New Biomarkers Based on Smoking-Related Phenotypes for Smoking Cessation Outcomes of Nicotine Replacement Therapy: A Prospective Study

Introduction: Identification of a potent biomarker related to smoking cessation can play a key role in predicting prognosis and improving treatment outcomes. This study aimed to evaluate the contribution of new biomarkers based on levels of cotinine (Cot) and/or carbon monoxide (CO) to the short- and long-term quit rates of nicotine replacement therapies (nicotine patch (NP) and nicotine lozenge (NL)). Methods: In this prospective interventional study, a sample of 124 smokers under treatment with the 5A's method was selected between April 2016 and December 2018 in an outpatient smoking cessation center in 18th region of Tehran. They were divided into two groups for NP (n = 56) and NL (n = 61) interventions. The levels of Cot and CO were measured using ELISA and breath analysis at the beginning of the study. Three markers were calculated: Cot/CO, Cot to cigarette per day ratio (Cot/CPD), and CO/CPD. To determine the odds of smoking cessation success, binary logistic regression models and generalized estimating equations (GEE) model were analyzed by SPSS software. Results: Of the NP participants, 30.4% and 19.6% were abstinent in 2 and 6 months respectively, while NL was found less effective with 19.7% for 2-month follow-up and 13.1% for 6-month follow-up. The 6-month success of attempts to quit was significantly different for the NP participants at the second half of Cot/CO (P = 0.029). In the NL participants, CO/CPD would be a superior predictor for the success of smoking cessation (P > 0.05). Conclusions: The findings of this study suggested two markers, Cot/CO and CO/CPD in order, for the optimum treatment outcomes of NP and NL.

Anxiety Sensitivity and Distress Tolerance in Smokers: Relations With Tobacco Dependence, Withdrawal, and Quitting Success†

Introduction This study examined relations of two affective vulnerabilities, high anxiety sensitivity (AS) and low distress tolerance (DT), with tobacco dependence, withdrawal, smoking cessation, and pharmacotherapy response. Methods Smokers interested in quitting (N = 1067; 52.2% female, 28.1% African American) were randomized to 12 weeks of nicotine patch, nicotine patch plus nicotine lozenge, or varenicline. Baseline questionnaires assessed AS, DT, negative affect, anxiety, and dependence. Withdrawal was assessed the first-week post-quit via ecological momentary assessment. Results DT, but not AS, predicted biochemically confirmed point-prevalence abstinence at multiple endpoints: weeks 4, 12, 26, and 52 post-quit (ps < .05); relations remained after controlling for pharmacotherapy treatment, AS, baseline negative affect, anxiety, and anxiety disorder history (ps < .05). Additional exploratory analyses examining week 4 abstinence showed DT predicted abstinence (p = .004) even after controlling for baseline dependence, post-quit withdrawal (craving and negative affect), and treatment. DT moderated treatment effects on abstinence in exploratory analyses (interaction p = .025); those with high DT were especially likely to be abstinent at week 4 with patch plus lozenge versus patch alone. Conclusions DT, but not AS, predicted abstinence over 1 year post-quit (higher DT was associated with higher quit rates), with little overlap with other affective measures. DT also predicted early abstinence independent of dependence and withdrawal symptoms. Results suggest low DT may play a meaningful role in motivation to use tobacco and constitute an additional affective risk factor for tobacco cessation failure beyond negative affect or clinical affective disorders. Implications People in a stop-smoking study who reported a greater ability to tolerate distress were more likely to quit smoking and remain smoke-free 1 year later. Smokers with high DT were more likely to be smoke-free 4 weeks after their target quit day if they received nicotine patch plus nicotine lozenge rather than nicotine patch alone. Trial Registration NCT01553084.

Triple Smoking Cessation Therapy with Varenicline, Nicotine Patch and Nicotine Lozenge: A Pilot Study to Assess Tolerability, Satisfaction and End-of-Treatment Quit Rates

Introduction: The majority of attempts to stop smoking end in failure. One way to improve success may be to explore different combinations of existing cessation medications.Aims: This observational study examined ‘triple therapy’ (varenicline + nicotine patch + nicotine lozenge) in 36 smokers trying to quit.Methods: A 12-week, observational study exploring tolerability, via adverse events (AEs) elicited at each of nine phone assessments. Secondary outcomes included satisfaction rates, medication changes and self-reported quit rates at week 12.Results: Thirty five of thirty six participants reported at least one AE. Insomnia (75%), abnormal dreams (72%) and nausea (64%) were most common. Most were mild to moderate. No deaths, hospitalisations, cardiovascular events or suicidality were reported. Six participants (17%) decreased the dose of at least one medication, 5 (14%) decreased the dose then discontinued at least one medication and 13 (36%) discontinued at least one medication without trying a lesser dose. Participants were highly satisfied with their medications, and 58% reported quitting at 12 weeks, with 38% reporting prolonged abstinence.Conclusions: Despite high rates of AEs and medication changes, high rates of satisfaction and self-reported quitting, with no serious AEs, were observed with triple therapy. Additional data on tolerability and efficacy are needed.Trial Registration:Clinicaltrials.gov number NCT02681510.