Substance Use DisorderNCT02579317
Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
A study testing Resonance Breathing and Non-Resonance Breathing in people with Substance Use Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Resonance Breathing and Non-Resonance Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2020
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over age 18
- Women diagnosed with substance use disorder
- Women participating in IOP at Center for Great Expectations, New Brunswick, NJ
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Center of Alcohol Studies
Piscataway, New Jersey, 08854
About this study
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.
Read more
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.
- Conditions
- Substance Use Disorder
- Being tested
- Resonance Breathing, Non-Resonance Breathing
- Keywords
- Baroreflex mechanism, Alcohol Use Disorder, Substance Use Disorder, Heart Rate Variability, Breathing
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resonance BreathingBehavioural
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Non-Resonance BreathingBehavioural
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resonance Breathing |
| 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. Receives: Behavioral: Non-Resonance Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Substance Use (Self-report Questionnaire)
Self-reported substance use from the Timeline Follow Back.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2020
- Study completionJun 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 Substance Use DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jennifer Buckman, Rutgers, The State University of New Jersey
- Investigators
- Jennifer Buckman, Ph.D., Principal investigator, Center of Alcohol Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579317
- Sponsor's protocol ID
- 15-015R
- Other IDs
- 1R01AA023667-01
- Status last verified
- May 2026
- First submitted
- 13 Oct 2015
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
- ClinicalTrials.gov ID
- NCT02579317
- Acronym / sponsor ID
- 15-015R
- Conditions
- Substance Use Disorder
- Keywords
- Baroreflex mechanism, Alcohol Use Disorder, Substance Use Disorder, Heart Rate Variability, Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2015
- Primary completion
- Mar 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Posted 15 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resonance Breathing | Experimental | Behavioral: Resonance BreathingBreathing 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 | Behavioral: Non-Resonance BreathingBreathing is paced at a non-resonance frequency. It does not align heart, respiratory, and brain signals, and thus does not impact cognitive-emotional functioning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over age 18
- Women diagnosed with substance use disorder
- Women participating in IOP at Center for Great Expectations, New Brunswick, NJ
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Resonance BreathingBreathing is paced with a pre-installed iPhone app that includes a visual pacer. | Behavioural | Resonance Breathing |
| Non-Resonance BreathingBreathing is paced with a pre-installed iPhone app that includes a visual pacer. | Behavioural | Non-Resonance Breathing |
Primary outcome
Active Substance Use (Self-report Questionnaire)
Time frame: Three Months
Self-reported substance use from the Timeline Follow Back.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36159943Price 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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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.
Jennifer Buckman, Ph.D. principal investigator
Center of Alcohol Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resonance Breathing and Non-Resonance Breathing in people with Substance Use Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 3 inclusion and 1 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 15 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). 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?
Active Substance Use (Self-report Questionnaire) (time frame: Three Months). 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 NCT02579317, 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 15 Jun 2026.