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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01362101
• Date of registration: 23/05/2011
• Primary sponsor: Massachusetts General Hospital
• Public title: Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol physio
• Scientific title: Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
• Date of first enrolment: July 2010
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01362101
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Countries of recruitment

United States

Contacts

• Name: Gladys N Pachas, MD

• Name: Gladys N Pachas, MD

• Name: Gladys N Pachas, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Smokers

Intervention(s)

Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)

Primary Outcome(s)

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)]

Secondary Outcome(s)

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)]

Secondary ID(s)

2010P-001316

Source(s) of Monetary Support

Please refer to primary and secondary sponsors