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NCT02579317 · ClinicalTrials.gov registry record · NA
Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger
A NA study of Substance Use Disorder, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- NA
- Development phase
- 107
- Enrollment target
- 1
- Study location
NCT02579317: Completed NA study of Substance Use Disorder, sponsored by Rutgers, The State University of New Jersey.
NCT02579317 is a NA study of Substance Use Disorder that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 107 participants, below the 816-participant average among 18 other Substance Use Disorder trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579317, a NA study of Substance Use Disorder, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- NA
- Development phase
- 107 participants
- Enrollment target
- 1
- Study location
Study 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-minut
Primary Outcome
Self-reported substance use from the Timeline Follow Back.
Conditions Studied
Interventions
- BEHAVIORAL Resonance Breathing
- BEHAVIORAL Non-Resonance Breathing
Study Locations (1)
New Jersey
- Center of Alcohol Studies - Piscataway
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2015-11 |
| Est. Completion | 2020-06 |
| Phase | NA |
What the finished NCT02579317 record still lists
NCT02579317 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 816-participant average among 18 other Substance Use Disorder trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Substance Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Resonance Breathing is the first listed.
NCT02579317 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT02579317 about?
NCT02579317 is a clinical study titled "Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger". 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...
What is the current status of trial NCT02579317?
This trial is currently completed. It is a NA study. The enrollment target is 107 participants. The study started on 2015-11. Estimated completion is 2020-06.
What conditions does trial NCT02579317 study?
This clinical trial studies the following conditions: Substance Use Disorder.
What interventions are being tested in trial NCT02579317?
The interventions under investigation include: Resonance Breathing (BEHAVIORAL), Non-Resonance Breathing (BEHAVIORAL).
Who is sponsoring clinical trial NCT02579317?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02579317 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02579317's enrollment target sits among peer trials
107 12th of 18 higher than 7 of 18 other Substance Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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