Dataset Information

QuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification.

ABSTRACT:

Introduction

The QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service.

Methods

QuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an NVP. Treatment adherence and acceptability, self-reported abstinence, cigarettes smoked per day (CPD), frequency of cravings, and severity of withdrawal symptoms were assessed at 6 and 12 weeks. Results are reported for complete cases and for abstinence outcomes, penalized imputation results are reported where missing is assumed smoking.

Results

Retention on was 63% at 6 weeks and 50% at 12 weeks. At 12 weeks, 68% of the NRT group reported using combination NRT while 96% of the NVP group used the device. Acceptability ratings for the products were high in both groups. At 12 weeks, 14% of the NVP group and 18% of the NRT group reported not smoking at all in the last 7 days. Mean CPD among continued smokers decreased significantly between baseline to 12 weeks in both groups; from 19.91 to 4.72 for the NVP group (p < .001) and from 20.88 to 5.52 in the NRT group (p < .001). Cravings and withdrawal symptoms significantly decreased for both groups.

Conclusions

Clients completing residential withdrawal readily engaged with smoking cessation post-treatment when given the opportunity. Further research is required to identify the most effective treatments postwithdrawal for this population at elevated risk of tobacco-related harm.

Trial registration number

ACTRN12617000849392.

Implications

This pilot study showed that smoking cessation support involving options for nicotine replacement and Quitline-delivered cognitive behavioral counseling is attractive to people after they have been discharged from SUD treatment. Both nicotine vaping products and nicotine replacement therapies were highly acceptable and used by participants who reported reductions in cravings for cigarettes and perceptions of withdrawal symptoms and reductions in number of cigarettes smoked. Some participants self-reported abstinence from cigarettes-around one in five reported having quit smoking cigarettes at 12 weeks postdischarge. The results have significant public health implications for providing quit support following discharge from SUD treatment.

SUBMITTER: Bonevski B

PROVIDER: S-EPMC7885782 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

QuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification.

Bonevski Billie B Manning Victoria V Wynne Olivia O Gartner Coral C Borland Ron R Baker Amanda L AL Segan Catherine J CJ Skelton Eliza E Moore Lyndell L Bathish Ramez R Chiu Simon S Guillaumier Ashleigh A Lubman Dan I DI

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20210201 3

<h4>Introduction</h4>The QuitNic pilot trial aimed to test the feasibility of providing a nicotine vaping product (NVP) compared with combination nicotine replacement therapy (NRT) to smokers upon discharge from a smoke-free residential substance use disorder (SUD) treatment service.<h4>Methods</h4>QuitNic was a pragmatic two-arm randomized controlled trial. At discharge from residential withdrawal, 100 clients received telephone Quitline behavioral support and either 12-week supply of NRT or an ...[more]

PMID: 32770246

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Project description:ObjectivesDespite the aggressive marketing of electronic nicotine device systems (ENDS) as smoking cessation tools, the evidence of their effectiveness is mixed. We conducted a systematic review of randomised controlled trials to determine the effect of ENDS on cigarette smoking cessation, as compared with other types of nicotine replacement therapies (NRT).DesignSystematic review and meta-analysis using the Grading of Recommendations Assessment, Development and Evaluation approach.Data sourcesMEDLINE, Embase, the CENTRAL Trials Registry of the Cochrane Collaboration using the Ovid interface, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform trials registries were searched through 17 June 2020.Eligibility criteria for studiesRandomised controlled trials in which any type of ENDS was compared with any type of NRT, in traditional cigarette users.Data extraction and synthesisThe primary outcome was smoking cessation, defined as abstinence from traditional cigarette smoking for any time period, as reported in each included study, regardless of whether abstinence is self-reported or biochemically validated. Secondary outcomes included smoking reduction, harms, withdrawal and acceptance of therapy. A random-effect model was used, and data were pooled in meta-analyses where appropriate.ResultsSix studies were retained from 270. Most outcomes were judged to be at high risk of bias. The overall quality of evidence was graded as 'low' or 'very low'. Pooled results showed no difference in smoking cessation (rate ratio (RR) 1.42, 95% CI 0.97 to 2.09), proportion of participants reducing smoking consumption (RR 1.25, 95% CI 0.79 to 1.98), mean reduction in cigarettes smoked per day (mean difference 1.11, 95% CI -0.41 to 2.63), or harms (RR 0.96, 95% CI 0.76 to 1.20), between groups.ConclusionWe found no difference in smoking cessation, harms and smoking reduction between e-cigarette and NRT users. However, the quality of the evidence was low. Further research is needed before widespread recommendations are made with regard to the use of ENDS.Prospero registration numberSystematic review registration number: protocol registered with the International Prospective Register of Systematic Reviews (PROSPERO) on February 27th, 2020; CRD42020169416.

Project description:BackgroundCigarette smoking remains the leading cause of preventable illness and death, underscoring ongoing need for evidence-based solutions. Pivot, a US Clinical Practice Guideline-based mobile smoking cessation program, comprises a personal carbon monoxide breath sensor; a smartphone app; in-app, text-based human-provided coaching; nicotine replacement therapy; and a moderated web-based community. Promising Pivot cohort studies have established the foundation for comparative assessment.ObjectiveThis study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide, a US Clinical Practice Guideline-based smoking cessation smartphone app from the National Cancer Institute.MethodsIn this remote pilot randomized controlled trial, cigarette smokers in the United States were recruited on the web and randomized to Pivot or QuitGuide. Participants were offered 12 weeks of free nicotine replacement therapy. Data were self-reported via weekly web-based questionnaires for 12 weeks and at 26 weeks. Outcomes included engagement and retention, attitudes toward quitting smoking, smoking behavior, and participant feedback. The primary outcome was self-reported app openings at 12 weeks. Cessation outcomes included self-reported 7- and 30-day point prevalence abstinence (PPA), abstinence from all tobacco products, and continuous abstinence at 12 and 26 weeks. PPA and continuous abstinence were biovalidated via breath carbon monoxide samples.ResultsParticipants comprised 188 smokers (94 Pivot and 94 QuitGuide): mean age 46.4 (SD 9.2) years, 104 (55.3%) women, 128 (68.1%) White individuals, and mean cigarettes per day 17.6 (SD 9.0). Engagement via mean "total app openings through 12 weeks" (primary outcome) was Pivot, 157.9 (SD 210.6) versus QuitGuide, 86.5 (SD 66.3; P<.001). Self-reported 7-day PPA at 12 and 26 weeks was Pivot, 35% (33/94) versus QuitGuide, 28% (26/94; intention to treat [ITT]: P=.28) and Pivot, 36% (34/94) versus QuitGuide, 27% (25/94; ITT: P=.12), respectively. Self-reported 30-day PPA at 12 and 26 weeks was Pivot, 29% (27/94) versus QuitGuide, 22% (21/94; ITT: P=.32) and Pivot, 32% (30/94) versus QuitGuide, 22% (21/94; ITT: P=.12), respectively. The biovalidated abstinence rate at 12 weeks was Pivot, 29% (27/94) versus QuitGuide, 13% (12/94; ITT: P=.008). Biovalidated continuous abstinence at 26 weeks was Pivot, 21% (20/94) versus QuitGuide, 10% (9/94; ITT: P=.03). Participant feedback, including ease of setup, impact on smoking, and likelihood of program recommendation were favorable for Pivot.ConclusionsIn this randomized controlled trial comparing the app-based smoking cessation programs Pivot and QuitGuide, Pivot participants had higher engagement and biovalidated cessation rates and more favorable user feedback at 12 and 26 weeks. These findings support Pivot as an effective, durable mobile smoking cessation program.Trial registrationClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Project description:Introduction:Varenicline doubles cessation over nicotine replacement therapy (NRT) patch for "normal," but not "slow," nicotine metabolizers, as assessed by the nicotine metabolite ratio (NMR). Metabolism-informed care (MIC) could improve outcomes by matching normal metabolizers with non-nicotine medication (e.g., varenicline) and slow metabolizers with NRT patch. Methods:We conducted a feasibility randomized controlled trial of MIC versus guideline based care (GBC) among 81 outpatient adult daily smokers with medical comorbidity. Participants reported perceptions of MIC, underwent blood draw for NMR, and received expert cessation counseling. For MIC participants, medication selection was informed by NMR result (normal (?0.31) vs. slow (< 0.31)). The primary outcome was MIC feasibility, reflected by attitudes toward MIC and by match rates between NMR and medication. Secondary endpoints (cessation confidence, medication use, smoking status) were assessed over 6 months to inform future studies. Results:Participants were median age 53 years, 46% female, 28% black, and ~90% endorsed MIC. Despite high varenicline prescription rates (~60%) in both arms, NMR-medication matching was higher in MIC (84%) versus GBC (58%) participants (p=0.02); unadjusted odds ratio (OR) 3.67, 95% confidence interval [1.33, 11.00; p-value=0.02]. Secondary endpoints were similar at 1, 3, and 6 months. Conclusions:MIC, an NMR-based precision approach to smoking cessation, was acceptable to 90% of smokers and improved NMR-medication match rates more than 3-fold compared to GBC, even with generally high use of varenicline. These data support the feasibility of MIC, which could maximize efficacy of smoking cessation medication while minimizing side effects and cost. Implications:Among treatment-seeking daily smokers with medical comorbidity, most viewed metabolism-informed care (MIC), guided by the nicotine metabolism ratio (NMR), favorably, and were willing to accept MIC-guided medication. Compared to GBC participants (58%), more MIC participants (84%) were prescribed NMR-matched medication (i.e., normal metabolizers received varenicline; slow metabolizers received NRT patch). MIC increased the odds of optimized matching between NMR and medication more than 3-fold over GBC. Because the number needed to treat (NNT) to help one normal metabolizer quit smoking is only 4.9 for varenicline versus 26 for patch, broad implementation of MIC will improve drug efficacy in normal metabolizers as well as minimize side effects in slow metabolizers.

Project description:BACKGROUND AND AIMS:Debate exists about whether health professionals (HPs) should advise smokers to use nicotine vaping products (NVPs) to quit smoking. The objectives were to examine in four countries: (1) the prevalence of HP discussions and recommendations to use an NVP; (2) who initiated NVP discussions; (3) the type of HP advice received about NVPs; and (4) smoker's characteristics related to receiving advice about NVPs. DESIGN:Cross-sectional study using multivariable logistic regression analyses on weighted data from the 2016 ITC Four Country Smoking and Vaping Survey (ITC 4CV1). SETTING:Four countries with varying regulations governing the sale and marketing of NVPs: 'most restrictive' (Australia), 'restrictive' (Canada) or 'less restrictive' (England and United States). PARTICIPANTS:A total of 6615 adult smokers who reported having visited an HP in the last year (drawn from the total sample of 12 294 4CV1 respondents, of whom 9398 reported smoking cigarettes daily or weekly). Respondents were from the United States (n = 1518), England (n = 2116), Australia (n = 1046), and Canada (n = 1935). MEASUREMENTS:Participants' survey responses indicated if they were current daily or weekly smokers and had visited an HP in the past year. Among those participants, further questions asked participants to report (1) whether NVPs were discussed, (2) who raised the topic, (3) advice received on use of NVPs and (4) advice received on quitting smoking. FINDINGS:Among the 6615 smokers who visited an HP in the last year, 6.8% reported discussing NVPs with an HP and 2.1% of smokers were encouraged to use an NVP (36.1% of those who had a discussion). Compared with Australia (4.3%), discussing NVPs with an HP was more likely in the United States [8.8%, odds ratio (OR) = 2.15, 95% confidence interval (CI) = 1.41-3.29] and Canada (7.8%, OR = 1.87, 95% CI = 1.26-2.78). Smokers in Australia were less likely to discuss NVPs than smokers in England (6.2%), although this was not statistically significant (OR = 1.47, 95% CI = 0.98-2.20). Overall, the prevalence of HPs recommending NVPs was three times more likely in the United States than in Australia (OR = 3.07, 95% CI = 1.45-6.47), and twice as likely in Canada (OR = 2.28, 95% CI = 1.06-4.87) than in Australia. Australia and England did not differ (OR = 1.76, 95% CI = 0.83-3.74). Just over half (54%) of respondents brought up NVPs themselves; there were no significant differences among countries. CONCLUSIONS:Discussions in Australia, Canada, England, and the United States between smokers and health professionals about nicotine vaping products appear to be infrequent, regardless of the regulatory environment. A low percentage of health professionals recommended vaping products. This was particularly evident in Australia, which has the most restrictive regulatory environment of the four countries studied.

Dataset Information

QuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification.

Introduction

Methods

Results

Conclusions

Trial registration number

Implications

Publications

QuitNic: A Pilot Randomized Controlled Trial Comparing Nicotine Vaping Products With Nicotine Replacement Therapy for Smoking Cessation Following Residential Detoxification.

Similar Datasets

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