CClinicalTrials.gg
CompletedNCT02579317Updated Jun 15, 2026Results posted

Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger

An interventional study of Resonance Breathing and Non-Resonance Breathing in Substance Use Disorder, sponsored by Rutgers, The State University of New Jersey. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Despite conscious intentions to remain abstinent, persons with substance use disorders often find that negative emotions and environmental cues automatically "trigger" drinking and other substance use. This study aims to test whether activating the baroreflex mechanism can be used "in the moment" to help resist drinking triggers. It consists of 3 phases (Recruitment, Intervention, Follow-up).

Stage 1: Trained research staff conduct a comprehensive clinical interview and questionnaires to assess participant's mood, substance use, and triggers. Participants are paired with a Primary Research Clinician (PRC) who will work with them during the intervention.

Stage 2: Approximately 4 weeks after intake into the Center for Great Expectations Intensive Outpatient program, an 8-week intervention begins. Pre-and post-intervention laboratory sessions occur at Cardiac Neuroscience Laboratory, Center of Alcohol Studies, Piscataway, NJ. Some participants take part in pre- and post-intervention neuroimaging sessions (Rutgers University Brain Imaging Center, Newark, NJ). Participants are randomized into an active intervention or control group after the pre-intervention lab session. They are given an iPhone and trained to use a paced breathing app that is pre-loaded onto the phone. Participants in both groups use their app any time they anticipate or experience a trigger to drink or use drugs. Participants are compensated for their use of the app and the time for participation. To ensure that participants are correctly performing the paced breathing task, their PRC visit with them weekly to provide coaching sessions using a computer-based biofeedback program. During the 4th week, ECG and respiration data are collected. Participants also complete questionnaires about mood and triggers, and provide feedback on the usefulness of the app.

During the lab sessions, participants complete a series of questionnaires and ECG, blood pressure and respiration are collected during four 5-minute tasks (resting baseline, non-resonance breathing, resonance breathing, and visual processing/attention). During the neuroimaging sessions, participants are placed in the scanner for structural scans and four 5-minute tasks (as tasks as previously noted); ECG and blood pressure are recorded.

Stage 3: Participants are re-contacted 1 and 3 months after the intervention to complete questionnaires about their quality of life across multiple domains and the usefulness of the app.

02

Conditions studied

  • Substance Use Disorder

Keywords

  • Baroreflex mechanism
  • Alcohol Use Disorder
  • Substance Use Disorder
  • Heart Rate Variability
  • Breathing
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 77 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women over age 18
  • Women diagnosed with substance use disorder
  • Women participating in IOP at Center for Great Expectations, New Brunswick, NJ

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
77 participants (actual)

Study arms

  • Experimental
    Resonance Breathing

    Breathing is paced to the cardiovascular resonance frequency where heart, respiratory, and brain signals become aligned. This can potentially positively impact cognitive-emotional functioning.

    Behavioral: Resonance Breathing

  • Placebo comparator
    Non-Resonance Breathing

    Breathing is paced at a non-resonance frequency. It does not align heart, respiratory, and brain signals, and thus does not impact cognitive-emotional functioning.

    Behavioral: Non-Resonance Breathing

Interventions

  • BehavioralResonance Breathing

    Breathing is paced with a pre-installed iPhone app that includes a visual pacer.

  • BehavioralNon-Resonance Breathing

    Breathing is paced with a pre-installed iPhone app that includes a visual pacer.

06

What researchers measure

Primary outcomes

  1. Active Substance Use (Self-report Questionnaire)

    Self-reported substance use from the Timeline Follow Back.

    Time frame: Three Months

07

Results

Posted Jun 15, 2026
Limitations and caveats
The effect of the intervention could not be determined due to the influences of the opioid epidemic that severally restricted recruitment of participants with primary alcohol use disorders and the nationwide shutdowns that occurred due to the COVID-19 pandemic. The final sample was statistically underpowered ; thus, analyses focused on the uptake of the intervention by individuals in outpatient treatment for opioid and other use disorders.

Participant flow

Participants were recruited from the Center for Great Expectations (CGE) in Somerset, NJ. Those who completed their intake for alcohol use disorder at the CGE were consented and screened for eligibility.

Participant flow — Overall Study
MilestoneResonance BreathingNon-Resonance Breathing
Started3938
Completed3027
Not completed911

Outcome measures

PrimaryActive Substance Use (Self-report Questionnaire)

Self-reported substance use from the Timeline Follow Back.

Time frame:
Three Months
Reported as:
Count of participants · Participants
Active Substance Use (Self-report Questionnaire)
ParticipantsResonance BreathingNon-Resonance Breathing
Active Substance Use (Self-report Questionnaire)3235
Statistical analysis
  • Resonance Breathing vs Non-Resonance Breathing · t-test, 2 sided · p = 0.37

Adverse events

Collected over Adverse event data were collected from screening until the end of follow-up, up to 6 months after enrollment.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Resonance Breathing0/39 (0%)0/39 (0%)0/39 (0%)
Non-Resonance Breathing0/38 (0%)0/38 (0%)0/38 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Resonance BreathingNon-Resonance BreathingTotal
Mean33.0 ± 8.831.6 ± 8.132.3 ± 8.5
Sex: Female, Male
Sex: Female, Male(Participants)Resonance BreathingNon-Resonance BreathingTotal
Female393877
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Resonance BreathingNon-Resonance BreathingTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American4913
White322153
More than one race101
Unknown or Not Reported2810
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Resonance BreathingNon-Resonance BreathingTotal
Hispanic or Latino6612
Not Hispanic or Latino332861
Unknown or Not Reported044
Active Substance Use
Active Substance Use(Participants)Resonance BreathingNon-Resonance BreathingTotal
Count of participants121628
08

Study locations

1 site
  • Center of Alcohol Studies
    Piscataway, New Jersey 08854, United States
09

References and documents

Publications

  • Price JL, Bates ME, Pawlak AP, Uhouse SG, Todaro SM, Morgano J, Buckman JF. Use and perceived usefulness of a just-in-time resonance breathing intervention adjunct for substance use disorder: Contextual and physiological predictors. Front Psychiatry. 2022 Sep 7;13:945751. doi: 10.3389/fpsyt.2022.945751. eCollection 2022. PubMed 36159943 ↗

Study documents

  • Study protocol · Jul 24, 2019
  • Statistical analysis plan · Jul 24, 2019
  • Informed consent form · Jul 24, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02579317
Lead sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Jennifer Buckman (Principal Investigator, Rutgers, The State University of New Jersey) — Principal investigator
First posted
Oct 19, 2015
Start date
Nov 2015
Primary completion
Mar 2020
Completion
Jun 2020
Results posted
Jun 15, 2026
Last update
Jun 15, 2026

Study contacts

Jennifer Buckman, Ph.D.
principal investigator · Center of Alcohol Studies

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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