and 2.00 vs. 1.76, p = .02, respectively). Among individuals with OUD, there were no significant effects of any kind on either outcome. Individuals with affective disorders and socioeconomically disadvantaged women gained weight and reported more subjective appetite/weight gain when given 0.4, but not 2.4 mg/g cigarettes, despite comparable decreases in nicotine exposure. However, neither change was clinically significant, suggesting minimal short-term adverse consequences of a nicotine reduction policy. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Loss aversion predicts cigarette smoking status across levels of sociodemographic characteristics.

Loss aversion (LA) is a tendency to be more sensitive to potential losses relative to similar gains. Low LA is associated with increased risk for cigarette smoking and use of other substances. Previous studies of LA and smoking risk controlled for potentially confounding influences of sociodemographic characteristics associated with smoking risk. The present study replicates these earlier observations while also examining the generality of the association between low LA and smoking risk within different levels of each of the five sociodemographic risk factors for smoking (age, educational attainment, gender, income, race/ethnicity). Parallel analyses were conducted using delay discounting (DD) as a positive control; DD is a decision-making bias regarding the rate at which rewards lose value with increasing delay to receipt. Participants were recruited using standard crowdsourcing methods and completed a sociodemographics questionnaire, a hypothetical gamble task measure of LA, and a monetary choice measure of DD. Low LA was associated with increased risk of cigarette smoking after accounting for the influence of sociodemographic characteristics and DD. Similarly, high DD was associated with increased risk of cigarette smoking after accounting for the influence of sociodemographic characteristics and LA. Further analyses showed that associations of LA with smoking risk or DD with smoking risk generally although not always remained significant within varying levels of the sociodemographic characteristics of interest. These results provide support for low LA as a reliable risk factor for smoking that has generality within and across sociodemographic characteristics and closely parallels associations observed with DD and smoking risk. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Behavior change, health, and health disparities 2023: Contingency management for treating substance use disorders and promoting health in vulnerable populations.

This Special Issue (SI) of Preventive Medicine is the 10th in a series on behavior change, health, and health disparities. This issue focuses on Contingency Management (CM), a highly efficacious behavior-change intervention for substance use disorders (SUDs) and other behavioral health conditions wherein patients receive material incentives (e.g., vouchers exchangeable for retail items) contingent on objectively verified behavior change. Despite substantial support for its efficacy, CM remains largely unavailable in U.S. community SUD treatment facilities and other healthcare settings. This is especially concerning regarding stimulant use disorder for which CM is the only reliably efficacious intervention in controlled studies and yet is unavailable to the vast majority of those in need. This SI details recent promising developments in efforts to surmount longstanding implementation obstacles while also detailing other promising advances from meta-analyses and controlled trials examining CM's efficacy in treating other difficult-to-treat problems including smoking among pregnant women and mothers of young children as well among those as those experiencing homelessness and alcohol use disorder, the promise of digital CM, and a potential new application in promoting adherence with SUD medications.

Technology-Assisted Buprenorphine Treatment in Rural and Nonrural Settings: Two Randomized Clinical Trials.

Importance: Expansion of opioid use disorder treatment is needed, particularly in rural communities. Objective: To evaluate technology-assisted buprenorphine (TAB) efficacy (1) over a longer period than previously examined, (2) with the addition of overdose education, and (3) among individuals residing in rural communities. Design, Setting, and Participants: Two parallel, 24-week randomized clinical trials were conducted at the University of Vermont between February 1, 2018, and June 30, 2022. Participants were adults with untreated opioid use disorder from nonrural (trial 1) or rural (trial 2) communities. These trials are part of a programmatic effort to develop TAB protocols to improve treatment availability in underserved areas. Interventions: Within each trial, 50 participants were randomized to TAB or control conditions. Participants in the TAB group completed bimonthly visits to ingest medication and receive take-home doses via a computerized device. They received nightly calls via an interactive voice response (IVR) system, IVR-generated random call-backs, and iPad-delivered HIV, hepatitis C virus (HCV), and overdose education. Control participants received community resource guides and assistance with contacting resources. All participants received harm reduction supplies and completed monthly assessments. Main Outcomes and Measures: The primary outcome was biochemically verified illicit opioid abstinence across monthly assessments. Secondary outcomes included self-reported opioid use in both groups and abstinence at bimonthly and random call-back visits, treatment adherence, satisfaction, and changes in HIV, HCV, and overdose knowledge among TAB participants. Results: Fifty individuals (mean [SD] age, 40.6 [13.1] years; 28 [56.0%] male) participated in trial 1, and 50 (mean [SD] age, 40.3 [10.8] years; 30 [60.0%] male) participated in trial 2. Participants in the TAB group achieved significantly greater illicit opioid abstinence vs controls at all time points in both trial 1 (85.3% [128 of 150]; 95% CI, 70.7%-93.3%; vs 24.0% [36 of 150]; 95% CI, 13.6%-38.8%) and trial 2 (88.0% [132 of 150]; 95% CI, 72.1%-95.4%; vs 21.3% [32 of 150]; 95% CI, 11.4%-36.5%). High abstinence rates were also observed at TAB participants' bimonthly dosing visits (83.0% [95% CI, 67.0%-92.0%] for trial 1 and 88.0% [95% CI, 71.0%-95.0%] for trial 2). Treatment adherence was favorable and similar between trials (with rates of approximately 99% for buprenorphine administration, 93% for daily IVR calls, and 92% for random call-backs), and 183 of 187 urine samples (97.9%) tested negative for illicit opioids at random call-backs. iPad-delivered education was associated with significant and sustained increases in HIV, HCV, and overdose knowledge. Conclusions and Relevance: In these randomized clinical trials of TAB treatment, demonstration of efficacy was extended to a longer duration than previously examined and to patients residing in rural communities. Trial Registration: ClinicalTrials.gov Identifier: NCT03420313.

Extending contingency management for smoking cessation to patients with or at risk for cardiovascular disease: A preliminary trial of a home-based intervention.

Cigarette smoking puts individuals with or at risk for developing cardiovascular disease (CVD) in jeopardy of experiencing a major cardiovascular event. Contingency management (CM) for smoking cessation is an intervention wherein financial incentives are provided contingent on biochemically verified smoking abstinence. Conventional CM programs typically require frequent clinic visits for abstinence monitoring, a potential obstacle for patients with medical comorbidities who may face barriers to access. This preliminary study examined the feasibility and comparative efficacy of (a) usual care (UC; advice to quit smoking, self-help materials, quitline referral) versus (b) UC plus home-based CM for smoking cessation (UC + HBCM). HBCM entailed earning monetary-based vouchers contingent on self-reported 24-hr smoking abstinence biochemically verified by a breath carbon monoxide (CO) sample ≤ 6 ppm. Participants were 20 outpatients with a CVD diagnosis or qualifying CVD risk factor randomly assigned 1:1 to the two conditions. Intervention participants received 14 in-home abstinence visits over 6 weeks. Voucher monetary value started at $10 and escalated by $2.50 for each subsequent negative sample (maximum earnings: $367.50). Positive samples earned no vouchers and reset voucher value to $10, but two negative samples following a positive allowed participants to continue earning vouchers at the prereset value. Primary outcome was point-prevalence smoking abstinence at Week 6 assessment. More participants assigned to UC + HBCM than UC were smoking abstinent at that Week 6 assessment (90% vs. 30%), χ²(1, N = 20) = 7.5, p < .01. These results provide initial evidence that HBCM can effectively promote smoking abstinence in CVD outpatients. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Randomized clinical trial examining financial incentives for smoking cessation among mothers of young children and possible impacts on child secondhand smoke exposure.

This randomized clinical trial examined whether financial-incentives increase smoking cessation among mothers of young children and potential impacts on child secondhand-smoke exposure (SHSe). 198 women-child dyads were enrolled and assigned to one of three treatment conditions: best practices (BP, N = 68), best practices plus financial incentives (BP + FI, N = 63), or best practices, financial incentives, and nicotine replacement therapy (BP + FI + NRT, N = 67). The trial was completed in Vermont, USA between June 2015 and October 2020. BP entailed staff referral to the state tobacco quitline; financial incentives entailed mothers earning vouchers exchangeable for retail items for 12 weeks contingent on biochemically-verified smoking abstinence; NRT involved mothers receiving 10 weeks of free transdermal nicotine and nicotine lozenges/gum. Baseline, 6-, 12-, 24-, and 48-week assessments were conducted. Primary outcomes were maternal 7-day point-prevalence abstinence and child SHSe through the 24-week assessment with the 48-week assessment exploratory. Results were analyzed using mixed model repeated measures for categorical data. Odds of maternal abstinence were greater among mothers in BP + FI and BP + FI + NRT compared to BP at the 6- and 12-week assessments (ORs ≥ 7.30; 95% CIs: 2.35-22.71); only abstinence in BP + FI remained greater than BP at the 24-week assessment (OR = 2.95; 95% CIs: 1.06-8.25). Abstinence did not differ significantly between treatment conditions at the 48-week assesssment. There was a significant effect of treatment condition (F[2109] = 3.64, P = .029) on SHSe with levels in BP and BP + FI significantly below BP + FI + NRT (ts[109] ≥ -2.30, Ps ≤ 0.023). Financial incentives for smoking abstinence are efficacious for increasing maternal cessation but that alone was insufficient for reducing child SHSe. ClinicalTrials.gov:NCT05740098.