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

NCT01362101 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2013-07-11

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • A. Eden Evins

    lead OTHER

Principal Investigators

  • Gladys N Pachas, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01362101 on ClinicalTrials.gov