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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA023667-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resonance Breathing | Experimental | Breathing is paced to the cardiovascular resonance frequency where heart, respiratory, and brain signals become aligned. This can potentially positively impact cognitive-emotional functioning. |
|
| Non-Resonance Breathing | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resonance Breathing | Behavioral | Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Active Substance Use (Self-report Questionnaire) | Self-reported substance use from the Timeline Follow Back. | Three Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Buckman, Ph.D. | Center of Alcohol Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Alcohol Studies | Piscataway | New Jersey | 08854 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36159943 | Derived | 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. |
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After enrollment, participants first completed a Pre-Intervention phase to be trained on study procedures before being assigned to a group at their first lab session. Participants were withdrawn from the study during this phase if they withdrew from their treatment at the CGE, became pregnant, could not schedule their first lab session, or voluntarily withdrew their participation in the study. Additionally, some participants were withdrawn due to the impact of the COIVD-19 pandemic.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
| FG001 | 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. Non-Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data was missing for 4 participants assigned to the Non-Resonance Breathing group. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Active Substance Use (Self-report Questionnaire) | Self-reported substance use from the Timeline Follow Back. | 7 participants from the resonance breathing group and 3 participants from the non-resonance breathing group were missing Timeline Follow Back data. | Posted | Count of Participants | Participants | Three Months |
|
Adverse event data were collected from screening until the end of follow-up, up to 6 months after enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer F. Buckman, Ph.D. | Rutgers University-New Brunswick | 908-304-3636 | jbuckman@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 24, 2019 | May 19, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2019 | May 19, 2026 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 24, 2019 | May 19, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
| D012120 | Respiration Disorders |
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| Non-Resonance Breathing | Behavioral | Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
|
| 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. Non-Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Active Substance Use | Number of participants who had a positive drug screen at baseline. | Count of Participants | Participants |
|
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.
Non-Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | 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. Non-Resonance Breathing: Breathing is paced with a pre-installed iPhone app that includes a visual pacer. | 0 | 38 | 0 | 38 | 0 | 38 |
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| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Unknown or Not Reported |
|