Dataset Information

Evaluating the impact of varying expired carbon monoxide thresholds on smoking relapse identification: insights from the E3 trial on e-cigarette efficacy for smoking cessation.

ABSTRACT:

Objectives

Expired carbon monoxide (ECO) is often used in smoking cessation trials to biochemically validate self-reported smoking status. The optimal ECO threshold to distinguish individuals who smoke from those who do not is debated.

Design

The data from the 'Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) Trial' were used; the E3 trial was a randomised controlled trial that examined e-cigarettes efficacy for smoking cessation.

Settings

Participants were recruited from 17 Canadian sites across 4 provinces.

Participants

This substudy included data from participants who returned for at least one of the clinical visits at week 4 (291), 12 (257) or 24 (218) and provided both self-reported smoking status and ECO measures. Analyses were based on 766 paired measures (ie, self-reported smoking status with corresponding ECO).

Results

The ability of ECO measurements to discriminate between adults who reported smoking and those who reported abstinence varied with the threshold used. ECO thresholds of 6, 7, 8 and 9 parts per million (ppm) yielded the greatest area under the receiver operating characteristic curve (0.84). These thresholds produced sensitivities of 84%, 82%, 78% and 76% and specificities of 84%, 87%, 90% and 91%, respectively. However, at a threshold of 6 ppm, intersecting sensitivity (84%) and specificity (84%) were maximised with respect to each other. Biochemical validation had the highest agreement with self-report at an ECO threshold of 6 ppm (κ=0.57; 95% CI, 0.51 to 0.64).

Conclusion

The classification of participants' smoking status depends on the ECO threshold used for biochemical validation. We recommend that future smoking cessation trial investigators analyse and report the impact that varying ECO thresholds has on trial results.

Trial registration number

NCT02417467.

SUBMITTER: Prell C

PROVIDER: S-EPMC10583027 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Evaluating the impact of varying expired carbon monoxide thresholds on smoking relapse identification: insights from the E3 trial on e-cigarette efficacy for smoking cessation.

Prell Celine C Hébert-Losier Andréa A Filion Kristian B KB Reynier Pauline P Eisenberg Mark J MJ

BMJ open 20231013 10

<h4>Objectives</h4>Expired carbon monoxide (ECO) is often used in smoking cessation trials to biochemically validate self-reported smoking status. The optimal ECO threshold to distinguish individuals who smoke from those who do not is debated.<h4>Design</h4>The data from the 'Evaluating the Efficacy of E-Cigarette use for Smoking Cessation (E3) Trial' were used; the E3 trial was a randomised controlled trial that examined e-cigarettes efficacy for smoking cessation.<h4>Settings</h4>Participants ...[more]

PMID: 37832989

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Project description:BackgroundAlcohol and nicotine dependence frequently co-occur, and quitting smoking might enhance long-term alcohol abstinence. Topiramate appears to help non-alcohol-dependent individuals quit smoking, and our pilot work suggested efficacy only in men. It also prevents relapse to alcohol in recently detoxified alcoholics. We evaluated topiramate in abstinent alcohol-dependent men to assess whether this medication (i) promotes smoking cessation and (ii) prevents alcohol and other drug relapse in the context of smoking cessation treatment.MethodsOne hundred and twenty-nine alcohol-abstinent (mean ~6 months) alcohol-dependent male smokers (80% with other substance use disorders) participated in this 12-week randomized, double blind, parallel group comparison of topiramate (up to 200 mg/d) and placebo with a 24-week nontreatment follow-up period. The study was carried out sequentially at 2 academic centers in the Midwest and Southern California between March 23, 2009 and November 20, 2014. All participants received manual-guided smoking cessation counseling combined with medication-focused compliance enhancement therapy. Randomization was block designed by the research pharmacist in a 1:1 ratio. Participants, investigators, and research personnel were masked to treatment assignment. The primary smoking end point was biochemically confirmed 4-week continuous abstinence from smoking during weeks 9 to 12, while the secondary end point was relapse to any drinking or drug use during the entire 36-week evaluation period. Logistic regression was used to determine the effects of topiramate on quitting smoking and alcohol relapse, controlling for relevant covariates. The trial is registered at ClinicalTrials.gov (number NCT00802412) and is now closed.ResultsOnly a small proportion (7.9%) of topiramate-treated participants were able to quit smoking, and this cessation rate was similar to placebo (10.6%; odds ratio = 1.60; 95% confidence interval 0.4, 6.5; p = 0.51). Roughly 30% of the sample had a documented relapse to drinking or drug use during the study, and these rates were similar in the topiramate (20/63; 31.8%) and placebo groups (18/66; 27.3%; p = 0.58). Results of a longitudinal logistic regression model examining time to any alcohol relapse revealed no medication effect.ConclusionsTopiramate at a daily dosage of up to 200 mg per day, combined with smoking cessation and medication adherence counseling, had no effects on smoking cessation or the prevention of alcohol or drug relapse in male smokers who were in early or sustained full remission from alcohol and motivated to make a quit attempt. Alternative approaches for treating this high-risk, dually dependent population are needed.

Dataset Information

Evaluating the impact of varying expired carbon monoxide thresholds on smoking relapse identification: insights from the E3 trial on e-cigarette efficacy for smoking cessation.

Objectives

Design

Settings

Participants

Results

Conclusion

Trial registration number

Publications

Evaluating the impact of varying expired carbon monoxide thresholds on smoking relapse identification: insights from the E3 trial on e-cigarette efficacy for smoking cessation.

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