Substance Use Disorder
Conditions
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.
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Active Substance Use (Self-report Questionnaire) | Three Months | Self-reported substance use from the Timeline Follow Back. |
Countries
United States
Contacts
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 Use | 16 Participants |
| Age, Continuous | 31.6 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 type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 38 |
| other Total, other adverse events | 0 / 39 | 0 / 38 |
| serious Total, serious adverse events | 0 / 39 | 0 / 38 |