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View Clinical Trial (Medical Research Study)


Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol

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City:   Boston
State:   Massachusetts
Zip Code:   02478
Conditions:   Healthy Smokers
Purpose:   This study is ancillary. Participants will be recruited as part of a separate clinical trial on effects of two intensive behavioral training programs that evaluates feasibility and efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to compare the effect of MT to that of traditional CBT on a physiological marker of stress, salivary cortisol concentration, and physiological responses to smoking cues in tobacco smokers. The investigators will use electrophysiological reactivity to smoking cues in the form of audio recordings of personalized scripts describing the scenarios associated with the strongest urges to smoke that will provide a physiological validation to a behavioral intervention. The investigators will also explore correlations between these biological markers and self report of stress, craving and negative affect to supplement self report and behavioral outcome measures with biological and physiological markers to represent improvement attributed to the intervention.
Study Summary:  
Criteria:   Inclusion Criteria: 1. Inclusion Criteria for the entire trial: - 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. - Must be willing to participate in a meditation training group. 2. Inclusion criteria for the physiological assessment: - Abstinent for at least 12 hrs prior to the assessment. - CO<15ppm - Have negative urine toxicology for illicit drugs or alcohol. Exclusion Criteria: - 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. - 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. - History of active substance use disorder other than nicotine or caffeine in the last 6 months. - Positive urine toxicology for illicit drugs, alcohol, opiates or benzodiazepines. - 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 cerebro-vascular events (i.e., stroke, TIA), multiple head injuries with neurological sequelae, a single severe head injury with lasting neurological sequelae, history of seizure disorder or current CNS tumor. - Use of investigational medication in the past 30 days. - Inability to speak, read, or understand English.
NCT ID:   NCT01362101
Primary Contact:   Principal Investigator
Gladys N Pachas, MD
Massachusetts General Hospital

Gladys N Pachas, MD
Phone: 617-643-1991
Email: gpachas1@partners.org
Backup Contact:   N/A
Location Contact:   Boston, Massachusetts 02478
United States

Gladys N Pachas, MD
Phone: 617-643-1991
Email: gpachas1@partners.org

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   May 25, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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