Clinical trial NCT01362101: Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
Official title: Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smokers
Keywords: cue reactivity
physiologic activation
craving
smoking cues
Behavioral therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: physiologic reactivity (skin conductance, Heart rate, electromyogram, cortisol measures) to smoking cues in recently abstinent tobacco smokers
timeFrame: 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)
Secondary outcomes:
measure: self reported of cue-induced negative affect, craving, and stress in recently abstinent tobacco smokers
timeFrame: 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)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center For Addiction Medicine-Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gladys N Pachas, MD
role: PRINCIPAL_INVESTIGATOR
References: