Motivating the unmotivated for health behavior change: a randomized trial of cessation induction for smokers
Open accessAbstract
Background Many smokers remain unwilling or unable to make a quit attempt. For these smokers, novel strategies to induce quit attempts are necessary to achieve further reductions in smoking prevalence. Purpose This article describes the design and methods of an ongoing nationwide telephone-based clinical trial for cessation induction, the principal aim of which is to test the hypothesis that samples of nicotine replacement therapy (NRT), can induce quit attempts among smokers otherwise unmotivated to quit. Methods Smokers are recruited proactively through online channels. A ‘behavioral filter’ is used to identify and separate motivated versus unmotivated smokers, the latter of whom (N = 750) are formally entered into the clinical trial. Participants are randomized to one of two treatment conditions designed to promote self-efficacy and motivation to quit: (1) practice quit attempt (PQA) or (2) PQA plus NRT sampling. The primary outcome measure tested over a 6-month follow-up is the incidence of additional quit attempts as well as hypothesized mediators of treatment effects. Results This study details the challenges of identifying and treating smokers who are unmotivated to quit. Strengths include a novel treatment approach, tested among a group of proactively recruited smokers nationwide, with a unique method of identifying cessation-resistant smokers. Limitations The omission of a true control group, testing the effect of the PQA itself, is an inherent limitation to the study design. Online recruitment presents additional study challenges, all of which are discussed in detail. Conclusions The study has translational potential to guide both clinical and policy recommendations for cessation induction. Further, while the focus is on smoking, this trial may serve as an example to researchers and clinicians who focus on other health behaviors, and who themselves are challenged with motivating people who are unmotivated for change. Clinical Trials 2010; 7: 157—166. http://ctj.sagepub.com
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A clinical trial of NRTS in primary care clinics found that NRTS increased quit attempts, use of smoking cessation medications, and smoking abstinence at 6 months post-intervention compared to standard care.
“A clinical trial of NRTS in primary care clinics found that NRTS increased quit attempts, use of smoking cessation medications, and smoking abstinence at 6 months post-intervention compared to standard care [13, 16].”
From A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study (2024) · cites this paper as [16]
The Abstract (Purpose) describes an ongoing nationwide telephone-based trial, not a completed trial in primary care clinics. The Methods (Overview of design and study hypotheses) compare practice quit attempts with practice quit attempts plus NRT sampling and hypothesize an increase in quit attempts; the Methods (Outcomes) list medication use and abstinence as measures, not findings. The Discussion (Major methodological questions) explicitly says the study has no no-treatment control group. This paper therefore does not report the claimed six-month improvements over standard care. (LLM, conf=0.89)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredNicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of NRT to people who smoke.
“Nicotine replacement therapy sampling (NRTS) is an empirically supported intervention to provide starter packs of nicotine replacement therapy (NRT) to people who smoke.”
From A National Dental Practice-Based Research Network phase II, cluster-randomized clinical trial assessing nicotine replacement therapy sampling in dental settings: study protocol for the Free Samples for Health (FreSH) study (2024) · cites this paper as [16]
The Methods > Interventions section describes mailing smokers a supply of nicotine lozenges to sample, supporting the description of the intervention. The Introduction reports that earlier studies associated NRT samples with improved cessation behaviors, but says those studies were uncontrolled and that a direct effect of sampling was unclear. This paper describes a trial designed to test that effect, so calling NRT sampling an empirically supported intervention overstates its evidence. (LLM, conf=0.86)
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Nicotine replacement therapy versus control for smoking cessation
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Self-citation
- Authors
- Carpenter, M. J., Alberg, A. J., Gray, K. M., & Saladin, M. E.
- Affiliations
- Medical University of South Carolina (US)
- Corresponding author
- Carpenter, Matthew J
- Venue
- Clinical Trials
- Publisher
- SAGE Publications
- Published
- 2010-03-25
- Volume
- 7
- Issue
- 2
- Pages
- 157-166
- ISSN
- 1740-7745 (ISSN-L)
- 1740-7753
- PMC
- PMC2902976
- OpenAlex
- W2090453844
- Cited by
- 41
- References
- 60
- Citations by year
- 2026: 2 · 2024: 3 · 2023: 1 · 2022: 1 · 2020: 2 · 2019: 3 · 2018: 3 · 2017: 1 · 2016: 3 · 2015: 5 · 2014: 5 · 2013: 6 · 2012: 3
- FWCI
- 2.60
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- GlaxoSmithKline
- National Institute on Drug Abuse (K23DA020482, K12DA000357, R01DA021619)
- National Center for Research Resources (UL1RR029882)
- Topics
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Social Sciences › Psychology › Applied Psychology › Behavioral Health and Interventions
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Keywords
- smoking cessation, nicotine replacement therapy, self-efficacy, motivation to quit, online recruitment, health behavior change, telephone-delivered intervention
- MeSH terms
- Humans, Nicotine, Research Design, Telephone, Health Behavior, Smoking Cessation, Nicotinic Agonists
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