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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02579317
Enrollment
77
Registered
2015-10-19
Start date
2015-11-01
Completion date
2020-06-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorder

Keywords

Baroreflex mechanism, Alcohol Use Disorder, Substance Use Disorder, Heart Rate Variability, Breathing

Brief 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.

Interventions

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.

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

* Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Active Substance Use (Self-report Questionnaire)Three MonthsSelf-reported substance use from the Timeline Follow Back.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer Buckman, Ph.D.

Center of Alcohol Studies

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Baseline characteristics

Characteristic
Active Substance Use16 Participants
Age, Continuous31.6 Years
STANDARD_DEVIATION 8.1
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
13 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
10 Participants
Race (NIH/OMB)
White
32 Participants
Sex: Female, Male
Female
38 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 38
other
Total, other adverse events
0 / 390 / 38
serious
Total, serious adverse events
0 / 390 / 38

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026