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Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol.

ABSTRACT: Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.ClinicalTrials.gov: NCT01429129.

SUBMITTER: Cunningham JA

PROVIDER: S-EPMC3198706 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol.

Cunningham John A JA Leatherdale Scott T ST Selby Peter L PL Tyndale Rachel F RF Zawertailo Laurie L Kushnir Vladyslav V

BMC public health 20110928

<h4>Background</h4>Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement ...[more]

PMID: 21955930

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Project description:BackgroundOur group recently completed a randomized controlled trial, evaluating the efficacy of providing 5 weeks of free nicotine replacement therapy (NRT; in the form of the nicotine patch) by expedited postal mail without behavioral assistance to regular adult smokers interested in receiving it. The findings revealed that mailed provision of nicotine patches resulted in more than a doubling of quit rates at a six-month follow-up compared to a no intervention control group. While this trial provided evidence for the effectiveness of mailed nicotine patches in promoting cessation, the findings speak only to the short term effectiveness of this approach. As relapse to smoking is known to occur beyond the 6 month period, it is important to evaluate whether the net benefit of NRT in naturalistic settings can be maintained long-term. The present study aims to perform a 5-year follow-up survey of participants in the original trial to evaluate the long-term effectiveness of mailed NRT.Methods/designTrained interviewers will contact participants in the randomized controlled trial 5 years post-enrollment. A total of 924 participants will be eligible to be contacted. Interviewers will first assess participants' smoking status and their level of nicotine dependence. Participants reporting not currently smoking will be asked whether they have smoked tobacco, even a puff, in the last 30 days (primary outcome measure: 30-day point prevalence abstinence), past 6 months (secondary outcome measure: prolonged 6-month abstinence), and since the 8-week follow-up survey (secondary outcome measure: > 4 year continuous abstinence). Interviewers will be blind to experimental condition at the time the primary outcome measure will be assessed. It is hypothesized that participants who received nicotine patches at baseline will display significantly higher quit rates at the 5-year follow-up as compared to participants who did not receive nicotine patches at baseline.DiscussionIf the study finds that the mailed distribution of free NRT is effective at promoting long-term cessation, it would provide further evidence to move forward with policies designed to make NRT treatment readily and freely available to smokers who request it.Trial registrationClinicalTrials.gov : NCT01429129 , Registered 2 September 2011; NCT03097445 , Registered 25 March 2017.

Project description:IntroductionProactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use.Aims and methodsThis study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA.ResultsOf 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14).ConclusionsProactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence.ImplicationsProactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care.Clinicaltrials.gov identifierNCT03174158.

Project description:ObjectiveTo assess whether offering free mailed nicotine replacement therapy (NRT) and telephone counselling to smokers on elective surgery waiting lists increases quitting before surgery.Design, settingRandomised, controlled trial at Frankston Hospital, a public tertiary referral hospital in Melbourne.ParticipantsAdult smokers added to elective surgery waiting lists for operations at least ten days in the future, 1 April 2019 - 3 April 2020.InterventionIn addition to normal care, intervention participants received a brochure on the risks of low frequency smoking, an offer of Quitline call-back registration, and an offer of mailed NRT according to reported daily smoking: 1-9 cigarettes/day, 2 mg lozenges; 10-15/day, 7-14 mg patches [three weeks] and 2 mg lozenges; > 15/day, 7-21 mg patches [five weeks] and 2 mg lozenges.Main outcome measuresPrimary outcome: quitting at least 24 hours before surgery, verified by exhaled carbon monoxide testing.Secondary outcomesquitting at least four weeks before surgery, adverse events, and (for those who had quit before surgery) abstinence three months after surgery.ResultsOf 748 eligible participants (control, 363; intervention, 385), 516 (69%) had undergone elective surgery when the trial was terminated early (for COVID-19-related reasons) (intervention group, 274; control group, 242). 122 of the 385 intervention participants (32%) had accepted the offer of cessation support. The proportions of intervention participants who quit at least 24 hours before surgery (18% v 9%; odds ratio [OR], 1.97; 95% CI, 1.22-3.15) or at least four weeks before surgery (9% v 4%; OR, 2.20; 95% CI, 1.08-4.50) were larger than for the control group. Three months after surgery, 27 of 58 intervention (47%) and 12 of 25 control participants (48%) who quit before surgery reported not smoking in the preceding seven days. No major adverse events were reported.ConclusionUptake of free mailed NRT and Quitline support by smokers on elective surgery waiting lists was good, and offering additional support was associated with higher proportions of smokers quitting before surgery.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12619000032156 (prospective).

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:BackgroundQuitting smoking is the most effective way of reducing the risk of cancer among smokers. One way of helping people stop smoking is to provide them with free Nicotine Replacement Therapy (NRT), such as when NRT is sent to people by postal mail as part of a mass distribution initiative. Our previous research indicated that there may be a substantial impact on increasing quit rates of a mailed NRT intervention in rural areas. The current research seeks to confirm this finding and to understand the social determinants of health driving these anticipated large effects.Methods/designTelephone numbers will be randomly selected from across rural regions of Canada in order to recruit adult smokers interested in completing a smoking survey and willing to be interviewed again in 6 months. The survey will ask participants about their smoking history, demographic characteristics, and a hypothetical question: would they be interested in receiving nicotine patches if they were provided to them free of charge? Half of the smokers interested in receiving nicotine patches will be selected by chance and offered the NRT package. The other half of smokers will not be offered the nicotine patches. In addition, the municipality where each participant lives will be identified and, once the relevant general population data becomes available, attempts will be made to link participant data to relevant municipal characteristics (e.g., smoking rates, availability of health services). Characteristics of the participants and the municipalities in which they live will be used to explain why the nicotine patch intervention may have a larger impact in some rural regions compared to others.DiscussionThe findings from the proposed RCT are timely and of high relevance as the distribution of nicotine patches has substantial potential to combat the public health problem of cigarette related cancer, other diseases, and premature death from tobacco use. Targeting such tobacco cessation initiatives to rural regions may substantially increase the impact of this intervention, helping to optimize the use of limited prevention resources while aiming to save the maximum number of lives.Clinical trials registrationClinicalTrials.gov NCT04606797 , October, 27, 2020.

Project description:IntroductionMobile instant messaging could deliver real-time, personalized, interactive smoking cessation support. Nicotine replacement therapy (NRT) is effective in increasing quit attempts and abstinence but is underused. We assessed the feasibility of mobile chat-based intervention combined NRT sampling (NRT-S) on abstinence.MethodsIn this two-arm, single-blinded, randomized controlled trial, adult (≥18 years) daily cigarette smokers were proactively recruited from Hong Kong community settings using 'foot-in-the-door' approach during December 2017 to March 2018. All participants received brief advice on quitting, 1-week of NRT-S, active referral to smoking cessation services, and were individually randomized (1:1) at baseline. The intervention group received two months of chat-based support via instant messaging. The control group received general smoking cessation text messages. The primary outcome was smoking abstinence validated by exhaled carbon monoxide (<4 ppm) and salivary cotinine (<10 ng/mL) at 3 and 6 months using intention-to-treat analysis.ResultsA total of 119 participants (80.7% male, 60.5% aged 30-40 years) were randomized and analyzed. Among the 14 and 13 self-reported quitters at 3 and 6 months respectively, only 3 and 1 had biochemical validation. The 3 months validated abstinence rate was 2/62 (intervention) vs 1/57 (control) (AOR=1.07; 95% CI: 0.08-13.65). At 6 months follow-up (68.9% of participants retained), more participants in the intervention group reported quitting (10/62 vs 3/57; AOR=2.83; 95% CI: 0.70-11.30), smoking reduction (20/62 vs 11/57; AOR=1.74; 95% CI: 0.71-4.26), and quit attempts (56/62 vs 44/57; AOR=2.61; 95% CI: 0.88-7.82). Significantly more NRT-S use (39/62 vs 22/57; AOR=2.27; 95% CI: 1.04-4.96) was observed in the intervention group. Participants engaged in mobile chat support (21/62) reported more NRT-S use (76.2% vs 56.1%), although not statistically significant.ConclusionsMobile chat-based support plus NRT-S was feasible and showed preliminary evidence of increased quitting, smoking reduction, quit attempts, and NRT-S use in proactively recruited community smokers.Trial registrationClinicalTrials.gov: NCT03574077.

Project description:BackgroundIncreased smartphone ownership has led to the development of mobile smoking cessation programs. Although the related body of evidence, gathered through the conduct of randomized controlled trials (RCTs), has grown in quality and rigor, there is a need for longer-term data to assess associated smoking cessation durability.ObjectiveThe primary aim was to compare smoking cessation outcomes at 52 weeks in adult smokers randomized to a mobile smoking cessation program, Pivot (intervention), versus QuitGuide (control). The secondary aims included comparison of other smoking-related behaviors, outcomes and participant feedback, and exploratory analyses of baseline factors associated with smoking cessation.MethodsIn this remote pilot RCT, cigarette smokers in the United States were recruited on the web. Participants were offered 12 weeks of free nicotine replacement therapy (NRT). Data were self-reported via a web-based questionnaire with videoconference biovalidation in participants who reported 7-day point-prevalence abstinence (PPA). Outcomes focused on cessation rates with additional assessment of quit attempts, cigarettes per day (CPD), self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire, NRT use, and participant feedback. Cessation outcomes included self-reported 7- and 30-day PPA, abstinence from all tobacco products, and continuous abstinence. PPA and continuous abstinence were biovalidated using witnessed breath carbon monoxide samples. Exploratory post hoc regression analyses were performed to identify baseline variables associated with smoking cessation.ResultsParticipants comprised 188 smokers (n=94, 50% in the Pivot group and n=94, 50% in the QuitGuide group; mean age 46.4, SD 9.2 years; n=104, 55.3% women; n=128, 68.1% White individuals; mean CPD 17.6, SD 9.0). Several cessation rates were higher in the Pivot group (intention to treat): self-reported continuous abstinence was 20% (19/94) versus 9% (8/94; P=.03) for QuitGuide, biochemically confirmed abstinence was 31% (29/94) versus 18% (17/94; P=.04) for QuitGuide, and biochemically confirmed continuous abstinence was 19% (18/94) versus 9% (8/94; P=.046) for QuitGuide. More Pivot participants (93/94, 99% vs 80/94, 85% in the QuitGuide group; P<.001) placed NRT orders (mean 3.3, SD 2.0 vs 1.8, SD 1.6 for QuitGuide; P<.001). Pivot participants had increased self-efficacy via the Smoking Abstinence Self-Efficacy Questionnaire (mean point increase 3.2, SD 7.8, P<.001 vs 1.0, SD 8.5, P=.26 for QuitGuide). QuitGuide participants made more mean quit attempts (7.0, SD 6.3 for Pivot vs 9.5, SD 7.5 for QuitGuide; P=.01). Among those who did not achieve abstinence, QuitGuide participants reported greater CPD reduction (mean -34.6%, SD 35.5% for Pivot vs -46.1%, SD 32.3% for QuitGuide; P=.04). Among those who reported abstinence, 90% (35/39) of Pivot participants and 90% (26/29) of QuitGuide participants indicated that their cessation program helped them quit.ConclusionsThis pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks.Trial registrationClinicalTrials.gov NCT04955639; https://clinicaltrials.gov/ct2/show/NCT04955639.

Dataset Information

Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol.

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Randomized controlled trial of mailed Nicotine Replacement Therapy to Canadian smokers: study protocol.

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