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Heart Rate Variability Biofeedback for Smoking Cessation (HRVB-SCT)

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ClinicalTrials.gov Identifier: NCT03972137
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Teresa M. Leyro, Ph.D., Rutgers, The State University of New Jersey

Brief Summary:
Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling plus transdermal nicotine replacement patch in smokers with elevated emotional distress.

Condition or disease Intervention/treatment Phase
Tobacco Smoking Behavioral: Cognitiive-Behaivoral Smoking Cessation Behavioral: Heart Rate Variability Biofeedback Drug: Nicotine patch Phase 2

Detailed Description:
The investigators propose to develop and pilot test heart rate variability biofeedback for smokers with elevated emotional distress as an adjunct to individual smoking cessation counseling and transdermal nicotine patch. In this open trial, all participants will receive the active intervention. Findings will be used to refine the protocol in advance of a subsequent Phase III randomized clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will be assigned to individualized smoking cessation, nicotine replacement therapy patch, and heart rate variability biofeedback.
Masking: None (Open Label)
Masking Description: This is an open trial with all participants receiving what will become the 'active intervention' in a subsequent randomized clinical trial.
Primary Purpose: Treatment
Official Title: Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
Actual Study Start Date : April 24, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HRVB-SCT
All participants in this open trial will receive individualized cognitive-behavioral smoking cessation treatment, up to 8 weeks of the transdermal nicotine patch, and individualized heart rate variability biofeedback.
Behavioral: Cognitiive-Behaivoral Smoking Cessation
Participants will be provided with five individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.
Other Names:
  • Cognitive-behavioral therapy
  • Smoking cessation counseling

Behavioral: Heart Rate Variability Biofeedback
Heart Rate Variability Biofeedback: All participants will be provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
Other Names:
  • Biofeedback
  • Respiratory biofeedback

Drug: Nicotine patch
All participants will be offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
Other Names:
  • Transdermal nicotine patch
  • Nicotine replacement therapy




Primary Outcome Measures :
  1. Intervention Feasibility: Participant Attendance and Adherence [ Time Frame: Weekly from Week 1 through Week 7 ]
    A composite index of attendance and adherence (e.g., homework completion) will be used to index intervention feasibility, from Week 1 through Week 7 (i.e., end-of-treatment).

  2. Intervention Feasibility, Treatment Initiation: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 1 ]
    Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon treatment initiation.

  3. Intervention Feasibility, End-of Treatment: Participant Ratings of Perceived Effectiveness and Appropriateness [ Time Frame: Week 7, i.e., end-of-treatment ]
    Feasibility will be assessed via participant ratings of perceived effectiveness of the intervention in terms of helping them quit and manage emotional distress, ease of use, and perceived appropriateness of the intervention, upon completing the intervention.

  4. Intervention Acceptability, Treatment Initiation: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 1 ]
    Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon treatment initiation.

  5. Intervention Acceptability, End-of-Treatment: Participant Ratings of Satisfaction and Liking [ Time Frame: Week 7, i.e., end-of-treatment ]
    Acceptability of the intervention will be based on participant ratings of satisfaction and liking of intervention components, upon completing the intervention at Week 7.


Secondary Outcome Measures :
  1. Changes in Smoking Rate [ Time Frame: Week 0 (i.e., baseline), Week 3 (i.e., quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]
    Change in smoking behavior from Week 0 (i.e., baseline) through Week 16 (i.e., 3-months post-quit) will be assessed via the well established Timeline Followback calendar interview.

  2. Smoking Cessation [ Time Frame: Week 3 (i.e, Quit date), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit), and Week 16 (i.e., 3-months post-quit) ]
    Smoking cessation will be based upon self-report and carbon monoxide analysis of breath sample (<5 ppm) at Week 3, i.e., the quit date, and at Week 5, Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit date. Participants whose abstinence is verified via carbon monoxide analysis of breath at Week 16, which occurs approximately five weeks following transdermal nicotine patch termination for those who use the full 8-week course, will provide a saliva sample for cotinine testing to biologically verify abstinence (<12 ng/mL). Participants whose carbon monoxide analysis of breath sample (I.e., Weeks 3, 5, and 7) or cotinine analysis (Week 16) do not indicate abstinence will be coded as smoking.

  3. Change in Total Emotional Distress [ Time Frame: Week 0, Week 5, Week 7, Week 16, i.e., baseline, 2-weeks, 1-month, and 3-months post-quit ]
    Self-reported changes, over time, in total emotional distress will be evaluated via the 21-item, Depression, Anxiety and Stress Scale from Week 0 (i.e., baseline) to Week 5 Week 7, and Week 16, corresponding with 2-weeks, 1-month, and 3-months post-quit. Items will be rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time).



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoking ≥5 cigarettes, daily, for at least two years
  • expired carbon monoxide analysis of breath sample ≥8 ppm
  • elevated affective distress
  • motivation to quit
  • computer proficient

Exclusion Criteria:

  • current use of other tobacco or nicotine products for recreation or to aid in cessation, use of pharmacological intervention for cessation, or current enrollment in a psychosocial intervention for smoking cessation
  • endorsement of current or past psychotic or manic symptoms indicative of bipolar spectrum or schizophrenia spectrum disorders and/or current suicidal or homicidal ideation
  • inability to provide written informed consent
  • current evidence of another substance use disorder
  • severe visual or hearing impairments
  • self-reported medical condition or medication use that may be contraindicated for participation in a HRVB or confound autonomic parameters:
  • self-reported medical issues of potential concern to nicotine patch users

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972137


Contacts
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Contact: Teresa M Leyro, Ph.D. 732-659-4283 teresa.leyro@rutgers.edu
Contact: Mindy Kibbey 732-659-4283 mmk192@scarletmail.rutgers.edu

Locations
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United States, New Jersey
Rutgers, School of Arts and Sciences, One Spring Street Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Teresa Leyro, Ph.D.    732-659-4283 ext 6172231024    teresa.leyro@rutgers.edu   
Contact: Mindy Kibbey    732-659-4283    mmk192@scarletmail.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute on Drug Abuse (NIDA)

Publications:
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Responsible Party: Teresa M. Leyro, Ph.D., Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03972137     History of Changes
Other Study ID Numbers: 2018001848
R34DA043751 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We currently have no plans to share individual participant data from this small open trial as it will be used to guide refinement of a subsequent larger randomized controlled trial.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action