NCT05488691

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

September 16, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

June 2, 2022

Last Update Submit

September 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • time to relapse

    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)

    2 months

Secondary Outcomes (10)

  • changes in functional connectivity

    2 months

  • percentage of conditioned eyeblink responses (CR)

    2 months

  • CR latency, CR onset, and CR amplitude.

    2 months

  • Hair and salivary cortisol levels

    2 months

  • Craving

    2 months 3 months and 5 months

  • +5 more secondary outcomes

Study Arms (2)

Eye Movement Desensitization and Reprocessing therapy

EXPERIMENTAL

8 to 10 individual 60-minutes sessions over 2 months.

Behavioral: EMDRBehavioral: TAU

Treatment as usual

ACTIVE COMPARATOR

Same periodicity as the experimental group and at the same time range.

Behavioral: TAU

Interventions

EMDRBEHAVIORAL

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.

Eye Movement Desensitization and Reprocessing therapy
TAUBEHAVIORAL

treatment as usual for substance use disorders

Eye Movement Desensitization and Reprocessing therapyTreatment as usual

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Sanchez DF, Blithikioti C, Piazza F, Nuno L, Blanco L, Rodriguez-Rey A, Munoz-Moreno E, Balcells-Olivero M, Miquel L. Eye movement desensitisation and reprocessing as a potential treatment for substance use disorders: study protocol. Eur J Psychotraumatol. 2025 Dec;16(1):2531595. doi: 10.1080/20008066.2025.2531595. Epub 2025 Aug 12.

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Junior Group Leader

Study Record Dates

First Submitted

June 2, 2022

First Posted

August 4, 2022

Study Start

February 1, 2022

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

September 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations