Dataset Information

Extended treatment for cigarette smoking cessation: a randomized control trial.

ABSTRACT:

Aim

To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking.

Design

Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT (n = 111) or extended CBT (n = 112) following a 26-week open-label treatment.

Setting

Community clinic in the United States.

Participants

A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18).

Intervention

All participants received 10 weeks of combined CBT + bupropion sustained release (bupropion SR) + nicotine patch and were continued on CBT and either no medications if abstinent, continued bupropion + nicotine replacement therapy (NRT) if increased craving or depression scores, or varenicline if still smoking at 10 weeks. Half the participants were randomized at 26 weeks to extended CBT (E-CBT) to week 48 and half to non-extended CBT (no additional CBT sessions).

Measurements

The primary outcome was expired CO-confirmed, 7-day point-prevalence (PP) at 52- and 104-week follow-up. Analyses were based on intention-to-treat.

Findings

PP abstinence rates at the 52-week follow-up were comparable across non-extended CBT (40%) and E-CBT (39%) groups [odds ratio (OR) = 0.99; 95% confidence interval (CI) = 0.55, 1.78]. A similar pattern was observed across non-extended CBT (39%) and E-CBT (33%) groups at the 104-week follow-up (OR = 0.79; 95% CI= 0.44, 1.40).

Conclusion

Prolonging cognitive-behavioral therapy from 26 to 48 weeks does not appear to improve long-term abstinence from smoking.

SUBMITTER: Laude JR

PROVIDER: S-EPMC5503769 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

Extended treatment for cigarette smoking cessation: a randomized control trial.

Laude Jennifer R JR Bailey Steffani R SR Crew Erin E Varady Ann A Lembke Anna A McFall Danielle D Jeon Anna A Killen Diana D Killen Joel D JD David Sean P SP

Addiction (Abingdon, England) 20170502 8

<h4>Aim</h4>To test the potential benefit of extending cognitive-behavioral therapy (CBT) relative to not extending CBT on long-term abstinence from smoking.<h4>Design</h4>Two-group parallel randomized controlled trial. Patients were randomized to receive non-extended CBT (n = 111) or extended CBT (n = 112) following a 26-week open-label treatment.<h4>Setting</h4>Community clinic in the United States.<h4>Participants</h4>A total of 219 smokers (mean age: 43 years; mean cigarettes/day: 18).<h4>In ...[more]

PMID: 28239942

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Project description:It is well established in studies across several countries that tobacco smoking is more prevalent among schizophrenic patients than the general population. Electronic cigarettes are becoming increasingly popular with smokers worldwide. To date there are no large randomized trials of electronic cigarettes in schizophrenic smokers. A well-designed trial is needed to compare efficacy and safety of these products in this special population.We have designed a randomized controlled trial investigating the efficacy and safety of electronic cigarette. The trial will take the form of a prospective 12-month randomized clinical study to evaluate smoking reduction, smoking abstinence and adverse events in schizophrenic smokers not intending to quit. We will also monitor quality of life, neurocognitive functioning and measure participants' perception and satisfaction of the product.A ?50% reduction in the number of cigarettes/day from baseline, will be calculated at each study visit ("reducers"). Abstinence from smoking will be calculated at each study visit ("quitters"). Smokers who leave the study protocol before its completion and will carry out the Early Termination Visit or who will not satisfy the criteria of "reducers" and "quitters" will be defined "non responders".The differences of continuous variables between the three groups will be evaluated with the Kruskal-Wallis Test, followed by the Dunn multiple comparison test. The differences between the three groups for normally distributed data will be evaluated with ANOVA test one way, followed by the Newman-Keuls multiple comparison test. The normality of the distribution will be evaluated with the Kolmogorov-Smirnov test. Any correlations between the variables under evaluation will be assessed by Spearman r correlation. To compare qualitative data will be used the Chi-square test.The main strengths of the SCARIS study are the following: it's the first large RCT on schizophrenic patient, involving in and outpatient, evaluating the effect of a three-arm study design, and a long term of follow-up (52-weeks).The goal is to propose an effective intervention to reduce the risk of tobacco smoking, as a complementary tool to treat tobacco addiction in schizophrenia.ClinicalTrials.gov, NCT01979796.

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Dataset Information

Extended treatment for cigarette smoking cessation: a randomized control trial.

Aim

Design

Setting

Participants

Intervention

Measurements

Findings

Conclusion

Publications

Extended treatment for cigarette smoking cessation: a randomized control trial.

Similar Datasets

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