Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: Floating prolonged abstinence

Aveyard, Paul; Wang, Dechao; Connock, Martin; Fry‐Smith, A; Barton, Pelham; Moore, David

doi:10.1093/ntr/ntp035

Cited by 24 publications

(19 citation statements)

References 25 publications

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“…30,31 We also measured whether participants were ever abstinent for 7 days during the study, as short-term durations of abstinence predict eventual cessation. 7 …”

Section: Methodsmentioning

confidence: 99%

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Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit

Carpenter

Hughes²,

Gray³

et al. 2011

Arch Intern Med

116

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Background Rates of smoking cessation have not changed in a decade, accentuating the need for novel approaches to prompt quit attempts. Methods 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. Results 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). Conclusion Nicotine therapy sampling during a PQA represents a novel strategy to motivate smokers to make a quit attempt. Trial Registration clinicaltrials.gov Identifier: NCT00706979

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“…30,31 We also measured whether participants were ever abstinent for 7 days during the study, as short-term durations of abstinence predict eventual cessation. 7 …”

Section: Methodsmentioning

confidence: 99%

“…Cessation induction studies 2,7,8 differ from traditional cessation trials in at least the following 2 ways: (1) the target population is smokers without current intention to quit (smokers unmotivated to quit) and (2) the studies primarily focus on prompting quit attempts (abstinence is the eventual goal but is secondary).…”

mentioning

confidence: 99%

Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit

Carpenter

Hughes²,

Gray³

et al. 2011

Arch Intern Med

116

View full text Add to dashboard Cite

show abstract

“…Work-groups from the Society for Research on Nicotine and Tobacco and others [22–24] have published relevant recommendations on measuring craving and withdrawal [25], self-report criteria for abstinence in clinical trials [26] and biochemical verification of abstinence [27]. …”

Section: Perspectives On Primary Outcomes From Trials With Legal Drugmentioning

confidence: 99%

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end‐points in clinical trials

et al. 2011

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Aims Clinical trials test the safety and efficacy of behavioral and pharmacological interventions in drug-dependent individuals. However, there is no consensus about the most appropriate outcome(s) to consider in determining treatment efficacy or on the most appropriate methods for assessing selected outcome(s). We summarize the discussion and recommendations of treatment and research experts, convened by the US National Institute on Drug Abuse, to select appropriate primary outcomes for drug dependence treatment clinical trials, and in particular the feasibility of selecting a common outcome to be included in all or most trials. Methods A brief history of outcomes employed in prior drug dependence treatment research, incorporating perspectives from tobacco and alcohol research, is included. The relative merits and limitations of focusing on drug-taking behavior, as measured by self-report and qualitative or quantitative biological markers, are evaluated. Results Drug-taking behavior, measured ideally by a combination of self-report and biological indicators, is seen as the most appropriate proximal primary outcome in drug dependence treatment clinical trials. Conclusions We conclude that the most appropriate outcome will vary as a function of salient variables inherent in the clinical trial, such as the type of intervention, its target, treatment goals (e.g. abstinence or reduction of use) and the perspective being taken (e.g. researcher, clinical program, patient, society). It is recommended that a decision process, based on such trial variables, be developed to guide the selection of primary and secondary outcomes as well as the methods to assess them.

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“…Given this, interventions that promote the occurrence of a quit attempt (i.e., cessation induction) are just as important as interventions that promote abstinence once a quit attempt is made (i.e., cessation efficacy), and may have a larger impact on smoking prevalence at the population level. Despite this, few smoking cessation treatments focus exclusively on cessation induction as the primary goal (Aveyard et al, 2009; Carpenter, Hughes, Solomon, & Callas, 2004; Jardin et al, 2014). …”

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confidence: 99%

A mechanistic test of nicotine replacement therapy sampling for smoking cessation induction.

Burris

Heckman

Mathew³

et al. 2015

Psychology of Addictive Behaviors

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Studies that explore the mechanisms of treatment effect are needed in the area of smoking cessation induction, the primary goal of which is to promote the occurrence of a quit attempt among individuals who report little interest in smoking cessation. This study tested the mediational effect of five psychological variables (motivation to quit, abstinence self-efficacy, knowledge of nicotine replacement therapy (NRT), and both positive and negative attitudes toward NRT) on the relationship between NRT sampling and smoking outcomes. Adults who reported low levels of intention to quit in the next month (n=593) were recruited for a nationwide randomized clinical trial of NRT sampling. Participants provided self-report data via telephone interview on multiple occasions, with the final follow-up at six months. Motivation to quit, and to a lesser degree, abstinence self-efficacy at the end of the six-week intervention best accounted for the effect of NRT sampling as a promoter of quit attempts, smoking reduction, and 7-day point prevalence abstinence. Providing smokers with free NRT samples, in addition to encouraging them to engage in temporary abstinence, results in meaningful change in motivation and self-efficacy, which in turn influence smoking outcomes. Cessation induction interventions should aim to increase motivation to quit and abstinence self-efficacy, above and beyond any efforts to increase knowledge or prompt attitudinal shifts.

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Assessing the outcomes of prolonged cessation-induction and aid-to-cessation trials: Floating prolonged abstinence

Cited by 24 publications

References 25 publications

Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit

Nicotine Therapy Sampling to Induce Quit Attempts Among Smokers Unmotivated to Quit

Primary outcome indices in illicit drug dependence treatment research: systematic approach to selection and measurement of drug use end‐points in clinical trials

A mechanistic test of nicotine replacement therapy sampling for smoking cessation induction.

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