Clinical trial NCT02579317: Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
Official title: Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Keywords: Baroreflex mechanism
Alcohol Use Disorder
Substance Use Disorder
Heart Rate Variability
Breathing
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2015-10-19
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Active Substance Use (self-report questionnaire)
timeFrame: Three Months
Secondary outcomes:
measure: Quality of Life (self-report questionnaire)
timeFrame: Three Months
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Center of Alcohol Studies
state: New Jersey
Study officials:
affiliation: Center of Alcohol Studies
name: Jennifer Buckman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.