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
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.
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 →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.
Exclusion Criteria:
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
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
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Active Substance Use (Self-report Questionnaire)
Self-reported substance use from the Timeline Follow Back.
Time frame: Three Months
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.
| Milestone | Resonance Breathing | Non-Resonance Breathing |
|---|---|---|
| Started | 39 | 38 |
| Completed | 30 | 27 |
| Not completed | 9 | 11 |
Self-reported substance use from the Timeline Follow Back.
| Participants | Resonance Breathing | Non-Resonance Breathing |
|---|---|---|
| Active Substance Use (Self-report Questionnaire) | 32 | 35 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resonance Breathing | 0/39 (0%) | 0/39 (0%) | 0/39 (0%) |
| Non-Resonance Breathing | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Age, Continuous(Years) | Resonance Breathing | Non-Resonance Breathing | Total |
|---|---|---|---|
| Mean | 33.0 ± 8.8 | 31.6 ± 8.1 | 32.3 ± 8.5 |
| Sex: Female, Male(Participants) | Resonance Breathing | Non-Resonance Breathing | Total |
|---|---|---|---|
| Female | 39 | 38 | 77 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Resonance Breathing | Non-Resonance Breathing | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 9 | 13 |
| White | 32 | 21 | 53 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 8 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Resonance Breathing | Non-Resonance Breathing | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 6 | 12 |
| Not Hispanic or Latino | 33 | 28 | 61 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Active Substance Use(Participants) | Resonance Breathing | Non-Resonance Breathing | Total |
|---|---|---|---|
| Count of participants | 12 | 16 | 28 |
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Rutgers, The State University of New Jersey