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Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial.

ABSTRACT: Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts.Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week intervention period, participants were followed up for 6 months to assess outcomes. The PQA intervention was designed to increase motivation, confidence, and coping skills. The combination of a PQA plus nicotine therapy sampling added samples of nicotine lozenges to enhance attitudes toward pharmacotherapy and to promote the use of additional cessation resources. Primary outcomes included the incidence of any ever occurring self-defined quit attempt and 24-hour quit attempt. Secondary measures included 7-day point prevalence abstinence at any time during the study (ie, floating abstinence) and at the final follow-up assessment.Compared with PQA intervention, nicotine therapy sampling was associated with a significantly higher incidence of any quit attempt (49% vs 40%; relative risk [RR], 1.2; 95% CI, 1.1-1.4) and any 24-hour quit attempt (43% vs 34%; 1.3; 1.1-1.5). Nicotine therapy sampling was marginally more likely to promote floating abstinence (19% vs 15%; RR, 1.3; 95% CI, 1.0-1.7); 6-month point prevalence abstinence rates were no different between groups (16% vs 14%; 1.2; 0.9-1.6).Nicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt.clinicaltrials.gov Identifier: NCT00706979.

SUBMITTER: Carpenter MJ

PROVIDER: S-EPMC3372898 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial.

Carpenter Matthew J MJ Hughes John R JR Gray Kevin M KM Wahlquist Amy E AE Saladin Michael E ME Alberg Anthony J AJ

Archives of internal medicine 20111101 21

<h4>Background</h4>Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts.<h4>Methods</h4>Within a nationwide randomized clinical trial (N = 849) to induce further quit attempts and cessation, smokers currently unmotivated to quit were randomized to a practice quit attempt (PQA) alone or to nicotine replacement therapy (hereafter referred to as nicotine therapy), sampling within the context of a PQA. Following a 6-week interven ...[more]

PMID: 22123796

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Project description:BackgroundAlthough the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition.Methods/designA sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing's effect on cessation.DiscussionThis trial will provide the most rigorous evaluation to date of Motivational Interviewing's efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI's impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline.Trial registrationClinicalTrials.gov NCT01188018.

Project description:IntroductionCigarette smoking disproportionately affects communities of low socioeconomic status where greater smoking prevalence and poorer cessation rates have been observed. Utilizing brief evidence-based interventions to increase cessation attempts may be an effective and easily disseminable means by which to mitigate undue burden in this population.Aims and methodsThe current intervention randomized daily smokers (N = 57) recruited from a local community soup kitchen to receive either Brief (eg, 30 m) Motivational Interviewing, Nicotine Replacement Therapy (NRT) sampling, or a Referral-Only intervention. Approximately half of participants (50.9%) reported not completing high school and many reported either just (41.4%) or not (40.4%) meeting basic expenses. Follow-up was completed approximately 1-month postintervention.ResultsNonsignificant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size). Approximately 40% of the sample reported making a serious quit attempt at follow-up. Significant differences in cigarettes per day at follow-up, controlling for baseline, were observed, with participants in the Motivational Interviewing condition, only, reporting significant reductions. Participants randomized to the NRT condition were significantly more likely to report using NRT patch and lozenge at follow-up (large effect). There were no differences between groups with respect to seeking behavioral support. Finally, we found that subjective financial strain moderated the effect of condition on change in cigarette consumption where NRT sampling was more effective for participants reporting less financial strain.ConclusionsFindings provide initial evidence for personalizing brief interventions to promote quit attempts in low-income smokers.ImplicationsWhile most clinical research on tobacco use and dependence focuses on successful sustained abstinence, the current study is novel because it examined three brief interventions designed to increase the number of quit attempts made by a nontreatment-seeking group suffering from health disparities (ie, smokers from socioeconomic disadvantage). These data suggest that nontreatment-seeking smokers from socioeconomic disadvantage can be influenced by Brief MIs and these interventions should be used to motivate smokers from socioeconomic disadvantage to make a quit attempt. Future studies should examine combined MIs including pharmacological and behavioral interventions.

Project description:AimsLittle is known about the extent to which quit attempts are planned ahead or initiated immediately following a sudden decision to quit. This is important because if most smokers quit abruptly, rather than plan ahead, this could impact heavily upon recommendations to health care professionals on the kind of smoking cessation advice they deliver to patients. This paper aims to address this gap in knowledge by examining detailed smoking histories taken from smoking and ex-smoking patients.DesignFace-to-face in depth semi-structured interviews.Participants146 smoking and ex-smoking patients within a family medicine practice were recruited by means of screening 700 consecutive patients (14 years of age and older) and inviting eligible patients to participate. To be eligible, patients had to have smoked a minimum of five cigarettes per day for at least six months in their lives and made at least one serious quit attempt that lasted at least 24 hours. There were no refusals. Ex-smokers (n = 67) were defined as those who had not smoked for six months. The remainder were classified as smokers (n = 79).MeasurementsParticipants were asked to describe, in their own words, their most recent quit attempt and whether they had planned the quit attempt in advance, what were the triggers, and how long they abstained. A quit attempt was defined as planned if smokers set a quit date at some future time point. An unplanned quit attempt was defined as a sudden decision not to smoke any more cigarettes including those that might be remaining in the current pack. Information was also collected on methods used to quit and reasons for quitting.ResultsA majority (51.6%) of quit attempts were reported as being unplanned. The figure was higher for ex-smokers than for smokers (67.1% v 36.7%, p < 0.001). Most quit attempts were unaided (64%) and made for reasons of health (64%).ConclusionsThe finding that so many quit attempts are unprepared suggests that models of smoking cessation should place greater emphasis on the dynamic nature of motivation to quit. This is an area that requires further investigation.

Project description:IntroductionThis study used data from a randomized controlled trial evaluating the efficacy of motivational interviewing (MI) relative to health education (HE) and brief advice (BA) to encourage quit attempts and cessation in order to determine their relative cost-effectiveness.Aims and methodsUrban community residents (n = 255) with low desire to quit smoking were randomized to MI, HE, or BA which differed in communication style and/or number of treatment sessions. Incremental cost-effectiveness ratios were used to compare the intensive interventions (MI and HE) to BA for facilitating quit attempts and smoking cessation. Costs were calculated from the perspective of an agency that might engage in program delivery. Sensitivity analysis examined different assumptions for MI training and pharmacotherapy costs.ResultsTotal intervention delivery time costs per participant for MI, HE, and BA were $46.63, $42.87, and $2.4, respectively. Cost-effectiveness ratios per quit attempt at 24 weeks were $380 for MI, $272 for HE, and $209 for BA. The cost per additional quit attempt for MI and HE relative to BA was $508 and $301, respectively. The cost per additional quit for MI and HE relative to BA was $2030 and $752, respectively. Four separate sensitivity analyses conducted in our study did not change the conclusion the HE had a lower Incremental Cost-Effectiveness Ratio for both quit attempts and cessation.ConclusionsHE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable for smokers who are less motivated to quit. Providing valuable cost information in choosing different clinical methods for motivating smokers to quit.ImplicationsAll direct costs and activity-based time costs associated with delivering the intervention were analyzed from the perspective of an agency that may wish to replicate these strategies. A randomized controlled trial evaluating the efficacy of MI relative to HE and BA to encourage quit attempts and cessation determined their relative cost-effectiveness. HE was the most cost-effective of the three types of smoking cessation induction therapies and therefore may be preferable. Despite guideline recommendations, MI may not be the best approach to encourage quit attempts in diverse populations. Rather, a structured, intensive HE intervention might be the most cost-effective alternative.

Project description:IntroductionOnline motivational films to promote quit attempts could encourage large numbers of smokers to stop at low unit cost. We evaluated an online film documenting the experiences of smokers who recorded the first month of their successful attempts to quit (4Weeks2Freedom). The film was designed to boost motivation and self-efficacy and provide role-models to promote ex-smoker identities.MethodsThis was a randomized trial with individual assignment to a no-intervention control (n = 1016), an informational film (n = 1004), or 4Weeks2Freedom (n = 999). The development of 4Weeks2Freedom was informed by PRIME theory and focus-group testing with smokers. The 90-minute film was available online to view in one sitting or as chapters over 4 weeks to coincide with the progress of an attempt. The primary outcome was a quit attempt in the 4 weeks between assignment and study endpoint by intent-to-treat.ResultsParticipants smoked a mean of 13 cigarettes per day and 31% reported not wanting to stop. At follow-up, 55% reported viewing the informational control film and 56% viewing 4Weeks2Freedom. There was no detectable effect compared with the no-intervention control (OR = 0.99, 95% CI = 0.81 to 1.21, 24.3% vs. 24.5%) or informational control film (OR = 0.99, 95% CI = 0.80 to 1.21, 24.3% vs. 24.6%). Calculation of Bayes factors ruled out insensitive data and indicated the intervention was no more effective than either the no-intervention control (Bayes factor = 0.20) or informational control film (Bayes factor = 0.27). The pattern of results was unchanged in sensitivity analyses that examined the effect among only those who viewed the films.ConclusionThe online documentary film (4Weeks2Freedom) designed to boost motivation and self-efficacy and to promote ex-smoker identity does not appear to prompt quit attempts among smokers.ImplicationsThis trial found that an online documentary film (4Weeks2Freedom) designed to boost motivation and self-efficacy and to promote ex-smoker identity was ineffective in prompting quit attempts among an unselected panel of smokers from the UK. This approach appears unpromising as a means of raising the rate at which smokers attempt to quit and is a low priority for future research.

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:Individual-level interventions for smokers unmotivated to quit remain scarce and have had limited success. Little is known about the potential of virtual reality (VR) for delivering messaging to smokers unmotivated to quit. This pilot trial aimed to assess the feasibility of recruitment and acceptability of a brief, theory-informed VR scenario and estimate proximal quitting outcomes. Unmotivated smokers (recruited between February-August 2021) aged 18+ years who had access to, or were willing to receive via post, a VR headset were randomly assigned (1:1) using block randomisation to view the intervention (i.e., a hospital-based scenario with motivational stop smoking messaging) or a 'sham' VR scenario (i.e., a scenario about the human body without any smoking-specific messaging) with a researcher present via teleconferencing software. The primary outcome was feasibility of recruitment (i.e., achieving the target sample size of 60 participants within 3 months of recruitment). Secondary outcomes included acceptability (i.e., positive affective and cognitive attitudes), quitting self-efficacy and intention to stop smoking (i.e., clicking on a weblink with additional stop smoking information). We report point estimates and 95% confidence intervals (CIs). The study protocol was pre-registered (osf.io/95tus). A total of 60 participants were randomised within 6 months (intervention: n = 30; control: n = 30), 37 of whom were recruited within a 2-month period of active recruitment following an amendment to gift inexpensive (£7) cardboard VR headsets via post. The mean (SD) age of participants was 34.4 (12.1) years, with 46.7% identifying as female. The mean (SD) cigarettes smoked per day was 9.8 (7.2). The intervention (86.7%, 95% CI = 69.3%-96.2%) and control (93.3%, 95% CI = 77.9%-99.2%) scenarios were rated as acceptable. Quitting self-efficacy and intention to stop smoking in the intervention (13.3%, 95% CI = 3.7%-30.7%; 3.3%, 95% CI = 0.1%-17.2%) and control (26.7%, 95% CI = 12.3%-45.9%; 0%, 95% CI = 0%-11.6%) arm were comparable. The target sample size was not achieved within the feasibility window; however, an amendment to gift inexpensive headsets via post appeared feasible. The brief VR scenario appeared acceptable to smokers unmotivated to quit.

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Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial.

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Nicotine therapy sampling to induce quit attempts among smokers unmotivated to quit: a randomized clinical trial.

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