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. Author manuscript; available in PMC: 2024 Nov 1.
Published in final edited form as: Prev Med. 2023 Jul 30;176:107651. doi: 10.1016/j.ypmed.2023.107651

Randomized Clinical Trial Examining Financial Incentives for Smoking Cessation Among Mothers of Young Children and Possible Impacts on Child Secondhand Smoke Exposure

Stephen T Higgins a,b,c, Shirley Plucinski a,b, Eva Orr a,b, Tyler D Nighbor a,b, Sulamunn RM Coleman a,b, Joan Skelly a,d, Michael DeSarno a,d, Janice Bunn a,d
PMCID: PMC10825067  NIHMSID: NIHMS1923599  PMID: 37527730

Abstract

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[2,109]=3.64, P=.029) on SHSe with levels in BP and BP+FI significantly below BP+FI+NRT (ts[109]≥−2.30, Ps≤.023). Financial incentives for smoking abstinence are efficacious for increasing maternal cessation but that alone was insufficient for reducing child SHSe.

ClinicalTrials.gov: NCT05740098

Keywords: smoking cessation, women, mothers, secondhand smoke exposure, best practices, financial incentives, nicotine replacement therapy

Smoking among women is sufficiently important to U.S. public health to warrant two separate U.S. Surgeon General reports devoted exclusively to this topic (USDHHS, 1980; 2001) and considerable space in two others examining effects on reproductive health (e.g., USDHHS 2014, 2020). Smoking prevalence among women is unevenly distributed in the U.S., being highly concentrated among individuals with lower socioeconomic status and more recently those residing in rural regions (Cepeda-Benito et al., 2018; Higgins & Chilcoat, 2009; Kurti et al., 2017; Lopez et al., 2018; Nighbor et al., 2018). These differences in smoking contribute directly to worsening U.S. health disparities (e.g., Crear-Perry et al., 2021; Schroeder, 2016; Woolf & Schoomaker, 2019). Not surprisingly, there is broad consensus on the need for more effective interventions to reduce smoking among women of reproductive age, especially those who are pregnant or mothering young children due to the potential for multigenerational adverse health impacts (e.g., Chamberlain et al., 2017; Claire et al., 2020; Higgins et al., 2009).

Financial incentives have been demonstrated in randomized clinical trials (RCTs) to be an efficacious, scalable, and cost-effective intervention for increasing smoking cessation among perinatal women (e.g., Berlin et al., 2021; Boyd et al., 2016; Chamberlain et al., 2017; Heil et al., 2008; Higgins et al., 2012, 2014, 2022; Lumley et al., 2009; Shepard et al., 2022; Tappin et al., 2015, 2022). The purpose of the RCT reported here is to extend this financial-incentives model to smoking cessation among mothers of young children (< 12 yrs old). In addition to benefitting the health of mothers, successful cessation in this population has potential to reduce child secondhand smoke exposure (SHSe). Despite widespread knowledge of the harmful effects of SHSe, children from socioeconomically disadvantaged families often experience chronic exposure (Karaca-Mandic et al., 2021; Tsai et al., 2018). Childhood SHSe increases risk for serious adverse health impacts (USDHHS, 2006, 2010, 2014) and is also a substantial economic burden (CDC 2023; USDHHS 2014; Max et al., 2012).

To our knowledge, the present RCT is the first to examine whether financial incentives increase smoking cessation among mothers of young children and potential impacts on SHSe. We also examined whether adding combined short (lozenges/gum) and longer acting (transdermal) nicotine replacement therapy (NRT) to financial incentives enhances cessation outcomes (Ebbert et al., 2010; Wadgave & Nagesh, 2016). We know of only four controlled studies examining the effects of combined financial incentives and pharmacotherapy on smoking cessation and none with mothers of young children. In two placebo-controlled studies among adults with schizophrenia, financial incentives increased abstinence from smoking across 5-day and 21-day study periods, with no evidence of greater abstinence when combining the incentives with active 21 mg transdermal NRT (Tidey et al., 2002) or 300 mg/day bupropion SR (Tidey et al., 2011) compared to placebo. Two other studies used two-by-two factorial designs to compare incentives vs. no-incentives and transdermal NRT vs. placebo (Perkins et al., 2008) or 1 mg b.i.d. varenicline vs. placebo (Perkins et al., 2010) across 5-day periods in adults from the general population. Incentives and active medication each increased abstinence levels alone and in an additive manner when combined.

Methods

Trial Participants

Our goal was to enroll 250 women (10 for pilot testing and 240 assigned across three treatment conditions). Participants were recruited from local Pediatric Offices, Women, Infants, and Children (WIC) clinics, ads on Craig’s list and Facebook, and referrals from study participants. For inclusion, women had to express interest in quitting smoking, be ≥18 years of age, willing to initiate NRT, biochemically verified as currently smoking, report smoking ≥ 10 cigarettes per day (CPD) for ≥ past year, not currently using smoking-cessation medications, reside in the county in which the study clinic is located or a surrounding county, plan to remain in the area for the next 12 months, English speaking, have a child <12 years residing with her full time, and allow her youngest child to participate in the study. Exclusion criteria included medical contraindications to NRT, moderate/severe substance use disorder other than nicotine in the prior 12 months (those receiving medication for opioid use disorder [OUD] were eligible), current or past psychotic disorder, currently suicidal, and currently pregnant or planning to become pregnant in next 12 months.

A Consort diagram detailing participant enrollment is shown in Figure 1. 991 women began prescreening, 407 of whom failed to complete prescreening and 183 others were deemed ineligible. The remaining 401 were invited to full screening, with 25 declining, 128 failing to attend screening, 21 failing to complete screening, and 19 deemed ineligible. A total of 208 women were eligible and consented. Ten eligible women were enrolled for pilot testing; 198 were enrolled in the trial and randomly assigned to one of the three treatment conditions stratifying on four criteria: (1) maternal smoking level (< vs. ≥20 CPD), (2) maternal educational attainment (< vs. ≥12 yrs), (3) number of other smokers living in the household (1 vs. ≥2), (4) child age (<6 yrs of age vs. 6–11). Final enrollment was 198 of the 250 (79%) mother-child dyads proposed. Primary reason for failing to meet recruitment goal was fewer referrals than anticipated from collaborating Pediatric offices. The 198 mothers were randomly assigned to the following three smoking-cessation conditions: Best Practices alone (N=68), Best Practices plus Financial Incentives (N=63), Best Practices, Financial Incentives, and Nicotine Replacement Therapy (N=67).

Figure 1.

Figure 1.

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Consort diagram of trial enrollment.

Trial Assessments

The intake assessment collected information in seven areas: (1) Socio-demographics; (2) Smoking history including Fagerstrom Test for Nicotine Dependence total scores (FTND, Heatherton et al. 1991), Nicotine Withdrawal Scale total scores (Hughes & Hatsukami, 1986), and Timeline Follow-back (Brown et al., 1998); (3) Smoking attitudes on quitting; (4) maternal breath carbon monoxide (CO) (piCO Breath CO Monitor, Bedfont Scientific Ltd) and maternal and child urine cotinine (liquid chromatography-tandem mass spectrometry, LC-MS/MS); for children in diapers urine specimens were collected via cotton pads in the diaper (e.g., Hovell et al., 2009); (5) SHSe questionnaires regarding maternal smoking in the house and that of others inside and outside the home with exposure quantified as number of cigarettes smoked with child in the room or car (Hovell et al., 2009); (6) maternal medical/mental health including current medical concerns/problems, medications currently used, allergies, medical history, systems review, substance use history, lifetime history of depression, current depressive symptoms (Beck Depression Inventory, Beck et al., 1996), stress level during past week on a 1 (no stress) to 10 (extreme stress) ordinal scale; (7) Behavioral-economic measures: Monetary Choice Questionnaire to assess delay discounting (MCQ-27; Kirby et al., 1999) with hyperbolic discounting parameter (k value) determined using the spreadsheet in Kaplan et al. (2016); and the hypothetical Cigarette Purchase Task (CPT, Jacobs & Bickel, 1999) using a version adapted from MacKillop et al. (2008) as detailed in Nighbor et al. (2019); CPT outcomes examined were latent factors Amplitude (demand unconstrained by price) and Persistence (demand sensitivity to price) as detailed in Higgins et al. (2020).

Modified versions of this battery were completed at 6-, 12-, 24- and 48-week follow-up assessments. Urine specimens collected at these assessments were analyzed by an outside laboratory using LC-MS/MS and those are the results reported here. Abstinence cutpoint for maternal cotinine was < 50 ng/ml using anatabine levels to discern between cotinine from NRT (<2.0 ng/ml) versus smoking (≥2.0 ng/ml) (Jacob et al., 2002).

Trial Conditions

Best Practices (BP).

Study staff implemented the 5 As (Fiore et al., 2008) and made a fax referral to the Vermont Quit Network (http://802quits.org). This network offers free cessation services including NRT mailed directly to the participant’s home (~2-week delay), web-based modules on quitting, and individual phone counseling. Study staff was not involved with services offered through the Quitline nor did they confirm referred women’s use of the service.

Best Practices + Financial Incentives (BP+FI).

Participants received the BP services described above plus 12 weeks of financial incentives (vouchers exchangeable for retail items) for biochemically verified abstinence (breath CO <6 ppm) (maximum earnings=$810.00). The initial smoking-negative test was worth $10.00. Each consecutive negative test increased incentive value by $2.50, with the 2nd negative test worth $12.50, the 3rd test $15.00, etc. Incentive value continued to escalate based on consecutive negative test results to a maximum value of $50.00. Positive tests or unexcused absences reset incentives back to initial $10.00 value. Two consecutive negative tests following a reset returned incentive value to pre-reset levels. Mean (±SEM) voucher earnings were $432.78±43.24.

Best Practices + Financial Incentives + Nicotine Replacement Therapy (BP+FI+NRT).

Participants received all services described above for the BP+FI condition plus the following pharmacotherapy protocol: (1) A clear staff recommendation to use NRT. Staff immediately registered women who agreed to initiate NRT with the Vermont Quitline asking for free NRT using the study clinic address as delivery site. Staff also had NRT available onsite so pharmacotherapy could be implemented immediately after a woman agreed. Supply was replenished as needed when the requested Quitline package arrived. The protocol used over-the-counter NicoDerm CQ, GlaxoSmithKline Consumer Healthcare. (2) Following their quit date, participants were recommended to follow a standard 10-week course of transdermal NRT using the 21mg/24-hr patch for 6 weeks, the 14mg/24-hr patch for 2 weeks, and the 7 mg/24-hr patch for 2 weeks. Additionally, participants were encouraged to use nicotine lozenges (or gum) in combination with transdermal NRT beginning on quit date. We used Commit (GlaxoSmithKline Consumer Healthcare) brand of 2 or 4 mg lozenges in various flavors, with those who smoke within 30 mins of waking recommended to use the higher dose and those who initiated smoking later to use the lower dose. We encouraged use of lozenges for 10 weeks. Women received a one-week supply of NRT at their 1st weekly clinic visit. Staff assessed medication side-effects and recommended dose or other adjustments to the regimen as warranted. Mean (±SEM) voucher earnings in this condition were $347.98±45.54.

Abstinence Monitoring Schedule

Participants were asked to choose a Monday in next two weeks as their quit date. Beginning on quit date, participants were asked to report to the study clinic or be met at a convenient location according to a predetermined 12-week schedule. Week 1 involved five consecutive days (M-F) of once-daily breath-CO monitoring. The breath-CO cutpoint of <6 ppm was used to determine eligibility for vouchers in the BP+FI and BP+FI+NRT conditions. In Weeks 2–8, abstinence monitoring was reduced to twice weekly (M & Th or Tu & F). To encourage schedule adherence among those assigned to the BP condition, they received $15.00 in vouchers per visit independent of smoking status. Earnings in the BP+FI and BP+FI+NRT conditions were contingent on abstinence as detailed above.

Statistical Methods

Treatment conditions were compared on baseline characteristics using analysis of variance for continuous measures and chi-square tests for categorical variables. Primary analyses included all participants randomly assigned to treatment conditions consistent with an intent-to-treat approach (Armitage, 1983). The 1st of two primary outcome measures in this trial was point-prevalence smoking abstinence at 6- through 24-week assessments. Abstinence at 48 weeks was an exploratory outcome. We assessed continuous abstinence across the 6-, 12- (end-of-treatment), 24- (follow-up), and 48-week (exploratory follow-up) assessments. Abstinence was defined as self-report of no smoking in past 7 days and urine-cotinine confirmation by an outside laboratory. Comparisons of point-prevalence abstinence among treatment conditions across all periodic assessments were analyzed using mixed model repeated measures for categorical data based on generalized estimating equations utilizing a logistic link function (PROC GENMOD) with assessment time, treatment condition, and their interaction as factors. Treatments were compared on percent of women continuously abstinent across consecutive assessments using chi-square tests. A significant overall chi-square test was followed up with pairwise tests. We also repeated the analysis assessing whether there were significant differences in the effect of treatment condition on point-prevalence abstinence by whether mothers were currently enrolled in treatment for OUD. The 2nd of the two primary outcomes was child SHSe defined by urine cotinine levels analyzed by an outside laboratory. Treatment comparisons and temporal changes in children’s mean urine cotinine were examined with mixed-model, repeated-measures analysis (PROC MIXED) adjusting for potential confounders (Collins et al., 2020). This procedure uses maximum likelihood estimation which allows the use of all available data for cases with incomplete urine cotinine data. Analysis of covariance at each assessment was used to compare urine cotinine levels between children of mothers abstinent from smoking versus those continuing to smoke. The models included the same covariates as the mixed model described above. Because cotinine levels are typically skewed, data were log transformed prior to analyses. Logistic regression at each assessment was used to examine whether baseline Cigarette Purchase Task latent-factor scores Amplitude and Persistence or delay discounting, expressed as the logarithm of each participant’s estimated parameter k, predicted smoking abstinence. These models included the baseline value, treatment condition, and the interaction. If the interaction was not significant it was removed from the model. Statistical analyses were performed using SAS statistical software Version 9.4 (SAS Institute, Cary NC). Statistical significance was determined based on α =.05.

Results

Participants

Participant characteristics did not differ significantly between treatment conditions (Table 1). On average, mothers were 32.56±6.17 years old and participated with their youngest child who was 3.80±3.23 years old. Most were unmarried, not currently working outside the home, insured through Medicaid or equivalent programs, and predominately non-Latino white consistent with prior trials with perinatal women in Vermont (Higgins et al., 2022). Mothers reported smoking 16.68±6.30 cigarettes per day, moderate dependence severity, most reported prior quit attempts, approximately half lived with someone who smokes, and the vast majority (81%) allowed smoking in the home.

Table 1:

Participant Characteristics

Characteristics Overall (n=198) BP1 (n=68) BP + FIs2 (n=63) BP + FIs + NRT3 (n=67) p-value
Demographics:
Mother’s age (years) 32.56 ± 6.17 32.95 ± 5.86 31.82 ± 6.18 32.88 ± 6.50 0.52
Child’s age (years) 3.80 ± 3.23 3.73 ± 3.32 3.67 ± 3.29 4.00 ± 3.10 0.82
Income 30046 ± 27642 31637± 28539 27753 ± 23419 30744 ± 30851 0.72
Married n(%) 40(21) 11(17) 16(26) 13(20) 0.44
Education 0.29
 Less than HS n(%) 48(25) 14(21) 13(21) 21(33)
 HS n(%) 54(28) 17(26) 22(35) 15(23)
 Greater than HS n(%) 90(47) 35(53) 27(44) 28(44)
Non-Hispanic White n(%) 177(92) 60(91) 57(92) 60(94) 0.83
Currently working for pay outside of home n(%) 82(43) 28(43) 29(47) 25(39) 0.68
Have private health insurance n(%) 37(19) 14(21) 9(14) 14(21) 0.54
Smoking Characteristics:
Age first started smoking cigarettes regularly 15.38 ± 3.14 15.41 ± 2.84 15.24 ± 2.97 15.47 ± 3.61 0.92
Average number of cigarettes per day on days when smoke 16.79 ± 6.28 16.89 ± 6.78 16.32 ± 6.12 17.16 ± 5.98 0.75
4Fagerström 4.68 ± 2.20 4.82 ± 2.04 4.32 ± 2.32 4.89 ± 2.23 0.29
Opioid dependent n(%) 79(40) 27(40) 26(41) 26(39) 0.96
Ever tried to quit smoking completely n(%) 173(90) 59(89) 58(94) 56(88) 0.51
Live with a smoker n(%) 93(49) 32(50) 32(53) 29(45) 0.67
Friends Smoke n(%) 75(39) 26(39) 28(45) 21(33) 0.36
Smoking allowed in home n(%) 155(81) 55(83) 50(81) 50(78) 0.75
Secondhand smoke exposure advice 1.78 ± 1.16 1.97 ± 1.10 1.81 ± 1.17 1.58 ± 1.18 0.16
Support from family and friends if decided to quit 3.48 ± 0.84 3.44 ± 0.91 3.52 ± 0.72 3.59 ± 0.77 0.74
Psychiatric Condition/Symptoms:
BDI 9.12 ± 7.39 9.79 ± 6.92 8.32 ± 7.01 9.20 ± 8.23 0.53
How stressed in past week 5.80 ± 2.40 5.80 ± 2.60 6.06 ± 2.16 5.31 ± 2.42 0.46
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Note: Reported values are Means ± SD unless otherwise specified;

p-values are from analysis of variance for continuous variables and chi-square tests for categorical variables.

1

Best Practices (BP)

2

Best Practices + Financial Incentives (BP + FI)

3

Best Practices + Financial Incentives + Combination short- and long-acting Nicotine Replacement Therapy (BP + FI + NRT)

4

Fagerström Test for Nicotine Dependence

Maternal Abstinence

The first of the two primary aims was increasing point-prevalence abstinence through the 24-week assessment. The effects of treatment condition on cessation rates interacted with assessment time (χ2(4)=11.21, P=.024), with BP+FI increasing odds of cessation above BP levels at the 6-, 12-, and 24-week assessments (ORs≥2.95;95%CIs: 1.06–8.25) while BP+FI+NRT increased odds of cessation above BP levels at 6- and 12-weeks (ORs≥5.88;95%CIs: 1.87–18.48) but not 24-weeks (OR=2.25;95%CIs: 0.79–6.41) (Figure 2, upper panel). The two incentive conditions did not differ from each other at any assessment. We saw no evidence that response to the three cessation interventions interacted with maternal OUD (χ2(4)=4.96, P=.291). Smoking cessation levels at the exploratory 48-week assessment were 17.46%, 8.96%, and 7.35%, in BP+FI, BP+FI+NRT, and BP conditions, respectively, but those differences were not statistically significant (χ2(2)=3.86, P=.145).

Figure 2.

Figure 2.

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Shown are the percent of mothers biochemically confirmed to have achieved seven-day point-prevalence smoking abstinence during the intervention (6-week, 12-week) and follow-up (24-week, 24-week) periods (upper panel) and the percent biochemically confirmed to have sustained smoking abstinence across consecutive assessments (lower panel) among those randomly assigned to best practices alone (BP, best practices plus financial incentives (BP + FI), or best practices plus financial incentives plus combined short- and long-acting nicotine replacement therapy (BP + FI + NRT) across the 6-, 12-, (end-of-treatment), 24- (follow-up), and 48-week (exploratory follow-up) assessments. Note: data points not sharing a superscript letter differ significantly at P<.05.

A secondary aim was to examine continuous abstinence across assessments. The overall chi-square tests were significant when comparing treatment conditions on continuous abstinence across the 6- and 12-week (χ2(2) =16.84, P<.001) and 6-, 12-, and 24-week assessments (χ2(2)=6.84, P=.033) (Figure 2, lower panel). In pairwise chi-square tests there was significantly greater continuous abstinence in the BP+FI and BP+FI+NRT conditions compared to BP alone across the 6- 12- and 24-week assessments. There were no significant differences in continuous abstinence between BP+FI and BP+FI+NRT conditions nor between the three treatment conditions on the percent of participants who sustained continuous abstinence through the exploratory 48-week assessment, although abstinence levels trended towards favoring incentives at 1.47%, 11.11%, and 7.46%, in the BP, BP+FI, and BP+FI+NRT conditions, respectively (χ2(2)=5.09, P=.079).

Child Urine Cotinine Levels

The second primary aim was to assess treatment differences in child urine cotinine levels during 6- through 24-week assessments. There was a significant main effect of treatment condition (F[2,109]=3.64, P=.029) but no significant effects of assessment time (F[2,129]=0.37, P=.693) nor interactions of treatment condition and assessment time (F[4,125]=0.35, P=.35) (Figure 3). In post-hoc testing, geometric mean cotinine levels in children of mothers in BP+FI+NRT exceeded levels in the BP (t[109]=−2.30, P=.023) and BP+FI (t[109]=−2.37, P=.020) conditions. There was no significant effect of treatment at the 48-week assessment ((F[2,54]=2.17, P=.124), with geometric mean levels of 10.52±5.70, 2.44±1.11, and 5.46±2.76 in BP, BP+FI, and BP+FI+NRT conditions, respectively.

Figure 3.

Figure 3.

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Shown are mean geometric urine cotinine levels during weeks 6–24 among children of mothers randomly assigned to best practices alone (BP, best practices plus financial incentives (BP + FI), or best practices plus financial incentives plus combined short- and long-acting nicotine replacement therapy (BP + FI + NRT). Note: data points not sharing a superscript letter differ significantly at P<.05.

A comparison of geometric mean cotinine levels in children of mothers confirmed abstinent versus continuing to smoke at the 6- through 48-week assessments revealed no significant differences by maternal smoking status at any assessment (F[1,71]=1.19, P=0.280), F[1,83]=0.72, P=.399), F[1,71]=0.75, P=.389), F[1,55]<0.01, P=.978 across the 6-, 12-, 24- and 48-week assessments, respectively) (Table 2).

Table 2:

Child mean cotinine levels by maternal smoking status1

Assessments
Smoking Status 6 wks 12 wks 24 wks 48 wks
Abstinent 2.40 ±0.95 4.02 ±2.04 6.91 ±3.01 4.83 ±3.61
Smoking 4.12 ±1.07 6.77 ±2.00 4.41 ±1.06 4.72 ±1.46
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1

Data points are geometric means ± SEM urine cotinine levels (ng/ml). There were no significant differences between data points in the Abstinent and Smoking conditions at any assessment.

Behavioral-economic Measures

Baseline delay discounting was not significantly associated with overall abstinence levels at any assessment (χ2s(1)≤3.20, Ps≥.074) nor did it interact significantly with treatment in predicting abstinence (χ2s(2)≤3.03, Ps≥.220) (not shown).

Regarding baseline CPT latent factors, baseline Amplitude was not significantly associated with overall abstinence achieved at any assessment (χ2s(1)≤1.06, Ps≥.302), nor did it interact significantly with treatment condition in predicting abstinence at any assessment (χ2s(2)≤3.26, Ps>.196). Baseline Persistence was not significantly associated with overall abstinence achieved at any assessment (χ2s(1)≤0.65, Ps≥.422) nor did it interact significantly with treatment condition in predicting abstinence at the 12-, 24-, or 48-week assessments (χ2s(2)≤5.40, Ps>.067). There was a significant interaction with treatment condition and abstinence at 6-week assessment (χ2(2)=7.99, P=.018) where greater Persistence was associated with increased odds of abstinence in the BP+FI+NRT condition (OR=2.16; 95% CIs: 1.12–4.16), but not the BP+FI (OR=0.645; 95% CIs: 0.330–1.260) or BP (OR=1.154; 95% CIs: 0.007–3.565) conditions (not shown).

Discussion

The first of the two primary aims of this trial was well supported. Adding financial-incentives to best practices for smoking cessation increased 7-day point prevalence smoking abstinence during the 12-week intervention in this sample of mothers of young children and that effect remained significant through the 24-week follow-up assessment completed 12 weeks after discontinuation of financial incentives. Similarly, financial incentives increased the duration of continuous smoking abstinence across consecutive assessments through the 24-week assessment. Significant effects of treatment were not observed at the 48-week exploratory assessment, although the 7.56- and 5.07-fold greater continuous abstinence observed in the BP+FI and BP+FI+NRT compared to BP conditions at that assessment (11.11%, 7.46% and 1.47%, respectively) are suggestive of a sustained effect of incentives. To our knowledge, the present results extend for the first time the well-supported positive outcomes of financial incentives on smoking cessation observed with perinatal women to mothers of young children. This is a noteable incremental advance in development of efficacious smoking-cessation interventions for women of reproductive age many of whom are socioeconomically disadvantaged and at increased risk for smoking, heavy smoking, and difficulties quitting compared to the general population (Higgins & Chilcoat, 2009; Kurti et al., 2017; Lopez et al., 2018; Nighbor et al., 2018). It is also notable that these positive cessation outcomes were achieved in a sample in which 40% of participants were receiving medication treatment for OUD, also a population in whom smoking is highly prevalent, adverse smoking-related health impacts including premature death well documented (Hser et al 1994), and more effective cessation interventions sorely needed (Parker et al., 2020). These results are consistent with those from prior controlled trials (Dunn et al., 2010; Sigmon et al., 2016) and meta-analyses (Bolivar et al., 2021) supporting the efficacy of financial incentives for increasing smoking abstinence in patients receiving medication treatment for OUD and smoking cessation more generally (Notley et al., 2019).

Adding combined short- and long-acting NRT to financial incentives did not enhance cessation outcomes above levels observed with financial incentives alone, which is consistent with prior 5-day and 21-day proof-of-concept studies conducted with adults with schizophrenia (Tidey et al., 2002, 2011), but not those with adults from the general population of people who smoke where combining NRT and varenicline with incentives increased cessation rates above levels observed with financial incentives or medication alone (Perkins et al. 2008, 2010). We are unable to account for this between-study variability although at least two possible explanations seem plausible. First, discerning additive cessation effects may be more difficult in populations highly vulnerable to smoking due to their general lower likelihood of quitting compared to the general population who smoke. Second, we cannot rule out the possibility that participants in the BP and BP+FI conditions obtained the medications free through the tobacco quit line or purchased them from local pharmacies obscuring any differences between treatment conditions related to NRT use. Perhaps most importantly, we caution against reaching strong conclusions regarding the potential of promoting greater outcomes by combining financial incentives with pharmacotherapy compared to incentives alone until more data are available.

The second primary aim of this trial was to assess the impact of increasing maternal smoking cessation on SHSe levels of their young children. These results are quite clear that increasing maternal cessation was insufficient for reducing SHSe. The greater maternal cessation levels in BP+FI and BP+FI+NRT compared to BP did not translate into corresponding greater reductions in child cotinine levels. That outcome is not attributable to the magnitude of the increases in maternal cessation being insufficient as the additional analysis comparing cotinine levels in children of mothers who were confirmed abstinent to those still smoking similarly showed no significant differences in child SHSe levels. Indeed, the only significant difference in child cotinine levels was between BP and BP+FI versus BP+FI+NRT. Why child SHSe levels were poorest among mothers treated with BP+FI+NRT cannot be accounted for based on data collected in this trial, although transmission through breastmilk among mothers still nursing in BP+FI+NRT seems likely (Sachs, 2013). Perhaps this failure to significantly reduce child SHSe by increasing maternal smoking abstinence is not surprising considering that approximately half the mothers resided with others who smoked, most did not have bans on smoking in the home, and the intervention did not include explicit counseling of mothers on strategies for reducing SHSe in children. In terms of next steps, we believe that future trials investigating financial incentives for maternal abstinence in combination with evidence-based strategies for decreasing SHSe through home-based counseling of mothers on strategies to decrease smoke exposure warrant consideration (Collins et al., 2015; Collins et al. 2020).

This RCT is not without limitations. The study sample was almost exclusively non-Hispanic White (92%). While there is considerable evidence supporting the efficacy of financial incentives for increasing abstinence from substance use across a wide range of populations and psychoactive substances (e.g., Bolivar et al., 2021; Lussier et al., 2006) the homogeneity of this study sample should nevertheless be kept in mind when extending these observations to women of other race/ethnicities. Another is our ability to enroll only 78% (198/250) of the initially proposed sample size, which may have adversely impacted the precision of the differences observed between treatment conditions or compromised the ability to discern others. These limitations notwithstanding, we believe that the present results demonstrating that financial incentives increase smoking cessation rates across a 24-week study period among mothers of young children many of whom were socioeconomically disadvantaged and also undergoing treatment for OUD represents a substantive step in the direction of improving health and reducing the growing problem of health disparities (Higgins, 2014; Higgins & Chilcoat, 2009; Schroeder, 2016; Woolf & Schoomaker, 2019).

Highlights.

Financial incentives increase smoking cessation in mothers of young children.

Adding combined short and long acting NRT did not increase the efficacy of incentives.

This extends to mothers of young children an intervention effective in perinatal women.

Increasing mothers smoking cessation did not decrease child secondhand smoke exposure.

Funding sources

National Institute of Child Health and Human Development Research Award R01HD078332; National Institute of General Medical Sciences Center of Biomedical Research Excellence Award P20GM103644; National Institute on Drug Abuse Institutional Training Award T32DA007242. Funders had no role in the study.

Footnotes

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Declaration of interests

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

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