Tobacco SmokingPhase 2HRVB-SCTNCT03972137

Heart Rate Variability Biofeedback for Smoking Cessation

A Phase 2 study testing Cognitive-Behavioral Smoking Cessation, Heart Rate Variability Biofeedback (HRVB) and Transdermal Nicotine patch in people with Tobacco Smoking, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open trial of heart rate variability biofeedback as an adjunct to individualized smoking cessation counseling (SCT) plus transdermal nicotine replacement patch (NRT) in smokers with elevated emotional distress. Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Smoking
What is being tested?: Cognitive-Behavioral Smoking Cessation, Heart Rate Variability Biofeedback (HRVB) and Transdermal Nicotine patch
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2019to 20 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers, School of Arts and Sciences, One Spring Street
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation

Read the detailed description

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

Conditions: Tobacco Smoking
Being tested: Cognitive-Behavioral Smoking Cessation, Heart Rate Variability Biofeedback (HRVB), Transdermal Nicotine patch
Keywords: Smoking Cessation, Heart rate variability biofeedback
Medical subject headings: Tobacco Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive-Behavioral Smoking CessationBehavioural
Also called Cognitive-behavioral therapy, Smoking cessation counseling (SCT)
Participants were provided with six 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.
Heart Rate Variability Biofeedback (HRVB)Behavioural
Also called Biofeedback, Respiratory biofeedback
All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
Transdermal Nicotine patchDrug
Also called Nicotine patch, Nicotine replacement therapy (NRT)
All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.

Study groups in NCT03972137
Study group	Role	What they receive
Heart Rate Variability Biofeedback-Smoking Cessation Therapy	Experimental	All participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB). Receives: Behavioral: Cognitive-Behavioral Smoking Cessation; Behavioral: Heart Rate Variability Biofeedback (HRVB); Drug: Transdermal Nicotine patch

What is being measured

The primary outcome is the main question the study is designed to answer.

Intervention Feasibility: Participant Attendance
Number of intervention sessions attended out of 10 possible sessions.
Measured: 7 weeks
Intervention Feasibility: Participant Ratings of Effectiveness
Effectiveness was assessed via self-report ratings on four items assessing the intervention in terms of helping them quit and manage emotional distress, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater perceived intervention efficacy. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Measured: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Intervention Feasibility: Participant Ratings of Appropriateness
Appropriateness was assessed via self-report ratings on two items assessing the intervention in terms of comprehension and fit, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater perceived intervention appropriateness. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Measured: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Intervention Feasibility: Participant Ratings of Ease of the Intervention
Ease of the Intervention was assessed via self-report ratings on three items assessing ease of use and fit into daily lifestyle, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater perceived ease of the intervention and fit into daily lifestyle. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Measured: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Intervention Acceptability: Participant Ratings of Satisfaction and Liking
Satisfaction and liking were assessed via self-report ratings on five items assessing satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to friends, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater intervention acceptability. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Measured: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)

Secondary outcomes (3)

Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)
Quit status was assessed on Quit day via self-reported abstinence and carbon monoxide analysis of breath sample (CO <8 ppm). Given carbon monoxide analysis of breath may not be a valid indicator of cessation within the first 24 hours, we suggest interpretation of this outcome on Quit day with caution.
Sustained smoking cessation was evaluated at study termination (i.e., 3-month follow-up) via self-reported abstinence, carbon monoxide analysis ( CO <8 ppm), and salivary cotinine (<10 ng/mL).
Measured: Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Cigarettes Smoked Per Day
Cigarettes Smoked Per Day (CPD) assessed via the well established Timeline Followback calendar interview were used to measure changes in smoking behavior from Week 0 (i.e., Baseline) through Week 3 (i.e., Quit date) and Week 16 (i.e., 3-month follow-up).
Measured: Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Change in Total Emotional Distress
Self-reported change in emotional distress was evaluated via the 21-item, Depression, Anxiety and Stress Scale (DASS-21). The DASS-21 is composed of three self-report scales that measure the emotional states of depression, anxiety and stress. Items are 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). Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. The severity ratings are as follows Depression: Normal 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, Extremely Severe: 14-21. Stress: Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, Extremely Severe: 17-21. Anxiety: Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, Extremely Severe: 10-21. Total scores are computed by summing the subscales. Total scores for the DASS-21 range from 0-63. For all scales, higher scores are indicative of greater emotional distress and less change in total distress symptoms over time.
Measured: Week 0 (i.e., baseline), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit) and Week 16 (i.e., 3-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 201920 Feb 2020

First posted3 Jun 2019
Study start24 Apr 2019
Primary completion20 Feb 2020
Study completion20 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tobacco SmokingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03972137
Sponsor's protocol ID: 2018001848
Other IDs: R34DA043751
Acronym: HRVB-SCT
Status last verified: Aug 2020
First submitted: 20 May 2019
Last updated: 25 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Leyro TM, Buckman JF, Bates ME. Theoretical implications and clinical support for heart rate variability biofeedback for substance use disorders. Curr Opin Psychol. 2019 Dec;30:92-97. doi: 10.1016/j.copsyc.2019.03.008. Epub 2019 Apr 2.
PubMed 31055246

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Pilot Investigation of Heart Rate Variability Biofeedback for Smoking Cessation
ClinicalTrials.gov ID: NCT03972137
Acronym / sponsor ID: HRVB-SCT / 2018001848
Conditions: Tobacco Smoking
Keywords: Smoking Cessation, Heart rate variability biofeedback
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 24 Apr 2019 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 20 Feb 2020 (actual)
First posted: 3 Jun 2019 (actual)
Results: Posted 25 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants received individualized smoking cessation therapy (SCT), nicotine replacement therapy patch (NRT) and heart rate variability biofeedback (HRVB).

Arm	Type	Receives
Heart Rate Variability Biofeedback-Smoking Cessation Therapy	Experimental	Behavioral: Cognitive-Behavioral Smoking Cessation, Behavioral: Heart Rate Variability Biofeedback (HRVB), Drug: Transdermal Nicotine patchAll participants in this open trial received individualized cognitive-behavioral smoking cessation treatment (SCT), up to 8 weeks of the transdermal nicotine patch (NRT) and individualized heart rate variability biofeedback (HRVB).

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive-Behavioral Smoking CessationAlso: Cognitive-behavioral therapy, Smoking cessation counseling (SCT)Participants were provided with six 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.	Behavioural	Heart Rate Variability Biofeedback-Smoking Cessation Therapy
Heart Rate Variability Biofeedback (HRVB)Also: Biofeedback, Respiratory biofeedbackAll participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.	Behavioural	Heart Rate Variability Biofeedback-Smoking Cessation Therapy
Transdermal Nicotine patchAlso: Nicotine patch, Nicotine replacement therapy (NRT)All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.	Drug	Heart Rate Variability Biofeedback-Smoking Cessation Therapy

Primary outcome

Intervention Feasibility: Participant Attendance
Time frame: 7 weeks
Number of intervention sessions attended out of 10 possible sessions.
Intervention Feasibility: Participant Ratings of Effectiveness
Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Effectiveness was assessed via self-report ratings on four items assessing the intervention in terms of helping them quit and manage emotional distress, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater perceived intervention efficacy. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Intervention Feasibility: Participant Ratings of Appropriateness
Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Appropriateness was assessed via self-report ratings on two items assessing the intervention in terms of comprehension and fit, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater perceived intervention appropriateness. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Intervention Feasibility: Participant Ratings of Ease of the Intervention
Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Ease of the Intervention was assessed via self-report ratings on three items assessing ease of use and fit into daily lifestyle, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater perceived ease of the intervention and fit into daily lifestyle. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.
Intervention Acceptability: Participant Ratings of Satisfaction and Liking
Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up)
Satisfaction and liking were assessed via self-report ratings on five items assessing satisfaction with learning the intervention, liking the intervention, breathing techniques, nicotine replacement, and recommending the intervention to friends, rated on a 0=completely disagree to 4=completely agree Likert-type scale. Higher scores on this scale are indicative of greater intervention acceptability. Mean scores obtained following the first intervention session and 3-month follow-up session are reported.

3 secondary outcomes

Number of Participants With Self-Reported Abstinence, Cotinine Verified Abstinence, and Carbon Monoxide Analysis of Breathe Sample (CO < 8ppm)
Time frame: Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Cigarettes Smoked Per Day
Time frame: Week 0 (i.e., baseline), Week 3 (i.e., Quit Date) and Week 16 (i.e., 3-month follow-up)
Change in Total Emotional Distress
Time frame: Week 0 (i.e., baseline), Week 5 (i.e., 2-weeks post-quit), Week 7 (i.e., 1-month post-quit) and Week 16 (i.e., 3-month follow-up)

Results and safety

Results posted to the registry on 25 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Heart Rate Variability Biofeedback- Smoking Cessation Therapy	10	4

Primary outcome: Intervention Feasibility: Participant Attendance

Time frame: 7 weeks. Mean (Standard Deviation). Unit: Sessions

Measure	Intent-to-treat (ITT) n = 10	Remained in Treatment Beyond One Session n = 7
Value	6.30 (4.08)	8.71 (1.49)

Population analysed: Data on both the Intent-to-treat (ITT) N=10 participants who completed the baseline session and were enrolled in the study and the n=7 who received more than one Heart Rate Variability Biofeedback Session (HRVB) and one Smoking Cessation Treatment (SCT) session (i.e. which occurred during their first intervention appointment) are reported.

Primary outcome: Intervention Feasibility: Participant Ratings of Effectiveness

Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up). Mean (Standard Deviation). Unit: score on a scale

Measure	First Session n = 9	3-month Follow-up (3MFU) n = 4
Value	3.03 (0.83)	3.19 (0.52)

Population analysed: Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=4 attended their 3-month follow-up.

Primary outcome: Intervention Feasibility: Participant Ratings of Appropriateness

Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up). Mean (Standard Deviation). Unit: score on a scale

Measure	First Session n = 9	3-month Follow-up (3MFU) n = 4
Value	3.61 (0.69)	2.87 (0.75)

Population analysed: Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=4 attended their 3-month follow-up.

Primary outcome: Intervention Feasibility: Participant Ratings of Ease of the Intervention

Time frame: Week 1 (i.e., treatment initiation) and Week 16 (i.e., 3-month follow-up). Mean (Standard Deviation). Unit: score on a scale

Measure	First Session n = 9	3-month Follow-up (3MFU) n = 4
Value	2.4 (0.84)	1.58 (0.32)

Population analysed: Of the N=10 participants who were enrolled in the study, n=9 completed this measure following their baseline appointment; n=4 attended their 3-month follow-up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline (i.e. Week 0), End of Treatment (i.e. Week 7, 1-month post-quit), 3-month follow-up (i.e. Week 16). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolled	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31055246Leyro TM, Buckman JF, Bates ME. Theoretical implications and clinical support for heart rate variability biofeedback for substance use disorders. Curr Opin Psychol. 2019 Dec;30:92-97. doi: 10.1016/j.copsyc.2019.03.008. Epub 2019 Apr 2.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teresa Leyro, Ph.D. principal investigator

Rutgers, The State University of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention Feasibility: Participant Attendance (time frame: 7 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972137, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.