Nicotine gum for pregnant smokers: a randomized controlled trial.
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ABSTRACT:
SUBMITTER: Oncken C
PROVIDER: S-EPMC2630492 | biostudies-literature | 2008 Oct
REPOSITORIES: biostudies-literature
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Nicotine gum for pregnant smokers: a randomized controlled trial.
Oncken Cheryl C Dornelas Ellen E Greene John J Sankey Heather H Glasmann Allen A Feinn Richard R Kranzler Henry R HR
Obstetrics and gynecology 20081001 4
<h4>Objective</h4>To estimate the safety and efficacy of treatment with 2-mg nicotine gum for smoking cessation during pregnancy.<h4>Methods</h4>Pregnant women who smoked daily received individualized behavioral counseling and random assignment to a 6-week treatment with 2-mg nicotine gum or placebo followed by a 6-week taper period. Women who did not quit smoking were instructed to reduce the number of cigarettes smoked by substituting with gum. Measures of tobacco exposure were obtained throug ...[more]
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Project description:IntroductionNon-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit.MethodsITS (smoking 4-27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects.ResultsNicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58-3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time.ConclusionsNicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence.ImplicationsNicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS' smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence.
| S-EPMC7297094 | biostudies-literature
Project description:Recruiting pregnant smokers into clinical trials is challenging since this population tends to be disadvantaged, the behavior is stigmatized, and the intervention window is limited. The purpose of this study is to test the feasibility and effectiveness of recruiting pregnant smokers into a smoking cessation trial by sending recruitment text messages to an existing subscriber list. Recruitment messages were sent to subscribers flagged as pregnant in Text4baby, a national text messaging program for pregnant women and mothers. Four recruitment messages were rotated to test the effectiveness of different emotional frames and a financial incentive. Study staff called subscribers who expressed interest to screen for eligibility and enroll eligible women. Between October 6, 2015 and February 2, 2016, 10,194 recruitment messages were sent to Text4baby subscribers flagged as pregnant, and 10.18% (1038) responded indicating interest. No significant increase in cancellation was observed compared to subscribers who received other ad hoc messages. Of respondents, 54.05% (561) were reached by phone for follow-up, and 21.97% (228) were found to be eligible. Among the eligible, 87% (199) pregnant smokers enrolled. The recruitment message with a pride emotional appeal had a significantly higher response (p = 0.02) compared to the recruitment message with no emotional appeal, but enrollment did not significantly differ between recruitment messages with different emotional appeals. The recruitment messages with a reference to financial incentive yielded higher response (p < 0.01) and enrollment (p = 0.03) compared to a recruitment message without. This study demonstrates success recruiting pregnant smokers using text message. Future studies should consider building on this approach for recruiting high-risk populations.
| S-EPMC5526806 | biostudies-other
Project description:ObjectiveTo determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day).DesignRandomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013.Setting23 maternity wards in France.Participants476 pregnant smokers aged more than 18 years and between 12 and 20 weeks' gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group.InterventionsNicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support.Main outcome measuresThe primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤ 8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis.ResultsComplete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group.ConclusionThe nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses.Trial registrationClinicalTrials.gov NCT00507975.
| S-EPMC3950302 | biostudies-literature
Project description:We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.
| S-EPMC3679235 | biostudies-literature
Project description:BackgroundBupropion is used to treat depression during pregnancy. However, its usefulness as a smoking cessation aid for pregnant women is not fully known.ObjectiveThe objective of the study was to evaluate the preliminary efficacy of bupropion sustained release for smoking cessation during pregnancy.Study designWe conducted a randomized, prospective, double-blind, placebo-controlled, pilot trial. Pregnant women who smoked daily received individualized behavior counseling and were randomly assigned to a 12 week, twice-a-day treatment with 150 mg bupropion sustained release or placebo. The primary study objectives were to determine whether bupropion sustained release reduces nicotine withdrawal symptoms on the quit date and during the treatment period compared with placebo and whether it increases 7 day point prevalence abstinence at the end of the treatment period and at the end of pregnancy.ResultsSubjects in the bupropion (n = 30) and placebo (n = 35) groups were comparable in age, smoking history, number of daily smoked cigarettes, and nicotine dependence. After controlling for maternal age and race, bupropion sustained release reduced cigarette cravings (1.5 ± 1.1 vs 2.1 ± 1.2, P = .02) and total nicotine withdrawal symptoms (3.8 ± 4.3 vs 5.4 ± 5.1, P = .028) during the treatment period. Administration of bupropion sustained release reduced tobacco exposure, as determined by levels of carbon monoxide in exhaled air (7.4 ± 6.4 vs 9.1 ± 5.8, P = .053) and concentrations of cotinine in urine (348 ± 384 ng/mL vs 831 ± 727 ng/mL, P = .007) and increased overall abstinence rates during treatment (19% vs 2%, P = .003). However, there was no significant difference in 7 day point prevalence abstinence rates between the 2 groups at the end of medication treatment (17% vs 3%, P = .087) and at the end of pregnancy (10% vs 3%, P = .328).ConclusionIndividual smoking cessation counseling along with the twice-daily use of 150 mg bupropion sustained release increased smoking cessation rates and reduced cravings and total nicotine withdrawal symptoms during the treatment period. However, there was no significant difference in abstinence rates between groups at the end of medication treatment and at the end of pregnancy, likely because of the small sample size. A larger study is needed to confirm these findings and to examine the potential benefit/ risk ratio of bupropion sustained release for smoking cessation during pregnancy.
| S-EPMC5376363 | biostudies-literature
Project description:Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.ClinicalTrials.gov: NCT01429129.
| S-EPMC3198706 | biostudies-literature
Project description:The primary aim was to compare the efficacy of smoking cessation treatment using a combination of active nicotine patch plus active nicotine gum versus therapy consisting of active nicotine patch plus placebo gum in a sample of alcohol-dependent tobacco smokers in an early phase of out-patient alcohol treatment. A secondary aim was to determine whether or not there were any carry-over effects of combination nicotine replacement on drinking outcomes.Small-scale randomized double-blind placebo-controlled clinical trial with 1-year smoking and drinking outcome assessment.Two out-patient substance abuse clinics provided a treatment platform of behavioral alcohol and smoking treatment delivered in 3 months of weekly sessions followed by three monthly booster sessions.Participants were 96 men and women with a diagnosis of alcohol abuse or dependence and smoking 15 or more cigarettes per day.All participants received open-label transdermal nicotine patches and were randomized to receive either 2 mg nicotine gum or placebo gum under double-blind conditions.Analysis of 1-year follow-up data revealed that patients receiving nicotine patch plus active gum had better smoking outcomes than those receiving patch plus placebo gum on measures of time to smoking relapse and prolonged abstinence at 12 months. Alcohol outcomes were not significantly different across medication conditions.Results of this study were consistent with results of larger trials of smokers without alcohol problems, showing that combination therapy (nicotine patch plus gum) is more effective than monotherapy (nicotine patch) for smoking cessation.
| S-EPMC2753831 | biostudies-literature
Project description:ObjectiveThe purpose of this study was to assess whether pregnant smokers have the same nicotine intake from cigarettes as a general population of smokers and whether the known lower daily cigarette consumption among pregnant smokers is associated with higher nicotine intake among pregnant smokers.MethodThe study was a cross-sectional comparison of pregnant smokers and a general population of smokers in smoking cessation clinics. Participants were treatment-seeking pregnant (n = 476), nonpregnant female (n = 116), and male (n = 195) smokers who participated in two independent smoking cessation trials. Nicotine intake was measured as saliva cotinine/ cigarette/kg body weight ratio.ResultsThe mean saliva cotinine (μg/L)/ cigarette/kg body weight (0.21, SD = 0.15) of pregnant smokers was similar to that of nonpregnant female smokers (0.24, SD = 0.14) and higher than that of male smokers (0.18, SD = 0.12, p = .002) despite a substantially lower number of cigarettes per day (pregnant smokers: 12, SD = 6; nonpregnant female smokers: 26.6, SD = 11.7; male smokers: 23.5, SD = 9.5, p < .001). Among pregnant smokers, saliva cotinine, as expected, increased in parallel with the number of cigarettes per day, but nicotine intake (cotinine/cigarette/kg body weight) was inversely associated with daily cigarette consumption (p < .001). No association between cigarettes per day and nicotine intake was observed in male and nonpregnant female smokers (p = .43).ConclusionsThis secondary analysis showed that pregnant smokers' nicotine intake was similar to that of a general population of smokers despite a lower cigarette consumption rate. Among pregnant smokers, lower daily cigarette consumption was associated with higher nicotine intake from cigarettes, suggesting compensatory smoking.
| S-EPMC9798487 | biostudies-literature
Project description:IntroductionThis secondary analysis examined the association between adherence to nicotine replacement therapy (NRT) and smoking cessation among pregnant smokers enrolled in Baby Steps, an open-label randomized controlled trial testing cognitive-behavioral therapy (CBT) versus CBT plus NRT.MethodThe analysis included only women who received NRT for whom we had complete data (N = 104). Data came from daily calendars created from recordings of counseling sessions and from telephone surveys at baseline and 38 weeks gestation.ResultsOverall, 29% of the 104 women used NRT for the recommended 6 weeks and 41% used NRT as directed in the first 48 hr after a quit attempt. Ordinal logistic regression modeling indicated that using NRT as directed in the first 48 hr and having made a previous quit attempt were the strongest predictors of longer NRT use. Univariate analyses suggested that primigravid women and women who used NRT longer were more likely to report quitting at 38 weeks gestation.DiscussionFindings indicated that adherence to NRT is low among pregnant smokers, but adherence was a predictor of cessation. Future trials should emphasize adherence, particularly more days on NRT, to promote cessation during pregnancy.
| S-EPMC2671460 | biostudies-literature
Project description:ObjectivesNicotine nasal spray has been 1 of the most successful forms of nicotine-replacement therapy in adult populations. The nasal sprayer has not been studied in adolescent smokers. The objective of this pilot study was to determine the feasibility and utility of using nicotine nasal spray for adolescent smokers who wanted to quit smoking.MethodsForty adolescent smokers who were between 15 and 18 years of age and smoked >/=5 cigarettes daily for at least 6 months were recruited from several San Francisco Bay area schools from 2005 to 2007. Using a randomized, open-label, 12-week trial, adolescent smokers were assigned to receive either weekly counseling alone (control) for 8 weeks or 8 weeks of counseling along with 6 weeks of nicotine nasal spray. Self-reported smoking abstinence was verified by both expired-air carbon monoxide and salivary cotinine.ResultsThere was no difference in cessation rates, the numbers of cigarettes smoked per day, or cotinine levels at 12 weeks. Fifty-seven percent of participants stopped using their spray after only 1 week. The most commonly reported adverse effect was nasal irritation and burning (34.8%) followed by complaints about the taste and smell (13%).ConclusionsThe unpleasant adverse effects, poor adherence, and consequent lack of efficacy observed in our pilot study do not support the use of nicotine nasal spray as an adjunct to counseling for adolescent smokers who wish to quit.
| S-EPMC2744418 | biostudies-literature