Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers (IBTP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01314378
Recruitment Status : Unknown
Verified May 2012 by Zev Schuman-Olivier, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 14, 2011
Last Update Posted : May 2, 2012
National Institute on Drug Abuse (NIDA)
Mind and Life Institute, Hadley, Massachusetts
Harvard University
Information provided by (Responsible Party):
Zev Schuman-Olivier, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Nicotine Dependence Impulsivity Addiction Substance Dependence Behavioral: Mindfulness Training Behavioral: Cognitive-Behavioral Therapy Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : October 2012

Arm Intervention/treatment
Active Comparator: Cognitive-Behavioral Therapy Behavioral: Cognitive-Behavioral Therapy
Eight session intensive behavioral intervention for smokers
Experimental: Mindfulness Training Behavioral: Mindfulness Training
Eight session intensive behavioral training program for smokers

Primary Outcome Measures :
  1. Expired air carbon monoxide as measure of smoking status [ Time Frame: study week 16 ]
    Primary Clinical Outcome Measure

  2. 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

Secondary Outcome Measures :
  1. Biochemically verified 7-day point prevalence abstinence. [ Time Frame: Study week 16 follow-up ]
    Secondary Clinical Outcome Measure

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Women and men aged 18-65, inclusive, who are competent, wish to participate and willing to provide informed consent.
  2. Self report smoking >=15 cigarettes/day.
  3. Expired air CO > 9ppm at the time of enrollment.

Exclusion Criteria:

  1. DSM-IV diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, lifetime history of psychotic disorder, bipolar disorder, severe PTSD, Dissociative Identity Disorder, OCD, anorexia nervosa, mental retardation, or autism. History of moderate or severe major depressive episode or generalized anxiety disorder within the last 6 months. Currently symptomatic ADHD with either current stimulant treatment or a history of stimulant treatment for greater than 1 year.
  2. Use of prescribed psychotropic medication other than SSRI/NDRI/SNRI/buprenorphine in past 6mo, or change in such psychiatric medication dose in past six months.
  3. Reported history of active substance use disorder other than nicotine or caffeine in the last six months.
  4. Positive urine toxicology for illicit drugs, alcohol, opiates or benzodiazepines. (This does not include buprenorphine if participant can demonstrate 6 months of addiction treatment with negative urine screens. With the consent of the participant, participation will be discussed with the potential subject's addiction treatment provider prior to initiation of interventions.)
  5. Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 4 months. History of life-threatening arrhythmia, CHF, syncope, or myocardial infarction within the last year. Abnormal cardiovascular event, or uncontrolled hypertension within last 2 months.
  6. History of either cerebrovascular events (i.e., stroke, TIA) or head injuries with lasting neurological sequelae; history of seizure disorder or current CNS tumor.
  7. Use of investigational medication in the past 30 days.
  8. Third trimester pregnancy.
  9. Inability to speak, read, or understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01314378

United States, Massachusetts
MGH Center for Addiction Medicine
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Drug Abuse (NIDA)
Mind and Life Institute, Hadley, Massachusetts
Harvard University
Principal Investigator: Zev D Schuman-Olivier, MD Massachusetts General Hospital

Additional Information:
Responsible Party: Zev Schuman-Olivier, Research Fellow, Massachusetts General Hospital Identifier: NCT01314378     History of Changes
Other Study ID Numbers: IBTP
1R03DA030899 ( U.S. NIH Grant/Contract )
2009-1-014 ( Other Grant/Funding Number: Mind and Life Institute )
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Keywords provided by Zev Schuman-Olivier, Massachusetts General Hospital:
Cognitive behavioral therapy
Inhibitory Control

Additional relevant MeSH terms:
Tobacco Use Disorder
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders