Clinical Trial: Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers

Brief Summary: 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.

Detailed Summary:

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
Sponsor: Massachusetts General Hospital

Current Primary Outcome:

• Expired air carbon monoxide as measure of smoking status [ Time Frame: study week 16 ]
  Primary Clinical Outcome Measure
• Behavioral impulsivity and response inhibition as measured with Experiential Discounting Task (EDT) and Stop-Signal Task (SST). [ Time Frame: Study week 8 ]
  Primary Outcome Measure for Impulsivity

Original Primary Outcome:

• Primary Clinical Outcome Measure [ Time Frame: study week 16 ]
  Expired air carbon monoxide as measure of smoking status
• Primary Outcome Measure for Impulsivity [ Time Frame: Study week 8 ]
  Behavioral impulsivity and response inhibition as measured with Experiential Discounting Task (EDT) and Stop-Signal Task (SST).

Current Secondary Outcome:

• Biochemically verified 7-day point prevalence abstinence. [ Time Frame: Study week 16 follow-up ]
  Secondary Clinical Outcome Measure
• Minutes of mindfulness practice will correlate with performance change in both EDT and SST. [ Time Frame: Study week 8 ]
  Secondary Outcome Measure for Dose Effect

Original Secondary Outcome:

• Secondary Clinical Outcome Measure [ Time Frame: Study week 16 follow-up ]
  Biochemically verified 7-day point prevalence abstinence.
• Secondary Outcome Measure for Dose Effect [ Time Frame: Study week 8 ]
  Minutes of mindfulness practice will correlate with performance change in both EDT and SST.

Information By: Massachusetts General Hospital

Dates:
Date Received: February 24, 2011
Date Started: January 2011
Date Completion: October 2012
Last Updated: May 1, 2012
Last Verified: May 2012