Dataset Information

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

ABSTRACT:

Background

This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation.

Methods

An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 weeks post-randomization, 38 weeks gestation, and 3 months postpartum.

Results

Women in the CBT+NRT arm were almost three times more likely than women in the CBT-only arm to have biochemically validated cessation at both pregnancy time points (after 7 weeks: 24% vs 8%, p=0.02; at 38 weeks gestation: 18% vs 7%, p=0.04), but not at 3 months postpartum (20% vs 14%, p=0.55). Recruitment was suspended early by an Independent Data and Safety Monitoring Board when an interim analysis found a higher rate of negative birth outcomes in the CBT+NRT arm than in the CBT-only arm. In the final analysis, the difference between the arms in rate of negative birth outcomes was 0.09 (p=0.26), when adjusted for previous history of preterm birth.

Conclusions

The addition of NRT to CBT promoted smoking cessation in pregnant women. This effect did not persist postpartum. More data are needed to determine safety parameters and to confirm the efficacy of NRT use during pregnancy.

SUBMITTER: Pollak KI

PROVIDER: S-EPMC3602964 | biostudies-literature | 2007 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

Pollak Kathryn I KI Oncken Cheryl A CA Lipkus Isaac M IM Lyna Pauline P Swamy Geeta K GK Pletsch Pamela K PK Peterson Bercedis L BL Heine R Phillips RP Brouwer Rebecca J Namenek RJ Fish Laura L Myers Evan R ER

American journal of preventive medicine 20071001 4

<h4>Background</h4>This study examines whether adding nicotine replacement therapy (NRT) to cognitive-behavioral therapy (CBT) for pregnant smokers increases rates of smoking cessation.<h4>Methods</h4>An open-label randomized trial (Baby Steps, n=181) of CBT-only versus CBT+NRT (choice of patch, gum, or lozenge; 1:2 randomization) was used. Data were collected from 2003 through 2005; analyses were conducted in 2006 and 2007. Outcomes were biochemically validated self-reported smoking status at 7 ...[more]

PMID: 17888856

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Project description:Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR).A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures.The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups.Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy.ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011.

Project description:IntroductionThe QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service.MethodsQuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an NVP. Treatment adherence and acceptability, self-reported abstinence, cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms were assessed at 6 and 12 weeks. Results are reported for complete cases and for abstinence outcomes, penalized imputation results are reported where missing is assumed smoking.ResultsRetention on was 63% at 6 weeks and 50% at 12 weeks. At 12 weeks, 68% of the NRT group reported using combination NRT while 96% of the NVP group used the device. Acceptability ratings for the products were high in both groups. At 12 weeks, 14% of the NVP group and 18% of the NRT group reported not smoking at all in the last 7 days. Mean CPD among continued smokers decreased significantly between baseline to 12 weeks in both groups; from 19.91 to 4.72 for the NVP group (p < .001) and from 20.88 to 5.52 in the NRT group (p < .001). Cravings and withdrawal symptoms significantly decreased for both groups.ConclusionsClients completing residential withdrawal readily engaged with smoking cessation post-treatment when given the opportunity. Further research is required to identify the most effective treatments postwithdrawal for this population at elevated risk of tobacco-related harm.Trial registration numberACTRN12617000849392.ImplicationsThis pilot study showed that smoking cessation support involving options for nicotine replacement and Quitline-delivered cognitive behavioral counseling is attractive to people after they have been discharged from SUD treatment. Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked. Some participants self-reported abstinence from cigarettes-around one in five reported having quit smoking cigarettes at 12 weeks postdischarge. The results have significant public health implications for providing quit support following discharge from SUD treatment.

Dataset Information

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

Background

Methods

Results

Conclusions

Publications

Nicotine replacement and behavioral therapy for smoking cessation in pregnancy.

Similar Datasets

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