Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline Study

March 5, 2024 updated by: IrisZorg

The Feasibility and Potential Efficacy of Adding Addiction-focused EMDR to Regular Addiction Treatment A Multiple Baseline Study in Inpatients Who Use Non-opioid Drugs

Rationale: It is well established that Substance Use Disorders (SUD) have severe health consequences. Despite behavioral and pharmacological treatment options, relapse rates remain high. In particular, for non-opioid drugs, such as amphetamines, cocaine, base-coke and cannabis, established, evidence-based pharmacological options to reduce craving, to substitute substance use or to enforce abstinence are lacking. Therefore, there is a need for effective interventions for patients who use non-opioid drugs to reach and maintain long-term abstinence.

A potential interesting intervention is addiction-focused Eye Movement Desensitization and Reprocessing (AF-EMDR) therapy. However, the limited research on AF-EMDR therapy and mixed findings thus far prohibit clinical use. Recently, on the basis of diverse findings thus far, an adjusted AF-EMDR therapy protocol has been developed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: to investigate areas of uncertainty about a possible future pilot RCT using AF-EMDR as an add-on intervention in inpatients who use non-opioid drugs and receive regular, inpatient addiction treatment, by determining:

  • Feasibility.
  • Potential clinical efficacy.

Study population: adults with a primary non-opioid use disorder, who are admitted to an inpatient addiction care clinic. A total of nine eligible participants will be allocated (allocation ratio 1:1:1) at random, in a non-concurrent fashion to one of three baseline durations.

Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU.

Main study parameters/endpoints:

  • Feasibility issues.
  • Changes in daily craving.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Gelderland
      • Tiel, Gelderland, Netherlands, 4001 AG
        • Recruiting
        • Addiction clinic 'Tiel' IrisZorg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

In order to be eligible to participate in this study, patients must meet the following criteria:

Diagnosis of Tobacco Use Disorder according to the DSM-5 (American Psychiatric Association, 2013) criteria.

Age ≥ 18 years.

Good Dutch language proficiency (based on clinical judgement).

Smoking, on average, ≥ 10 cigarettes per day pre-admission.

A score of at least 5 on a scale from 0 to 10, for motivation and self-efficacy

A planned inpatient stay of ≥ 4 weeks.

Written informed consent.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

Serious therapy interfering behavior or symptoms that also interfere with TAU, based on clinical judgement (e. g. psychiatric or medical crisis that requires immediate intervention).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AF-EMDR
Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU.
Behavioral: AF-EMDR

Investigational treatment

All participants receive four 90 min. AF-EMDR sessions within a timeframe of two weeks following the baseline phase. The AF-EMDR treatment will be provided by the principal investigators, a level II EMDR therapist (RvdH) and an EMDR consultant in training who developed the AF-EMDR protocol. The EMDR therapist (RvdH) will be trained by the EMDR consultant (WM), who is available for consultation. Additionally, both participate monthly in peer-supervision whereby videotaped sessions are discussed. See appendix 1 for a detailed understanding of the AF-EMDR protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants acceptability
Time Frame: 1 year
The acceptability of AF-EMDR to participants in terms of compliance, measured by the total number of sessions attended and the proportion of attended versus non attended (planned) sessions; a higher proportion of attended sessions reflects better compliance.
1 year
Therapist acceptability
Time Frame: 1 year
The acceptability of AF-EMDR to therapists in terms of adherence to the protocol, measured by the score of an independent rater on an a-priori established adherence rating protocol; a higher score reflects better adherence. Minimum=0 ;maximum=100
1 year
Study adherence of participants
Time Frame: 1 year
from randomization until follow-up in terms of completion of tasks. A higher amount of completion means a better outcome.
1 year
Experienced (by participants) acceptability and burden
Time Frame: 1 year
The number of experienced facilitators and barriers and subjective effectiveness of the AF-EMDR intervention.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in: Subjective Units of Distress (SUD)
Time Frame: 1 year
Within and/or over AF-EMDR sessions change in: Subjective Units of Distress (SUD) (Likert-type scales), a higher score reflects a worse outcome.
1 year
Change in craving
Time Frame: 1 year
Within and/or over AF-EMDR sessions change in: Craving (Likert-type scale), a higher score reflects a worse outcome.
1 year
Change in Level of Urge (LoU)
Time Frame: 1 year
Within and/or over AF-EMDR sessions change in: Change in Level of Urge (LoU), a higher score reflects a worse outcome.
1 year
Change in: Level of Positive Affect (LoPA)
Time Frame: 1 year
Within and/or over AF-EMDR sessions change in: Level of Positive Affect (LoPA), a higher score reflects a better outcome.
1 year
changes in: Craving (MATE Q1: OCDS-5)
Time Frame: 1 year
Baseline to follow-up assessment changes in: Craving (MATE Q1: OCDS-5), a higher score reflects a worse outcome
1 year
changes in: Craving-related self-control/self-efficacy (SCCQ)
Time Frame: 1 year
Baseline to follow-up assessment changes in: Craving-related self-control/self-efficacy (SCCQ), a higher score reflects a worse outcome
1 year
changes in: Positive incentive value (SCCQ)
Time Frame: 1 year
Baseline to follow-up assessment changes in: Positive incentive value (SCCQ), a higher score reflects a worse outcome
1 year
changes in: Substance use (past 30 days) (MATE section 1)
Time Frame: 1 year
Baseline to follow-up assessment changes in: Substance use (past 30 days) (MATE section 1), a higher score reflects a worse outcome
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IrisZorg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBS AF-EMDR NODD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Use Disorders

Clinical Trials on AF-EMDR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings