Clinicians are often frustrated by patients who are resistant to health behavior change. Motivating the unmotivated can be a significant challenge, whether the problem behavior is, for example, tobacco or alcohol use, diet, exercise, or screening. Often, a clinician will rely on persuasive messaging, but in the absence of any demonstrable change, that clinician will have few other options at his or her disposal. Cigarette smoking represents a particularly entrenched behavior. Despite vast improvements in tobacco control, most smokers remain either unable or unwilling to quit. Less than 10% of smokers report wanting to quit in the immediate future [1
], and 60% of all smokers do not make a quit attempt during any given year [2
]. For these change-resistant smokers, novel strategies are necessary for cessation induction
, that is, inducing motivation to quit and quit attempts among smokers who otherwise lack both.
Cessation induction trials are common in the smoking literature. Physician-delivered brief advice is an effective approach that reaches many smokers, but meta-analytic reviews suggest only modest effect sizes [3
]. Another common approach is through interventions tied to stages of change [5
]; that is, the idea that smokers at different stages of readiness to quit (precontemplation, contemplation, preparation, action) require different interventions. Across a number of studies, stage-based interventions have been shown to be efficacious [6
], although two comprehensive reviews questioned the strength of data for stage-based interventions [9
We believe one viable approach to prompt quitting behavior is the notion of sampling cessation medications as a means to learn more about the process of quitting. Despite strong evidence in support of nicotine replacement therapy (NRT) [4
], many smokers have enduring misperceptions and strong misgivings about these pharmacotherapies [11
]. Even as an over-the-counter product, under-use of NRT persists [16
]. Several studies have shown that provision of NRT samples to smokers often enhances cessation behaviors [18
], though these were uncontrolled studies and it is not yet entirely clear if sampling per se
had any direct effect. Free patch give-away incentives to smokers engaged in a telephone quitline, who presumably may be more motivated to quit, typically yield large increases in call volume and ultimately enhance quit rates [21
]. Whether a similar NRT sample for unmotivated smokers would have the same effect is unclear, but there is ample rationale for the notion that sampling NRT might motivate smokers towards quitting. Primarily, sampling NRT may increase self-efficacy and familiarization among smokers, particularly those who feel they cannot quit or who have never used NRT previously. A recent test of very brief sampling (i.e., one time use) of NRT demonstrated a positive shift in attitudes towards subsequent use [24
], but did not test for subsequent effects on cessation behaviors. Thus, for smokers who are resistant to quitting, sampling NRT for short periods of time could serve as a catalyst for making a quit attempt.
To provide structure for the experience of sampling NRT, we and others [25
] propose the notion of short periods of ‘trial quitting,’ which itself could serve as a motivating and learning experience to prompt further attempts to quit [25
]. The notion of a practice quit attempt is conceptually similar to the CBT practice of ‘behavioral experiments’ [27
] and is partly based on concepts derived from the Great American Smokeout, sponsored by the American Cancer Society. The Great American Smokeout was originally designed for ambivalent smokers to take a brief pause of smoking, if only for a day, to learn about the process of quitting and enhance further resolve. Empirical tests of the Smokeout are lacking, but the presumption is that short periods of abstinence may lead to sustained quitting. Partial evidence for this presumption comes from a small test, which experimentally manipulated brief periods of abstinence among smokers who did not want to quit [29
]. Results from that study showed that brief episodes of nonsmoking enhance future abstinence.
Most previous studies have not focused on unmotivated smokers. In this article, we describe the design and methods of a large, ongoing nationwide telephone-based clinical trial to prompt quit attempts among unmotivated smokers (NCT00706979), in which we specifically test whether adding free NRT to brief advice to undertake a practice quit attempt will motivate more smokers to make a serious attempt to stop smoking than brief advice without NRT. A primary focus on cessation would be ideal. Given the study focus on smokers who are unmotivated to quit, the present study was premised on the fact that quit attempts are a necessary precursor to cessation. Thus, it is imperative to first demonstrate that the intervention can induce quit attempts before expending the resources for the much larger study that would be needed to determine the efficacy of the intervention for smoking cessation. Throughout, we describe the sampling method, interventions, and measures of outcome that are perhaps unique to a study of unmotivated smokers. 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.