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.

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.

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).

Using the Cigarette Purchase Task to examine the relative reinforcing value of cigarettes among mothers with versus without opioid dependence.

The Cigarette Purchase Task (CPT), in which participants estimate the number of cigarettes they would smoke across increasing cigarette prices, measures the relative reinforcing value of cigarettes. Although opioid-dependent individuals are particularly vulnerable to tobacco addiction, more research is needed to elucidate whether and to what extent their motivation to smoke differs from not-opioid-dependent smokers controlling for potential sociodemographic differences. Participants were 173 women (65 opioid-dependent) in an ongoing clinical trial for smoking cessation. Baseline CPT responses were compared between opioid-dependent and not-opioid-dependent women using five demand indices: Demand Intensity; Omax; Pmax; Breakpoint (BP); and α, and two latent factors: Amplitude and Persistence. Final regression models adjusted for sociodemographic characteristics differing between the two groups. Opioid-dependent women had greater demand Intensity (i.e., number of cigarettes they would smoke if they were free) than not-opioid dependent women in the adjusted model, F(1, 156) = 6.93, p = .016. No other demand indices differed significantly. Regarding latent factors, demand Amplitude (i.e., volumetric consumption), but not Persistence (i.e., price insensitivity), was greater for opioid-dependent women in the adjusted model, F(1, 146) = 4.04, p = .046. These results further demonstrate that the CPT is a highly sensitive task that can illuminate potentially important individual and population differences in the relative reinforcing value of smoking. Greater demand Intensity and Amplitude differentiated smokers with comorbid opioid dependence; thus, decreasing smoking prevalence among opioid-dependent populations may require policies and interventions that can decrease cigarette demand Intensity and Amplitude. (PsycInfo Database Record (c) 2020 APA, all rights reserved).