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

NCT02579317 | Completed DMC

• 2 other identifiers: 15-015R1R01AA023667-01
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorder

Keywords

Baroreflex mechanism; Alcohol Use Disorder; Substance Use Disorder; Heart Rate Variability; Breathing

Outcome Measures

Primary Outcomes (1)

• Active Substance Use (self-report questionnaire)

  Three Months

Secondary Outcomes (1)

• Quality of Life (self-report questionnaire)

  Three Months

Study Arms (2)

Resonance Breathing

EXPERIMENTAL

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

Non-Resonance Breathing

PLACEBO COMPARATOR

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

Interventions

Resonance Breathing BEHAVIORAL

Breathing is paced with a pre-installed iPhone app that includes a visual pacer.

Resonance Breathing

Non-Resonance Breathing BEHAVIORAL

Breathing is paced with a pre-installed iPhone app that includes a visual pacer.

Non-Resonance Breathing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women over age 18
• Women diagnosed with substance use disorder
• Women participating in IOP at Center for Great Expectations, New Brunswick, NJ

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Center of Alcohol Studies

Piscataway, New Jersey, 08854, United States

Location

Related Publications (1)

• 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.

  PMID: 36159943 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Alcoholism; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Buckman, Ph.D.

  Center of Alcohol Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 19, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 28, 2022

Record last verified: 2022-03

Locations

US (1)