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NCT03077945 · ClinicalTrials.gov registry record · NA

A Cognitive Behavioral Stress Intervention for Women Who Smoke

A NA study, sponsored by Rutgers, The State University of New Jersey.

Completed
Registry status
NA
Development phase
70
Enrollment target

NCT03077945: Completed NA study, sponsored by Rutgers, The State University of New Jersey.

NCT03077945 is a NA study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03077945, a NA study, has completed, sponsored by Rutgers, The State University of New Jersey.

COMPLETED
Registry status
NA
Development phase
70 participants
Enrollment target

Study Summary

1. PURPOSE OF THE STUDY 1.1 Justification The purpose of the project is to examine the effect of breathing biofeedback and thoughts about stress on performance under stress and cigarette cravings. Smoking rates in the United States have been steadily going down over the past 50 years, and now 16.8% of adults smoke (Centers for Disease Control and Prevention, 2015). Most smokers try to quit, but end up going back to smoking (Garcia-Rodriguez et al., 2013; Piasecki, 2006; Rafful et al., 2013). The reasons people go back to smoking may have something to do with stress in their lives, particularly for women who smoke. This study wants to see if we can reduce temporary stress and lower craving to smoke after stress. 1.2 Description of the Research Project Approximately 60 adult women will participate in the study. Participants must be between 18 and 65 years old, able to read English fluently, and must agree to engage in the research procedures (stress protocol, physiological assessment, breathing training, questionnaires) to participate. People who are taking medications that interfere with physiological assessment are excluded from participating including people with: self-identified substance use problems, self-identified psychosis, morbid obesity (BMI\>40), and people who take anti-cholinergic medication, beta blockers, Ritalin, benzodiazepines, tricyclic antidepressants or bupropion, varenicline, antipsychotic medication, or nicotine replacement therapy. People who have a cardiac rhythm abnormality or major neurological problem are also excluded from the study. Also, participants may not participate if they are pregnant or color-blind. Participation is strictly voluntary. 2. PROGRESSION OF THIS STUDY 2.1 Procedures The study visit procedures will take place at the Emotion and Psychopathology Laboratory at Rutgers University, located at the Rutgers Institute for Health, Healthcare Policy, and Aging Research. Participants will first complete some questionnaires an

Primary Outcome

Change in self-reported craving to smoke a cigarette as reported in the Questionnaire on Smoking Urges - Brief (QSU-B).

Interventions

  • BEHAVIORAL heart rate variability biofeedback and cognitive reappraisal
  • BEHAVIORAL control tasks

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2016-12-01
Est. Completion 2017-05-30
Phase NA

What the finished NCT03077945 record still lists

NCT03077945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which heart rate variability biofeedback and cognitive reappraisal is the first listed.

NCT03077945 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03077945 about?

NCT03077945 is a clinical study titled "A Cognitive Behavioral Stress Intervention for Women Who Smoke". 1. PURPOSE OF THE STUDY 1.1 Justification The purpose of the project is to examine the effect of breathing biofeedback and thoughts about stress on performance under stress and cigarette cravings. Smoking rates in the United States have been steadily going down over the past 50 years, and now 16.8% ...

What is the current status of trial NCT03077945?

This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2016-12-01. Estimated completion is 2017-05-30.

What interventions are being tested in trial NCT03077945?

The interventions under investigation include: heart rate variability biofeedback and cognitive reappraisal (BEHAVIORAL), control tasks (BEHAVIORAL).

Who is sponsoring clinical trial NCT03077945?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03077945's enrollment target sits among peer trials

70 1103rd of 2000 higher than 868 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03077945, the US trial registry maintained by the National Library of Medicine. NCT03077945 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.