Nicotine Dependence Clinical Trial
Official title:
Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers
Dependence on tobacco derived nicotine is a major public health problem. Substance users who complete training in mindfulness subjectively report increased patience and improved motor control over their impulses. Yet, no studies have tested this perceived benefit with behavioral measures of impulse control. The investigators are conducting a randomized controlled clinical trial, which compares Cognitive-Behavioral Therapy and Mindfulness Training for tobacco smokers, using behavioral measures to investigate the effects of mindfulness training on impulsivity and inhibitory control.
Dependence on tobacco derived nicotine is a major public health problem. Data suggest
tobacco smokers are more impulsive on both self-report and behavioral measures than
non-smokers. Behavioral measures of impulsivity predict outcome during smoking cessation.
Successful quitters have better impulse control compared to current smokers. Impulsivity is
defined behaviorally as a predisposition toward rapid, unplanned reactions to internal and
external stimuli without regard for the negative consequences. Impulsivity is often measured
behaviorally in two major domains, delay discounting, i.e., the choice of smaller immediate
reward over a larger, delayed reward, and response inhibition, the inability to stop a
response once it is initiated. A drug-free method that decreases smokers' impulsivity and
enhances inhibitory control could improve sustained efficacy of smoking cessation treatment.
Treatments integrating mindfulness have been associated with decreases in impulsiveness and
substance use in people with addiction. A preliminary study of reports that 100% of
mindfulness-trained smokers that meditated at least 45 minutes daily were still abstinent at
6 weeks post-quit. Preliminary data suggest that mindfulness training benefits people with
substance use disorders through multiple cognitive mechanisms, including decreased
self-report motor impulsiveness. Yet, no widely accepted behavioral measures of impulsivity
or inhibitory control have been used to measure the effect of mindfulness practice in
smokers. This project aims to evaluate the relationship between mindfulness and behavioral
measures of impulsivity and inhibitory control in smoking cessation and early abstinence.
Data from mindfulness-oriented treatment studies suggest at-home formal meditation practice
is the most important variable in attaining positive clinical outcomes. This conclusion
supports the prevailing theory that high doses of repetitive meditation practice can elicit
cortical remodeling. Since addiction has been conceptualized as a disease of staged
neuroplasticity, an intensive behavioral program that can induce accelerated therapeutic
neuroplasticity is particularly compelling. Current methods for self-reporting dose of
formal mindfulness practice may be vulnerable to response bias and poor reporting response
rates. We plan to use actigraphic monitoring of formal mindfulness practice using the
Actiwatch Score to behaviorally validate meditation time and rigorously test the meditation
dose effect theory which hypothesizes that formal meditation practice time will predict
improvement in inhibitory control, delay discounting, and smoking outcomes.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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