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

NCT ID: NCT01362101

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

Smokers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Traditional behavioral intervention

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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.

Mindfulness behavioral intervention

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

A. Eden Evins

OTHER

Sponsor Role: lead

Responsible Party

A. Eden Evins

Director Center for Addiction Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gladys N Pachas, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Center For Addiction Medicine-Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2010P-001316

Identifier Type: -

Identifier Source: org_study_id