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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Mind and Life Institute, Hadley, Massachusetts
Harvard University
Information provided by (Responsible Party):
Zev Schuman-Olivier, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01314378
First received: February 24, 2011
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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 Intervention
Tobacco Smoking
Nicotine Dependence
Impulsivity
Addiction
Substance Dependence
Behavioral: Mindfulness Training
Behavioral: Cognitive-Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Expired air carbon monoxide as measure of smoking status [ Time Frame: study week 16 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Primary Outcome Measure for Impulsivity


Secondary Outcome Measures:
  • Biochemically verified 7-day point prevalence abstinence. [ Time Frame: Study week 16 follow-up ] [ Designated as safety issue: No ]
    Secondary Clinical Outcome Measure

  • Minutes of mindfulness practice will correlate with performance change in both EDT and SST. [ Time Frame: Study week 8 ] [ Designated as safety issue: No ]
    Secondary Outcome Measure for Dose Effect


Estimated Enrollment: 72
Study Start Date: January 2011
Estimated Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01314378

Locations
United States, Massachusetts
MGH Center for Addiction Medicine
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Mind and Life Institute, Hadley, Massachusetts
Harvard University
Investigators
Principal Investigator: Zev D Schuman-Olivier, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Zev Schuman-Olivier, Research Fellow, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01314378     History of Changes
Other Study ID Numbers: IBTP, 1R03DA030899, 2009-1-014
Study First Received: February 24, 2011
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Mindfulness
Cognitive behavioral therapy
Smoking
Impulsivity
Inhibitory Control

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

ClinicalTrials.gov processed this record on September 30, 2014