Tobacco SmokingIBTPNCT01314378
Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers
A study testing Mindfulness Training and Cognitive-Behavioral Therapy in people with Tobacco Smoking and Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking, Nicotine Dependence, Impulsivity
- What is being tested?
- Mindfulness Training and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and men aged 18-65, inclusive, who are competent, wish to participate and willing to provide informed consent.
- Self report smoking >=15 cigarettes/day.
- Expired air CO > 9ppm at the time of enrollment.
Who cannot join
- 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.
- 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.
- Reported history of active substance use disorder other than nicotine or caffeine in the last six months.
- 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.)
- 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.
- History of either cerebrovascular events (i.e., stroke, TIA) or head injuries with lasting neurological sequelae; history of seizure disorder or current CNS tumor.
Show all 9Show fewer
- Use of investigational medication in the past 30 days.
- Third trimester pregnancy.
- Inability to speak, read, or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Center for Addiction Medicine
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Being tested
- Mindfulness Training, Cognitive-Behavioral Therapy
- Keywords
- Mindfulness, Cognitive behavioral therapy, Smoking, Impulsivity, Inhibitory Control
- Medical subject headings
- Tobacco Smoking, Tobacco Use Disorder, Impulsive Behavior, Behavior, Addictive, Substance-Related Disorders, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
Eight session intensive behavioral training program for smokers
Cognitive-Behavioral TherapyBehavioural
Eight session intensive behavioral intervention for smokers
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Active comparator | Not described Receives: Behavioral: Cognitive-Behavioral Therapy |
| Mindfulness Training | Experimental | Not described Receives: Behavioral: Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired air carbon monoxide as measure of smoking status
Primary Clinical Outcome Measure
Measured: study week 16
Behavioral impulsivity and response inhibition as measured with Experiential Discounting Task (EDT) and Stop-Signal Task (SST).
Primary Outcome Measure for Impulsivity
Measured: Study week 8
Secondary outcomes (2)
Biochemically verified 7-day point prevalence abstinence.
Secondary Clinical Outcome Measure
Measured: Study week 16 follow-up
Minutes of mindfulness practice will correlate with performance change in both EDT and SST.
Secondary Outcome Measure for Dose Effect
Measured: Study week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2012
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mind and Life Institute, Hadley, Massachusetts, Harvard University
- Responsible party
- Principal investigator, Zev Schuman-Olivier, Massachusetts General Hospital
- Investigators
- Zev D Schuman-Olivier, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314378
- Sponsor's protocol ID
- IBTP
- Other IDs
- 1R03DA030899, 2009-1-014
- Acronym
- IBTP
- Status last verified
- May 2012
- First submitted
- 24 Feb 2011
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Behavioral Training Program on Impulsivity and Inhibitory Control in Smokers
- ClinicalTrials.gov ID
- NCT01314378
- Acronym / sponsor ID
- IBTP / IBTP
- Keywords
- Mindfulness, Cognitive behavioral therapy, Smoking, Impulsivity, Inhibitory Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Mind and Life Institute, Hadley, Massachusetts, Harvard University
- Study start
- Jan 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-Behavioral Therapy | Active comparator | Behavioral: Cognitive-Behavioral Therapy |
| Mindfulness Training | Experimental | Behavioral: Mindfulness Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women and men aged 18-65, inclusive, who are competent, wish to participate and willing to provide informed consent.
- Self report smoking >=15 cigarettes/day.
- Expired air CO > 9ppm at the time of enrollment.
Key exclusion criteria (9 listed)
- 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.
- 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.
- Reported history of active substance use disorder other than nicotine or caffeine in the last six months.
- 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.)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TrainingEight session intensive behavioral training program for smokers | Behavioural | Mindfulness Training |
| Cognitive-Behavioral TherapyEight session intensive behavioral intervention for smokers | Behavioural | Cognitive-Behavioral Therapy |
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
2 secondary outcomes
Biochemically verified 7-day point prevalence abstinence.
Time frame: Study week 16 follow-up
Minutes of mindfulness practice will correlate with performance change in both EDT and SST.
Time frame: Study week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
- Clinical Trials at Partners DescriptionLink provided by the sponsor.
Related trials for Tobacco Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zev D Schuman-Olivier, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Cognitive-Behavioral Therapy in people with Tobacco Smoking and Nicotine Dependence, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expired air carbon monoxide as measure of smoking status (time frame: study week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.