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Completed

NCT Number: NCT05488691

Eye Movement Desensitization and Reprocessing as a Treatment for Substance Use Disorders

Substance Use Disorders (SUD) are often comorbid with psychological trauma, however, the complex interaction between the two is not yet fully understood. Most addiction-specialized professionals do not engage in exploring past traumatic experiences of the patients due to personal, professional, and educational barriers. Therefore, psychological trauma remains highly undetected and its contribution to the development and maintenance of SUD is neglected. This compromises the therapeutic results of most interventions, with relapse rates in SUD still remaining impressively high. EMDR is one of the most effective interventions for Post-Traumatic Stress Disorder (PTSD), and has been applied to other disorders that are often comorbid with trauma, such as psychosis and depression, with promising results. Nevertheless, its application in SUD is still limited. Taken altogether, there is a need to clarify the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy in SUD, as well as the mechanisms of action that mediate its potential therapeutic effects.

The aim of this study is to 1) determine the efficacy of EMDR therapy in patients with SUD comorbid with psychological trauma, as well as whether changes in these clinical variables correspond to changes in salivary cortisol levels- a robust marker of the Hypothalamic-Pituitary-Adrenal (HPA) axis; 2) investigate the mechanisms of action of EMDR therapy, paying special attention to the key role that the cerebellum might play in mediating its therapeutic effects.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A primary DSM-5 diagnosis of moderate to severe SUD, assessed by a clinical interview.
  • No active drug consumption.
  • Having experienced one or more traumatic events, assessed by the Life Event Checklist DSM-5 (LEC-5) and the Childhood Trauma Questionnaire (CTQ).
  • Current posttraumatic symptoms, evaluated with the Impact Event Scale-Revised (IES-R).
  • Aged from 18 to 65 years old.
  • Sign an informed consent to participate in the study.
  • Capable of speaking and comprehending Catalan or Spanish.

Exclusion criteria

  • Having received a trauma-focused therapy within the last 5 years.
  • Severe dissociative symptoms according to the Dissociative Experience Scale (DES).
  • Presence of acute suicidal ideation.
  • Acute episode of a comorbid psychiatric disorder.
  • Severe cognitive impairments.
  • Medical illness that compromises the HPA-axis.
  • Long-term exposure to corticoids.
  • Claustrophobia.
  • Subjects with pacemakers.
  • Presence of metallic objects within the body.
  • Pregnancy

Treatment and study plan

EMDR

Behavioral

The first session consists of recording the patient's history. In the second session the therapist evaluates the presence of coping mechanisms of the patient and, if necessary, suggests extra coping techniques. The following sessions are devoted to the reprocessing process. During these sessions, a target memory is identified and processed using EMDR. After a total of 8-10 sessions, it is expected that the patient will have achieved physiological reconciliation, relieved distress, and the ability to reformulate negative beliefs.

TAU

Behavioral

treatment as usual for substance use disorders

Primary outcomes

  1. time to relapse

    Time frame: 2 months

    Relapse is defined as a return to the addictive behavior, different from a punctual consumption, which is considered as a lapse. This will bee measured by the Time Line Follow Back self-report (TLFB)

Secondary outcomes

  1. changes in functional connectivity

    Time frame: 2 months

    measured by resting-state fMRI

  2. percentage of conditioned eyeblink responses (CR)

    Time frame: 2 months

    measured by the Eyeblink Conditioning System

  3. CR latency, CR onset, and CR amplitude.

    Time frame: 2 months

    measured by the Eyeblink Conditioning System

  4. Hair and salivary cortisol levels

    Time frame: 2 months

    Comparison of the Area Under the Curve pre and post treatment

  5. Craving

    Time frame: 2 months 3 months and 5 months

    Self-report measurement

  6. Total amount of substance consumed during the previous month

    Time frame: 2 months, 3 months and 5 months

    measured by the TLFB

  7. Changes in depressive symptomatology

    Time frame: 2 months, 3 months and 5 months

    measured by Beck's Depression Inventory (BDI)

  8. Changes in anxious symptomatology

    Time frame: 2 months, 3 months and 5 months

    measured by The State-Trait Anxiety Inventory (STAI)

  9. Changes in posttraumatic symptomatology

    Time frame: 2 months, 3 months and 5 months

    measured by Clinician-Administered PTSD Scale (CAPS)

  10. Changes in global functioning

    Time frame: 2 months, 3 months and 5 months

    measured by Functioning Assessment Short Test (FAST)

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

What Works and Why? Eye Movement Desensitization and Reprocessing as a Potential Treatment for Substance Use Disorders

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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