Dataset Information

Bupropion for smoking cessation in African American light smokers: a randomized controlled trial.

ABSTRACT:

Background

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).

Methods

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.

Results

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).

Conclusions

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.

SUBMITTER: Cox LS

PROVIDER: S-EPMC3283533 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Publications

Bupropion for smoking cessation in African American light smokers: a randomized controlled trial.

Cox Lisa Sanderson LS Nollen Nicole L NL Mayo Matthew S MS Choi Won S WS Faseru Babalola B Benowitz Neal L NL Tyndale Rachel F RF Okuyemi Kolawole S KS Ahluwalia Jasjit S JS

Journal of the National Cancer Institute 20120125 4

<h4>Background</h4>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).<h4>Methods</h4>A randomized, double-blind placebo-controlled trial was conducted from December 27, 2007, to May 13, 2010. All participants were African Ame ...[more]

PMID: 22282543

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Project description:This is the first study to examine predictors of successful cessation in African American (AA) light smokers treated within a placebo-controlled trial of bupropion.We analyzed data from a randomized, double-blind, placebo-controlled trial of bupropion and health education for 540 African American light smokers. African American light smokers (?10 cigarettes per day, cpd) were randomly assigned to receive 150mg bid bupropion SR (n=270) or placebo (n=270) for 7weeks. All participants received health education counseling at weeks 0, 1, 3, 5 and 7. Using chi-square tests, two sample t-tests, and multiple logistic regression analyses, we examined baseline psychosocial and smoking characteristics as predictors of cotinine-verified 7-day point prevalence smoking abstinence among study participants at the end treatment (Week 7) and at the end of follow-up (Week 26).Participants who received bupropion were significantly more likely to quit smoking compared to those who received placebo (OR=2.72, 95% CI=1.60-4.62, P=0.0002). Greater study session attendance (OR=2.47, 95% CI=1.76-3.46, P=0.0001), and smoking non-menthol cigarettes increased the likelihood of quitting (OR=1.84, 95% CI=1.01-3.36, P=0.05); while longer years of smoking (OR=0.98, 95% CI=0.96-1.00, P=0.05) and higher baseline cotinine (OR=0.97, 95% CI=0.95-0.99, P=0.002) significantly reduced the odds of quitting at Week 7. Conversely, at the end of follow-up (Week 26), treatment with bupropion vs. placebo (OR=1.14, 95% CI=0.65-2.02, P=0.64) was not significantly associated with quitting and type of cigarette smoked (menthol vs. non-menthol) did not appear in the final logistic regression model. Greater study session attendance (OR=1.96, 95% CI=1.44-2.66, P=0.0001); BMI (OR=1.03, 95% CI=1.00-1.07, P=0.04); and weight efficacy (OR=1.03, 95% CI=1.01-1.05, P=0.01) increased the likelihood of quitting at Week 26. Similar to our findings at Week 7, longer years of smoking (OR=0.96, 95% CI=0.94-0.99, P=0.01) and higher baseline cotinine (OR=0.97, 95% CI=0.95-0.99, P=0.02) significantly reduced the odds of quitting at Week 26.Baseline cotinine levels, number of years smoked and study session attendance are associated with both short- and long-term smoking cessation, while bupropion and the type of cigarette smoked were associated with quitting on short term only.

Project description:BackgroundAlthough 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.ObjectiveWe evaluated the efficacy and safety of sustained-release bupropion for smoking cessation among pregnant women.Study designWe 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.ResultsThere 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).ConclusionAlthough 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.

Project description:BackgroundDespite promising data in Western countries, there is a dearth of research into the efficacy of text messaging-based smoking cessation programs in other settings, including the Middle East, where smoking prevalence rates are higher.ObjectiveThis paper reports cessation rates observed in SMS Turkey, a text messaging-based smoking cessation program for adult smokers in Ankara, Turkey.MethodsThis study was a small-scale, parallel-group randomized controlled trial (RCT) conducted in Ankara, Turkey. Participants were adult daily smokers who were seriously thinking about quitting in the next 15 days and living in Ankara, Turkey. The text messaging intervention, SMS Turkey, provided 6 weeks of daily messages aimed at giving participants skills to help them quit smoking. Messages were sent in an automated fashion, except 2 days and 7 days after the initial quit day. On days 2 and 7, the research assistant manually assigned participants to content "paths" based on whether they were still not smoking or had relapsed. The control arm received a brochure that provided similar information about smoking cessation. The main outcome measure was self-reported 3-month sustained abstinence, verified by carbon monoxide (CO) readings. Neither participants nor researchers were blinded to arm assignment.ResultsThe 151 participants were randomly assigned to 1 of 2 groups: 76 to the SMS Turkey intervention group and 75 to the brochure control group. Using intention to treat, all 151 participants were included in analyses. Three-month cessation trends were not significantly higher in the intervention group: 11% intervention vs 5% control had quit (χ(2)(1)=1.4, P=.24; R(2)=2.0, 95% CI 0.62-6.3). When the sample was stratified by sex, female intervention participants (14%, n=5) were significantly more likely to have quit at 3 months than female control participants (0%, n=0; χ(2)(1)=3.7, P=.05). Among light smokers (ie, those smoking less than 20 cigarettes per day), intervention participants (17%, n=5) also were significantly more likely to have quit compared to control participants (0%, n=0; χ(2)(1)=5.3, P=.02). We noted no difference in cessation rates for males or heavy smokers. Participants experienced significant technology problems during the study. Some participants received duplicate text messages at least once during the trial; others failed to receive some program messages. Neither receiving duplicate messages (χ(2)(1)=0.12, P=.73), or missing 5 or more program messages (χ(2)(1)=0.75, P=.39) negatively affected quitting rates.ConclusionsAlthough the study was not powered to detect statistically significant differences, as the primary aim was to provide estimates of effect size that could be used to better inform a power analysis for a larger trial, findings provide optimism that SMS Turkey may be able to affect quitting rates in environments with high smoking prevalence, such as Ankara, Turkey. The SMS Turkey software program did not work as well as it did 2 years previous. The system will need to be updated to maintain software compatibility with ongoing technology evolution.Trial registrationClinicaltrials.gov NCT00912795 http://clinicaltrials.gov/ct2/show/NCT00912795 (Archived by WebCite® at http://www.webcitation.org/6Ch1cIA8l).

Project description:ImportanceAfrican American smokers have among the highest rates of tobacco-attributable morbidity and mortality in the US, and effective treatment is needed for all smoking levels.ObjectivesTo evaluate the efficacy of varenicline vs placebo among African American adults who are light, moderate, and heavy daily smokers.Design, setting, and participantsThe Kick It at Swope IV (KIS-IV) trial was a randomized, double-blind, placebo-controlled clinical trial conducted at a federally qualified health center in Kansas City. A total of 500 African American adults who were daily smokers of all smoking levels were enrolled from June 2015 to December 2017; final follow-up was completed in June 2018.InterventionsParticipants were provided 6 sessions of culturally relevant individualized counseling and were randomized (in a 3:2 ratio) to receive varenicline (1 mg twice daily; n = 300) or placebo (n = 200) for 12 weeks. Randomization was stratified by sex and smoking level (1-10 cigarettes/d [light smokers] or >10 cigarettes/d [moderate to heavy smokers]).Main outcomes and measuresThe primary outcome was salivary cotinine-verified 7-day point prevalence smoking abstinence at week 26. The secondary outcome was 7-day point prevalence smoking abstinence at week 12, with subgroup analyses for light smokers (1-10 cigarettes/d) and moderate to heavy smokers (>10 cigarettes/d).ResultsAmong 500 participants who were randomized and completed the baseline visit (mean age, 52 years; 262 [52%] women; 260 [52%] light smokers; 429 [86%] menthol users), 441 (88%) completed the trial. Treating those lost to follow-up as smokers, participants receiving varenicline were significantly more likely than those receiving placebo to be abstinent at week 26 (15.7% vs 6.5%; difference, 9.2% [95% CI, 3.8%-14.5%]; odds ratio [OR], 2.7 [95% CI, 1.4-5.1]; P = .002). The varenicline group also demonstrated greater abstinence than the placebo group at the end of treatment week 12 (18.7% vs 7.0%; difference, 11.7% [95% CI, 6.0%-17.7%]; OR, 3.0 [95% CI, 1.7-5.6]; P < .001). Smoking abstinence at week 12 was significantly greater for individuals receiving varenicline compared with placebo among light smokers (22.1% vs 8.5%; difference, 13.6% [95% CI, 5.2%-22.0%]; OR, 3.0 [95% CI, 1.4-6.7]; P = .004) and among moderate to heavy smokers (15.1% vs 5.3%; difference, 9.8% [95% CI, 2.4%-17.2%]; OR, 3.1 [95% CI, 1.1-8.6]; P = .02), with no significant smoking level × treatment interaction (P = .96). Medication adverse events were generally comparable between treatment groups, with nausea reported more frequently in the varenicline group (163 of 293 [55.6%]) than the placebo group (90 of 196 [45.9%]).Conclusions and relevanceAmong African American adults who are daily smokers, varenicline added to counseling resulted in a statistically significant improvement in the rates of 7-day point prevalence smoking abstinence at week 26 compared with counseling and placebo. The findings support the use of varenicline in addition to counseling for tobacco use treatment among African American adults who are daily smokers.Trial registrationClinicalTrials.gov Identifier: NCT02360631.

Dataset Information

Bupropion for smoking cessation in African American light smokers: a randomized controlled trial.

Background

Methods

Results

Conclusions

Publications

Bupropion for smoking cessation in African American light smokers: a randomized controlled trial.

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