Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01314378
Other study ID # IBTP
Secondary ID 1R03DA0308992009
Status Active, not recruiting
Phase N/A
First received February 24, 2011
Last updated May 1, 2012
Start date January 2011
Est. completion date October 2012

Study information

Verified date May 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date October 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Mindfulness Training
Eight session intensive behavioral training program for smokers
Cognitive-Behavioral Therapy
Eight session intensive behavioral intervention for smokers

Locations

Country Name City State
United States MGH Center for Addiction Medicine Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Massachusetts General Hospital Harvard University, Mind and Life Institute, Hadley, Massachusetts, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expired air carbon monoxide as measure of smoking status Primary Clinical Outcome Measure study week 16 No
Primary Behavioral impulsivity and response inhibition as measured with Experiential Discounting Task (EDT) and Stop-Signal Task (SST). Primary Outcome Measure for Impulsivity Study week 8 No
Secondary Biochemically verified 7-day point prevalence abstinence. Secondary Clinical Outcome Measure Study week 16 follow-up No
Secondary Minutes of mindfulness practice will correlate with performance change in both EDT and SST. Secondary Outcome Measure for Dose Effect Study week 8 No
See also
  Status Clinical Trial Phase
Recruiting NCT05176418 - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate Early Phase 1
Completed NCT04084210 - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use Phase 2
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Withdrawn NCT03707600 - State and Trait Mediated Response to TMS in Substance Use Disorder N/A
Recruiting NCT03999099 - Targeting Orexin to Treat Nicotine Dependence Phase 1
Completed NCT03847155 - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery N/A
Completed NCT02840435 - Study on Sit to Quit Phone Intervention N/A
Completed NCT02139930 - Project 2: Strategies for Reducing Nicotine Content in Cigarettes N/A
Completed NCT01926626 - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers Phase 2
Completed NCT01982110 - A Mindfulness Based Application for Smoking Cessation N/A
Withdrawn NCT01569477 - Striving to Quit-Wisconsin Tobacco Quit Line N/A
Completed NCT01685996 - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation Phase 1/Phase 2
Completed NCT01569490 - Striving to Quit: First Breath N/A
Completed NCT01632189 - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers N/A
Active, not recruiting NCT01182766 - New Treatment for Alcohol and Nicotine Dependence Phase 2/Phase 3
Completed NCT00996034 - Nicotine Vaccination and Nicotinic Receptor Occupancy Phase 2
Completed NCT01061528 - Coping Skills Treatment for Smoking Cessation N/A
Suspended NCT01636336 - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects N/A
Completed NCT01943994 - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study N/A
Withdrawn NCT01589081 - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect N/A