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Cannabis Use DisorderNCT07001371

Emotional Brain Training for Addiction Medicine Treatment - A Pilot Study

A study testing Emotional Brain Training and Standard addiction counseling and medical therapy in people with Cannabis Use Disorder and Stimulant Use Disorder, run by Loma Linda University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Emotional Brain Training and Standard addiction counseling and medical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
Aug 2026to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lori D Karan, MD contact

650-270-5025

lori.karan@va.gov

United States1 site
  • Addiction Recovery Clinic at SAC Health

    San Bernardino, California, 92408

    Brenda Boyle, DNP, 909-382-7100 ext. 4432, bboyle@sachealth.org

Other trials in United States

About this study

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.

Read more

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
Read the detailed description

Background Information and Rationale Addiction is a neuropsychological disorder defined by a persistent and intense urge to use a drug or engage in a behavior that produces a natural reward, despite significant harm and negative consequences. Repetitive substance use alters brain function, perpetuating craving and weakening self-control, while not completely negating it. Addiction is now recognized as a complex brain disorder influenced by both neurobiological and psychosocial factors. Effective treatment typically combines pharmacological approaches with behavioral interventions, such as cognitive behavioral therapy (CBT), psychotherapy, behavior modification strategies, twelve-step programs, and structured residential care.

Emotional Brain Training (EBT) is a method of self-directed neuroplasticity targeting the neural root causes of addiction, rather than substituting one addiction for another. EBT addresses three primary brain-based contributors to addiction:

  1. Replacing self-regulatory failure with optimal brain-based self-regulation, even under stress.
  2. Rewiring maladaptive survival and core circuits to become stress resilient.
  3. Raising the brain's physiological set point from allostatic to homeostatic, supporting adaptive lifestyle changes and reliance on natural rewards.

The core therapeutic technique of EBT is a structured emotional resiliency process that rewires maladaptive circuits through:

  1. Activation of stress-related survival circuits.
  2. Emotional processing to shift circuits from allostatic to homeostatic states.
  3. Conscious identification of maladaptive expectations.
  4. Juxtaposition of adaptive expectations to promote circuit reconsolidation.
  5. Delivery of a dopamine release to solidify the rewiring. This process, consistent with reconsolidation research, is repeated until maladaptive drives and responses are eliminated.

EBT uniquely targets brain circuits that control physiology. The same set of skills is applied by clinicians, in peer-to-peer support, and through self-care with mobile app support, enhancing access and scalability. Delivery occurs through small group telephonic sessions using a confidential platform that fosters learning, community, and coaching.

Group sessions are facilitated by licensed health professionals or certified coaches trained in personal and clinical EBT use. Emotional resiliency processes can be completed rapidly, ranging from two to three minutes for self-regulation to approximately twenty minutes for clinician-facilitated trauma rewiring. Practice is further reinforced through brief peer-to-peer sessions and mobile app exercises.

EBT effectiveness has been evaluated in 14 small studies, demonstrating improvements in psychological measures (such as depression, perceived stress, and self-efficacy), behavioral outcomes (including reduced addictive behaviors and increased exercise), and physiological markers (such as blood pressure and BMI).

Being tested
Emotional Brain Training, Standard addiction counseling and medical therapy
Keywords
early remission, sustained remission
Medical subject headings
Opioid-Related Disorders, Tobacco Use Disorder, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Brain TrainingBehavioural

    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.

  • Standard addiction counseling and medical therapyOther

    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.).

Study groups in NCT07001371
Study groupRoleWhat they receive
Standard of Care (SOC)Active comparatorParticipants 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.
Receives: Other: Standard addiction counseling and medical therapy
Emotional Brain Training (EBT) and Standard of Care (SOC)ExperimentalThis 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.
Receives: Behavioral: Emotional Brain Training; Other: Standard addiction counseling and medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (3)
  1. Change in level of stress (week 4 to 8)

    Level of stress will be measured at three timepoints: baseline (week 0), midpoint (week 4), and study completion (week 8). Responses will be collected using a 10-item perceived stress scale. Each item is rated on a 5-point Likert scale ranging from "Never" to "Very Often." A composite stress score will be calculated at each timepoint, with higher scores reflecting greater perceived stress. The measure evaluates emotional and cognitive responses to stressors, such as unpredictability, lack of control, and feeling overwhelmed. Changes in stress levels will be tracked across the study duration.

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

  2. Change in level of anxiety (week 4 to 8)

    Anxiety will be assessed at baseline, 4 weeks, and 8 weeks using the PROMIS anxiety scale. This 8-item instrument uses a 5-point Likert scale from "Never" to "Always" to evaluate symptoms such as nervousness, tension, and difficulty focusing. A composite anxiety score will be calculated for each assessment point. Higher scores indicate more severe anxiety. Changes will be examined over time to evaluate the trajectory of anxiety symptoms during the intervention.

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

  3. Change in level of cravings (week 4 to 8)

    Craving levels will be measured at weeks 0, 4, and 8 using selected items from the TAPS (Tobacco, Alcohol, Prescription medication, and other Substance use) tool. Participants will report frequency of substance use and associated urges. Responses will be used to generate categorical indicators of craving intensity and frequency. Changes across timepoints will be used to determine patterns in craving reduction or escalation throughout the intervention.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2025
  2. Study startAug 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001371
Sponsor's protocol ID
0000383
Status last verified
Apr 2026
First submitted
23 May 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pilot project. Need specifically qualified EBT trainer for this study.

Publications

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

  • 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.

    PubMed 18654058
  • 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

  • "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.

  • 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.

    PubMed 24459410
  • 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.

    PubMed 33619327
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Brain Training and Standard addiction counseling and medical therapy in people with Cannabis Use Disorder and Stimulant Use Disorder, run by Loma Linda University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brenda Boyle, DNP (909-382-7100 ext. 4432, bboyle@sachealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Level of Stress at 8 weeks (time frame: Change between baseline(time of study enrollment) and Study completion (8 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07001371, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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