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

NCT01314378 | Unknown

• 3 other identifiers: IBTP1R03DA0308992009-1-014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Smoking; Nicotine Dependence; Impulsivity; Addiction; Substance Dependence

Keywords

Mindfulness; Cognitive behavioral therapy; Smoking; Impulsivity; Inhibitory Control

Outcome Measures

Primary Outcomes (2)

• Expired air carbon monoxide as measure of smoking status

  Primary Clinical Outcome Measure

  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

  Study week 8

Secondary Outcomes (2)

• Biochemically verified 7-day point prevalence abstinence.

  Study week 16 follow-up

• Minutes of mindfulness practice will correlate with performance change in both EDT and SST.

  Study week 8

Study Arms (2)

Cognitive-Behavioral Therapy

ACTIVE COMPARATOR

Behavioral: Cognitive-Behavioral Therapy

Mindfulness Training

EXPERIMENTAL

Behavioral: Mindfulness Training

Interventions

Mindfulness Training BEHAVIORAL

Eight session intensive behavioral training program for smokers

Mindfulness Training

Cognitive-Behavioral Therapy BEHAVIORAL

Eight session intensive behavioral intervention for smokers

Cognitive-Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of investigational medication in the past 30 days.
• Third trimester pregnancy.
• Inability to speak, read, or understand English.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Mind and Life Institute, Hadley, Massachusetts: collaborator
• Harvard University: collaborator

Study Sites (1)

MGH Center for Addiction Medicine

Boston, Massachusetts, 02114, United States

Location

Related Links

• Clinical Trials at Partners Description

MeSH Terms

Conditions

Tobacco Smoking; Tobacco Use Disorder; Impulsive Behavior; Behavior, Addictive; Substance-Related Disorders; Smoking

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Zev D Schuman-Olivier, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: February 24, 2011
• First Posted: March 14, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 2, 2012

Record last verified: 2012-05

Locations

US (1)