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NCT01362101 · ClinicalTrials.gov registry record · Phase 4
Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
A Phase 4 study of Smokers, sponsored by A. Eden Evins.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT01362101: Completed Phase 4 study of Smokers, sponsored by A. Eden Evins.
NCT01362101 is a Phase 4 study of Smokers that has completed, run by A. Eden Evins. The registered enrollment target is 56 participants, above the 46-participant average among 3 other Smokers trials with a reported enrollment target (22% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362101, a Phase 4 study of Smokers, has completed, sponsored by A. Eden Evins.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
* 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-re
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)
Study Locations (1)
Massachusetts
- Center For Addiction Medicine-Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-01 |
| Phase | Phase 4 |
What the finished NCT01362101 record still lists
NCT01362101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, above the 46-participant average among 3 other Smokers trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Smokers appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) is the first listed.
NCT01362101 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01362101 about?
NCT01362101 is a clinical study titled "Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol". 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 th...
What is the current status of trial NCT01362101?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2010-07. Estimated completion is 2012-01.
What conditions does trial NCT01362101 study?
This clinical trial studies the following conditions: Smokers.
What interventions are being tested in trial NCT01362101?
The interventions under investigation include: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01362101?
This trial is sponsored by A. Eden Evins, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01362101 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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