Dataset Information

Placebo-controlled trial of bupropion for smoking cessation in pregnant women.

ABSTRACT:

Background

Although a relatively small proportion of women who become pregnant continue to smoke cigarettes, no smoking cessation medication has been shown to be effective for this subgroup of smokers. Bupropion, a nonnicotine-based medication, is approved for the promotion of smoking cessation in nonpregnant individuals. We chose to study it in pregnant smokers because, although pregnancy increases nicotine metabolism, it does not affect the metabolism of bupropion.

Objective

We evaluated the efficacy and safety of sustained-release bupropion for smoking cessation among pregnant women.

Study design

We conducted a multiple site, placebo-controlled, randomized clinical trial of bupropion for tobacco use among pregnant women (N=129) (clinical trial number NCT02188459). We enrolled women during the second trimester and randomly assigned them to receive 10 weeks of treatment with either bupropion or placebo, accompanied by a total of 6 smoking cessation counseling sessions (4 during treatment and 2 postpartum). The primary outcome was 7-day point prevalence smoking abstinence, confirmed with breath carbon monoxide measurements, at the end of treatment (week 10) and at week 24. Group differences were assessed as a binary abstinence outcome using a repeated measure generalized estimating equations model with a logit link. Prolonged abstinence and smoking rates were secondary outcomes. Safety measures included maternal treatment-related adverse events, gestational age, the rate of overall and spontaneous preterm births and infant birthweight and size for gestational age, head circumference, and 5-minute Apgar scores.

Results

There were no significant differences in the safety measures across the treatment arms and bupropion was not efficacious in promoting smoking cessation at the end of treatment (7-day point prevalence quit rates: bupropion, 11.0%; placebo, 18.5%) or week 24 (7-day point prevalence quit rates: bupropion, 9.4%; placebo, 21.5%) (P>.05). African American women and women with a lower severity of nicotine dependence had significantly higher quit rates overall and women with an opioid use disorder who were being treated with opioid agonist therapy had significantly lower quit rates overall, irrespective of the treatment group (all P values <.05).

Conclusion

Although bupropion use was not associated with an elevated risk for pregnancy complications when initiated in the second trimester, it did not increase the likelihood of smoking cessation in this cohort of pregnant women. Because smoking is the major preventable source of poor pregnancy outcomes and psychosocial interventions have only modest beneficial effects, additional studies are needed to identify safe and efficacious smoking cessation medications for pregnant women who continue to smoke.

SUBMITTER: Kranzler HR

PROVIDER: S-EPMC8295398 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.

Project description:Previous research demonstrated the efficacy of sustained release bupropion (bupropion SR) for smoking cessation in whites as well as moderate to heavy (?10 cigarettes per day [CPD]) African American smokers. We evaluated whether bupropion SR was effective for smoking cessation among African American light smokers (?10 CPD).A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African American light smokers (?10 CPD), aged 18 years or older. Participants were randomly assigned to receive 300 mg bupropion SR (150 mg once daily for 3 days and then 150 mg twice daily) (n = 270 participants) or placebo (n = 270 participants) for 7 weeks, and up to six sessions of health education counseling. Serum cotinine was measured at baseline (week 0). The primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26; a cut point of 15 ng/mL differentiated smokers from nonsmokers. Salivary cotinine-verified smoking abstinence at end of medication treatment at week 7 was also examined. Odds ratios (OR) for smoking abstinence and 95% confidence intervals (CIs) were calculated using logistic regression models. All statistical tests were two-sided.Participants at baseline visit (week 0) smoked an average of 8.0 CPD and had a mean serum cotinine level of 275.8 ng/mL (SD = 155.8 ng/mL); most used menthol cigarettes (83.7%) and smoked within 30 minutes of waking (72.2%). After imputing those lost to follow-up as smokers, no statistically significant difference in long-term smoking abstinence rates at week 26 was observed between bupropion SR and placebo groups (13.3% vs 10.0%, OR = 1.39, 95% CI = 0.82 to 2.35, P = .23). Cotinine-verified smoking abstinence rate at end of medication week 7 was higher in the bupropion SR vs placebo group (23.7% vs 9.6%, OR = 2.92, 95% CI = 1.78 to 4.77, P < .001).Bupropion SR was effective in promoting smoking cessation during the medication phase of treatment but showed no effect on long-term smoking cessation among African American light smokers. More research is needed to identify strategies for sustaining abstinence among African American light smokers.

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