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

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ClinicalTrials.gov Identifier: NCT01362101
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 23, 2011
First Posted Date  ICMJE May 27, 2011
Last Update Posted Date July 11, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
physiologic reactivity (skin conductance, Heart rate, electromyogram, cortisol measures) to smoking cues in recently abstinent tobacco smokers [ Time Frame: It will be measured twice during the study: before treatment (baseline at week 0) and an average of 7 days after treatment (end point assessment) ]
  • Wk 0: development of scripts based on participant's descriptions of the most salient aspects of the smoking experience that triggers craving. Then they will undergo pre-treatment psychophysiological activation to smoking-related cues using the script driven imagery technique (smoking-related and affectively neutral scripts), in vivo cues and salivary cortisol testing.
  • Wk 4: After the last MT or CBT session, participants will undergo post-treatment psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues and salivary cortisol testing.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2011)
self reported of cue-induced negative affect, craving, and stress in recently abstinent tobacco smokers [ Time Frame: It will be measured twice at the baseline assessment (before and after script driven imagery) and twice at the end point assessment (before and after script driven imagery) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
Official Title  ICMJE Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Smokers
Intervention  ICMJE Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)

60 smokers will enter a separate 4 wk group sessions trial that evaluates efficacy of MT in comparison to CBT for smoking cessation. During the parent study, participants will receive bi-weekly sessions of either MT or CBT, for 4 weeks and to set a quit date at the end of the 2nd week. In this context, we will examine participants at two points:

  • Week 0-1 of MT/CBT: development of smoking scripts based participant's descriptions of situations that trigger tobacco craving.
  • Then participants will undergo pre-treatment (week 0-1) and post treatment (week 4) psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues, salivary cortisol testing and to complete a computerized SST protocol.
Study Arms  ICMJE
  • Active Comparator: Traditional behavioral intervention
    Intervention: Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)
  • Active Comparator: Mindfulness behavioral intervention
    Intervention: Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2013)
56
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
60
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362101
Other Study ID Numbers  ICMJE 2010P-001316
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party A. Eden Evins, Massachusetts General Hospital
Study Sponsor  ICMJE A. Eden Evins
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gladys N Pachas, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP