Nicotine Dependence Clinical Trial
Official title:
A Mindfulness Based Application for Smoking Cessation
Cigarette smoking is the leading cause of preventable death and disability in the world. Although over 70% of smokers want to quit, fewer than 5% achieve this goal annually. Additional effective, safe, and accessible treatments for nicotine dependence are needed due to the low abstinence rates (20-30%) achieved in behavioral therapies, the unappealing side effects of pharmacotherapy, and the frequent lack of accessibility to treatment. Recent evidence supports the central role of craving in maintaining nicotine dependence, and neither behavioral nor replacement therapies directly target the relationship between cravings and smoking. Mindfulness therapy has been found to be effective in teaching strategies to decouple the association between craving and smoking. Mindfulness based smoking therapy (MT) has preliminary support for reducing consumption in smokers, and Dr. Judson Brewer has recently translated this program into a mobile device application (app) for smoking cessation. With Dr. Brewer's consultation, we propose to assess the feasibility of implementation of a MT mobile application in local hospital and community clinics and the effectiveness of the MT mobile application compared to a National Cancer Institute (NCI) QuitPal behavioral change group. We will examine smoking results at end of treatment and 2 and 6 month follow-up as well as the role of craving. If MT smoking cessation is determined to be effective in a mobile phone application, this finding will be a significant step in providing an additional effective and safe treatment for smokers wishing to quit or cut down on their intake, and will be especially important in providing treatment options for marginalized or hard-to-access individuals wishing to reduce cigarette intake.
Cigarette smoking is the leading cause of preventable death and disability in the world,
accounting for 10% of all deaths. In the US, smoking costs more than $193 billion in health
care costs and lost productivity per year. Although over 70% of smokers want to quit, fewer
than 5% achieve this goal annually. Mainstay behavioral treatments for smoking have focused
on teaching individuals to avoid cues, foster positive affective states, develop lifestyle
changes that reduce stress, divert attention from cravings, substitute other activities for
smoking, learn cognitive strategies that reduce negative mood and develop social support
mechanisms. These have shown modest success, with abstinence rates between only 20-30% over
the past thirty years. This is presumably due to the complex nature of the acquisition and
maintenance of nicotine addiction, including associative learning mechanisms as well as
positive and negative reinforcement. Over time, cues that are judged to be positive or
negative can induce affective states, which can then trigger a craving to smoke. Though the
centrality of craving remains controversial, evidence suggests that craving is strongly
associated with smoking, which, mainly through the physiological properties of nicotine,
results in the maintenance or improvement of positive or reduction of negative affective
states. This sets up reinforcement loops by reinforcing memories between affect and smoking.
Thus, attention has been focused on additional strategies to help people tolerate negative
affect and cravings rather than avoiding cues or substituting activities, and recent research
suggest that MT may decouple the association between craving and smoking, thus facilitating
smoking cessation.
Mindfulness training (MT) targets affective or craving states by teaching individuals to
observe aversive body and mind states instead of reacting to them with habitual reactions,
thus allowing more adaptive, healthier responses. Mindfulness training (MT) has shown promise
in reducing anxiety and depression and has recently been explored in the treatment of
addictions. In a 2011 randomized controlled trial by Brewer, et al., individuals who received
an 8- session MT vs. the American Lung Association's 8 session freedom from smoking (FFS)
treatment, showed significantly greater rate of reduction in cigarette use and greater point
prevalence abstinence rates during treatment and maintained these gains during follow up. FFS
is a behavior modification program and includes stress reduction and relapse prevention.
Although both treatment groups were assigned home practice as part of their treatment, only
those who received mindfulness training demonstrated a significant association between home
practice and smoking outcomes, suggesting that there was a specific benefit to mindfulness
practice and that positive treatment outcomes for those in this group are not merely a result
of greater enthusiasm or interest in quitting. The ability of MT to attenuate the
relationship between craving and substance use has been observed in other studies as well.
Elwafi, et al. (2012) demonstrated that people who practiced mindfulness more smoked less,
regardless of their level of craving. Practicing mindfulness appears critical to MT treatment
outcomes. These results suggest that MT may help individuals develop a tolerance to craving
itself, thus over time acting to dismantle the addictive loop. To date, research in this area
has been conducted in randomized clinical trials in structured laboratory settings only.
Important next steps are to examine the effectiveness of MT treatments for smoking cessation
in naturalistic environments and to utilize methods of delivering treatment in real world
settings that will facilitate compliance with mindfulness practice and thus improve treatment
outcomes - for example, via a mobile device application. Additionally, trials comparing MT to
alternative treatment approaches typically offered in outpatient clinics such as support
groups, acupuncture, individual counseling, or nicotine replacement therapies are lacking.
Mindfulness based (MT) smoking cessation has been adapted to a mobile device application
called "Craving to Quit" based on the work done by Brewer and will be the mindfulness
intervention used in this study. Standardization and implementation via a mobile application
is a logical and necessary next step in the dissemination of treatment and will potentially
provide access to an effective smoking cessation program for persons who may not otherwise be
able to access treatment.
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