Substance Use DisordersNCT05488691
Eye Movement Desensitization and Reprocessing as a Treatment for Substance Use Disorders
A study testing EMDR and TAU in people with Substance Use Disorders, run by Hospital Clinic of Barcelona at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- EMDR and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Long-term exposure to corticoids.
- Claustrophobia.
- Subjects with pacemakers.
- Presence of metallic objects within the body.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What Works and Why? Eye Movement Desensitization and Reprocessing as a Potential 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.
- Conditions
- Substance Use Disorders
- Being tested
- EMDR, TAU
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
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.
TAUBehavioural
treatment as usual for substance use disorders
| Study group | Role | What they receive |
|---|---|---|
| Eye Movement Desensitization and Reprocessing therapy | Experimental | 8 to 10 individual 60-minutes sessions over 2 months. Receives: Behavioral: EMDR; Behavioral: TAU |
| Treatment as usual | Active comparator | Same periodicity as the experimental group and at the same time range. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months
Secondary outcomes (10)
changes in functional connectivity
measured by resting-state fMRI
Measured: 2 months
percentage of conditioned eyeblink responses (CR)
measured by the Eyeblink Conditioning System
Measured: 2 months
CR latency, CR onset, and CR amplitude.
measured by the Eyeblink Conditioning System
Measured: 2 months
Hair and salivary cortisol levels
Comparison of the Area Under the Curve pre and post treatment
Measured: 2 months
Craving
Self-report measurement
Measured: 2 months 3 months and 5 months
Total amount of substance consumed during the previous month
measured by the TLFB
Measured: 2 months, 3 months and 5 months
Changes in depressive symptomatology
measured by Beck's Depression Inventory (BDI)
Measured: 2 months, 3 months and 5 months
Changes in anxious symptomatology
measured by The State-Trait Anxiety Inventory (STAI)
Measured: 2 months, 3 months and 5 months
Changes in posttraumatic symptomatology
measured by Clinician-Administered PTSD Scale (CAPS)
Measured: 2 months, 3 months and 5 months
Changes in global functioning
measured by Functioning Assessment Short Test (FAST)
Measured: 2 months, 3 months and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Feb 2022
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo López-Pelayo, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488691
- Sponsor's protocol ID
- PI20/00506
- Status last verified
- Sep 2025
- First submitted
- 2 Jun 2022
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40792354
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Works and Why? Eye Movement Desensitization and Reprocessing as a Potential Treatment for Substance Use Disorders
- ClinicalTrials.gov ID
- NCT05488691
- Acronym / sponsor ID
- PI20/00506
- Conditions
- Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye Movement Desensitization and Reprocessing therapy | Experimental | Behavioral: EMDR, Behavioral: TAU8 to 10 individual 60-minutes sessions over 2 months. |
| Treatment as usual | Active comparator | Behavioral: TAUSame periodicity as the experimental group and at the same time range. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDRThe 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. | Behavioural | Eye Movement Desensitization and Reprocessing therapy |
| TAUtreatment as usual for substance use disorders | Behavioural | Eye Movement Desensitization and Reprocessing therapy, Treatment as usual |
Primary outcome
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)
10 secondary outcomes
changes in functional connectivity
Time frame: 2 months
percentage of conditioned eyeblink responses (CR)
Time frame: 2 months
CR latency, CR onset, and CR amplitude.
Time frame: 2 months
Hair and salivary cortisol levels
Time frame: 2 months
Craving
Time frame: 2 months 3 months and 5 months
Total amount of substance consumed during the previous month
Time frame: 2 months, 3 months and 5 months
Changes in depressive symptomatology
Time frame: 2 months, 3 months and 5 months
Changes in anxious symptomatology
Time frame: 2 months, 3 months and 5 months
Changes in posttraumatic symptomatology
Time frame: 2 months, 3 months and 5 months
Changes in global functioning
Time frame: 2 months, 3 months and 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 40792354Sanchez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR and TAU in people with Substance Use Disorders, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 16 Sep 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to relapse (time frame: 2 months). 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 NCT05488691, which also lists 1 linked publication.
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 16 Sep 2025.