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

This study is currently recruiting participants.
Verified July 2017 by Jennifer Buckman, Rutgers, The State University of New Jersey
Sponsor:
ClinicalTrials.gov Identifier:
NCT02579317
First Posted: October 19, 2015
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Jennifer Buckman, Rutgers, The State University of New Jersey
  Purpose

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.


Condition Intervention
Substance Use Disorder Behavioral: Resonance Breathing Behavioral: Non-Resonance Breathing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Project IMPACT: In-the-Moment Protection From Automatic Capture by Trigger

Further study details as provided by Jennifer Buckman, Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Active Substance Use (self-report questionnaire) [ Time Frame: Three Months ]

Secondary Outcome Measures:
  • Quality of Life (self-report questionnaire) [ Time Frame: Three Months ]
    Social support, financial resources, etc.


Estimated Enrollment: 170
Study Start Date: November 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579317


Contacts
Contact: Jennifer Buckman, Ph.D. 848-445-0793 jbuckman@rutgers.edu
Contact: Marsha E. Bates, Ph.D. 848-445-3559 mebates@rci.rutgers.edu

Locations
United States, New Jersey
Center of Alcohol Studies Recruiting
Piscataway, New Jersey, United States, 08854
Contact: Jennifer Buckman, Ph.D.    848-445-0793    jbuckman@rutgers.edu   
Contact: Marsha E. Bates, Ph.D.    848-445-3559    mebates@rci.rutgers.edu   
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Jennifer Buckman, Ph.D. Center of Alcohol Studies
  More Information

Responsible Party: Jennifer Buckman, Principal Investigator, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02579317     History of Changes
Other Study ID Numbers: 15-015R
1R01AA023667-01 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2015
First Posted: October 19, 2015
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Jennifer Buckman, Rutgers, The State University of New Jersey:
Baroreflex mechanism
Alcohol Use Disorder
Substance Use Disorder
Heart Rate Variability
Breathing

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders