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

March 10, 2022 updated by: Jennifer Buckman, Rutgers, The State University of New Jersey

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Center of Alcohol Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resonance Breathing
Breathing is paced to the cardiovascular resonance frequency where heart, respiratory, and brain signals become aligned. This can potentially positively impact cognitive-emotional functioning.
Behavioral: Resonance Breathing
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
Placebo Comparator: Non-Resonance Breathing
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.
Behavioral: Non-Resonance Breathing
Breathing is paced with a pre-installed iPhone app that includes a visual pacer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Active Substance Use (self-report questionnaire)
Time Frame: Three Months
Three Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (self-report questionnaire)
Time Frame: Three Months
Social support, financial resources, etc.
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jennifer Buckman, Ph.D., Center of Alcohol Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-015R
  • 1R01AA023667-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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