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

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488691
• Other study ID #: PI20/00506
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Hospital Clinic of Barcelona
• Contact: Laia Miquel de Montagut
• Phone: +34932275400
• Email: miquel[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• EMDR
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
treatment as usual for substance use disorders

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes in functional connectivity	measured by resting-state fMRI	2 months
Secondary	percentage of conditioned eyeblink responses (CR)	measured by the Eyeblink Conditioning System	2 months
Secondary	CR latency, CR onset, and CR amplitude.	measured by the Eyeblink Conditioning System	2 months
Secondary	Hair and salivary cortisol levels	Comparison of the Area Under the Curve pre and post treatment	2 months
Secondary	Craving	Self-report measurement	2 months 3 months and 5 months
Secondary	Total amount of substance consumed during the previous month	measured by the TLFB	2 months, 3 months and 5 months
Secondary	Changes in depressive symptomatology	measured by Beck's Depression Inventory (BDI)	2 months, 3 months and 5 months
Secondary	Changes in anxious symptomatology	measured by The State-Trait Anxiety Inventory (STAI)	2 months, 3 months and 5 months
Secondary	Changes in posttraumatic symptomatology	measured by Clinician-Administered PTSD Scale (CAPS)	2 months, 3 months and 5 months
Secondary	Changes in global functioning	measured by Functioning Assessment Short Test (FAST)	2 months, 3 months and 5 months