Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study

NCT07001371 | Not Yet Recruiting

• 1 other identifier: 0000383
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine whether Emotional Brain Training (EBT), a behavioral modification method, can help manage stress and health problems related to addiction. EBT teaches skills to deactivate harmful circuits (automatic reactions) and activate healing circuits to quickly shift mood from negative to positive. Participants in the EBT group will receive focused, intensive instruction on using these skills to rewire unwanted brain circuits, with the aim of achieving lasting improvements in emotional health and quality of life. The study will assess whether EBT is an effective tool when added to standard of care (SOC), which includes medications for addiction treatment (MAT). Researchers will compare changes in stress, anxiety, and cravings after 8 weeks of EBT plus SOC versus SOC alone. Participants:

• will either continue receiving standard treatments (SOC) at the Addiction Recovery Clinic (ARC) at SAC Health in San Bernardino
• or receive both EBT and SOC at ARC
• in the SOC group will continue monthly visits at ARC and weekly counseling
• in the EBT plus SOC group will continue monthly visits and weekly counseling at ARC, along with weekly EBT group sessions by telephone
• will complete online assessments at weeks 0, 4, and 8 Upon completion of the study, all participants will resume SOC

Conditions

Alcohol Use Disorder; Tobacco Use Disorder; Cannabis Use Disorder; Stimulant Use Disorder; Opioid Use Disorder; Sedative, Hypnotic, or Anxiolytic Use Disorders

Keywords

early remission; sustained remission

Outcome Measures

Primary Outcomes (3)

• Changes in Level of Stress at 8 weeks

  Level of stress will be measured by comparing scores from baseline to study completion. Responses will be collected using a 10-item survey assessing perceived stress, administered at enrollment and at eight weeks post-enrollment. Each item uses a 5-point Likert scale ranging from "Never" to "Very Often." Scores will be summed to create a composite stress score, with higher scores indicating greater perceived stress. This measurement evaluates how often participants experience emotional and cognitive responses to stressors such as lack of control, feeling overwhelmed, or being unable to cope.

  Change between baseline(time of study enrollment) and Study completion (8 weeks).

• Changes of Level of Anxiety at 8 weeks

  Level of anxiety will be assessed using a standardized PROMIS anxiety scale. Participants will complete the survey at baseline and again at the end of the eight-week study period. The survey consists of 8 items rated on a 5-point Likert scale from "Never" to "Always." Items measure frequency of symptoms such as nervousness, tension, and difficulty concentrating due to anxiety. A composite score will be calculated, with higher values reflecting more severe anxiety symptoms.

  Change between baseline(time of study enrollment) and Study completion (8 weeks).

• Change in Levels of Cravings

  Level of cravings will be measured using selected items from the TAPS (Tobacco, Alcohol, Prescription medication, and other Substance use) assessment tool. Participants will report frequency of use and urges related to substance use at baseline and again at the end of the eight-week period. Responses will be categorized to identify changes in craving intensity and frequency. Increased scores suggest more frequent or intense cravings, while lower scores indicate a reduction in craving-related behaviors or urges.

  Change between baseline(time of study enrollment) and Study completion (8 weeks).

Secondary Outcomes (3)

• Change in level of stress (week 4 to 8)

  Change between mid-point(week 4) and Study completion (8 weeks).

• Change in level of anxiety (week 4 to 8)

  Change between mid-point(week 4) and Study completion (8 weeks).

• Change in level of cravings (week 4 to 8)

  Change between mid-point(week 4) and Study completion (8 weeks).

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

Participants will receive SOC, which includes medications for addiction therapy (MAT) (including but not limited to buprenorphine, naltrexone, bupropion, etc.) weekly counseling, and monthly clinic visits with addiction specialists.

Other: Standard addiction counseling and medical therapy

Emotional Brain Training (EBT) and Standard of Care (SOC)

EXPERIMENTAL

This group will receive all the components of SOC plus EBT counseling: A. The components below will be completed daily and is estimated to take 25 minutes: i. \[10 1-minute spiral ups (SU) - an EBT specific, app-directed methodology of emotional regulation\], plus; ii. 5 minutes via telephone for a group peer connection iii. 10 minutes online/phone app coursework/video B. Once a week: participants will participate in a 60 minute small-group telephone meeting for accountability and support C. Once a week: participants will participate in at least 3 30-minute Spiral Up (SU) groups/week to practice the skills. These are available online daily.

Behavioral: Emotional Brain Training; Other: Standard addiction counseling and medical therapy

Interventions

Emotional Brain Training BEHAVIORAL

Emotional Brain Training (EBT) is a structured, neuroscience-based behavioral intervention that focuses on rewiring the brain's stress-related circuits to promote emotional resilience, self-regulation, and lasting behavioral change. This behavioral intervention has not been implemented in addiction treatments in the past. Unlike traditional therapies that primarily target cognitive processes or symptom management, EBT directly addresses the physiological and emotional root causes of maladaptive behaviors by engaging the brain's natural neuroplasticity mechanisms. EBT integrates rapid emotional processing tools, peer-to-peer support, clinician-facilitated sessions, and mobile app-based self-care to systematically transition brain circuits from stress-reactive to stress-resilient states.

Emotional Brain Training (EBT) and Standard of Care (SOC)

Standard addiction counseling and medical therapy OTHER

Participants will receive standard counseling (including but not limited to cognitive behavioral therapy, motivational interviewing, etc.), which does not include EBT, in addition to medications for addiction treatment (including but not limited to buprenorphine, naltrexone, bupropion, etc.).

Emotional Brain Training (EBT) and Standard of Care (SOC); Standard of Care (SOC)

Eligibility Criteria

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

You may qualify if:

• Age 18 years old or older
• Patient can speak and read English
• Patient who receives regular MAT care at SAC Health
• Patients who have regular and reliable cellular and/or reliable internet connection
• Patients who are willing to spend average of 25 minutes per day and attend weekly group meetings
• Patients willing to actively participate in group sessions
• Opioid use disorder, at least in early remission
• Alcohol use disorder, at least in early remission
• Methamphetamine use disorder, at least in early remission
• Cocaine use disorder, at least in early remission
• Anxiolytic use disorder, at least in early remission
• Cannabis use disorder
• Tobacco use disorder

You may not qualify if:

• Age \<18 years old
• Patient does not speak or read English
• Patients who do not seek regular MAT care at SAC Health
• Patients with inconsistent or no access to cellular or internet connection
• Any disorder that is uncontrolled
• Any substance use disorder not in at least early remission
• Any patient with complications related to use disorder
• Patients enrolled in the Coachella Valley Rescue Mission patients a part of SAC Health
• Anyone who, in the opinion of the investigators, would be unable to participate in an 8-week trial

Sponsors & Collaborators

• Social Action for Health: collaborator
• Loma Linda University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Addiction Recovery Clinic at SAC Health

San Bernardino, California, 92408, United States

Location

Related Publications (7)

• Mellin L, Fish-dePena LE, Frassetto LA, Mitrovic I. Rewiring the stress response: A new paradigm for health care. Medical Hypothesis 9(1), 2011.

  BACKGROUND

• Clay SW, Allen J, Parran T. A review of addiction. Postgrad Med. 2008 Jul 31;120(2):E01-7. doi: 10.3810/pgm.2008.07.1802.

  PMID: 18654058 BACKGROUND

• Henden E (2017). Addiction, compulsion, and weakness of the will: A dual-process perspective.. In Heather N, Gabriel S (eds.). Addiction and Choice: Rethinking the Relationship. Oxford, UK: Oxford University Press. pp. 116-132

  BACKGROUND

• "Drugs, Brains, and Behavior: The Science of addiction - Drug misuse and addiction. www.drugabuse.gov. North Bethesda, Maryland: National Institute on Drug Abuse. 13 July 2020. Retrieved 23 December 2021.

  BACKGROUND

• Nestler EJ. Cellular basis of memory for addiction. Dialogues Clin Neurosci. 2013 Dec;15(4):431-43. doi: 10.31887/DCNS.2013.15.4/enestler.

  PMID: 24459410 BACKGROUND

• Heilig M, MacKillop J, Martinez D, Rehm J, Leggio L, Vanderschuren LJMJ. Addiction as a brain disease revised: why it still matters, and the need for consilience. Neuropsychopharmacology. 2021 Sep;46(10):1715-1723. doi: 10.1038/s41386-020-00950-y. Epub 2021 Feb 22.

  PMID: 33619327 BACKGROUND

• Ford J, Frassetto L, Mellin L. Emotional Brain Training (EBT) in Subjects after Bariatric Surgery. American Society of Bariatric Surgery, Virginia Beach 8.19.23 abstract - first place.

  RESULT

Related Links

• website describing EBT

MeSH Terms

Conditions

Opioid-Related Disorders; Tobacco Use Disorder; Alcoholism

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Alcohol-Related Disorders

Central Study Contacts

Brenda Boyle, DNP

CONTACT

909-382-7100; bboyle@sachealth.org

Lori D Karan, MD

CONTACT

650-270-5025; lori.karan@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 8 weeks of Standard of Care (SOC) addiction treatment versus SOC plus Emotional Brain Training (EBT). Subjects are patients currently receiving SOC at the Addiction Recovery Clinic at SAC Health. As part of SOC, participants will complete the Brief Addiction Monitor (BAM) tool at weeks 0, 4, and 8, and the Adverse Childhood Events (ACES) survey at week 0. Providers at the clinic will approach subjects regarding participation in the study. Subjects randomized to the EBT arm will receive 8 weeks of the standard EBT intervention, which includes: Subjects randomized to the control arm, in addition to SOC, will have access to: * Individual case management services * Drug and alcohol counseling * The opportunity to transition to the EBT arm after completion of two months in the control arm

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)