Substance Use DisordersNCT05923697
Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline Study
A study testing AF-EMDR in people with Substance Use Disorders, run by IrisZorg at 1 site in Netherlands.
Trial summary
Rationale: It is well established that Substance Use Disorders (SUD) have severe health consequences. Despite behavioral and pharmacological treatment options, relapse rates remain high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- AF-EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Nov 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Addiction clinic 'Tiel' IrisZorg
Tiel, Gelderland, 4001 AG
Reinier van den Haak, MSc, r.haak@iriszorg.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- AF-EMDR
- Keywords
- Addiction, EMDR, Non-opioid drug disorder
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF-EMDRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AF-EMDR | Experimental | Intervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU. Receives: Behavioral: AF-EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants acceptability
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.
Measured: 1 year
Therapist acceptability
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
Measured: 1 year
Study adherence of participants
from randomization until follow-up in terms of completion of tasks. A higher amount of completion means a better outcome.
Measured: 1 year
Experienced (by participants) acceptability and burden
The number of experienced facilitators and barriers and subjective effectiveness of the AF-EMDR intervention.
Measured: 1 year
Secondary outcomes (8)
Change in: Subjective Units of Distress (SUD)
Within and/or over AF-EMDR sessions change in: Subjective Units of Distress (SUD) (Likert-type scales), a higher score reflects a worse outcome.
Measured: 1 year
Change in craving
Within and/or over AF-EMDR sessions change in: Craving (Likert-type scale), a higher score reflects a worse outcome.
Measured: 1 year
Change in Level of Urge (LoU)
Within and/or over AF-EMDR sessions change in: Change in Level of Urge (LoU), a higher score reflects a worse outcome.
Measured: 1 year
Change in: Level of Positive Affect (LoPA)
Within and/or over AF-EMDR sessions change in: Level of Positive Affect (LoPA), a higher score reflects a better outcome.
Measured: 1 year
changes in: Craving (MATE Q1: OCDS-5)
Baseline to follow-up assessment changes in: Craving (MATE Q1: OCDS-5), a higher score reflects a worse outcome
Measured: 1 year
changes in: Craving-related self-control/self-efficacy (SCCQ)
Baseline to follow-up assessment changes in: Craving-related self-control/self-efficacy (SCCQ), a higher score reflects a worse outcome
Measured: 1 year
changes in: Positive incentive value (SCCQ)
Baseline to follow-up assessment changes in: Positive incentive value (SCCQ), a higher score reflects a worse outcome
Measured: 1 year
changes in: Substance use (past 30 days) (MATE section 1)
Baseline to follow-up assessment changes in: Substance use (past 30 days) (MATE section 1), a higher score reflects a worse outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start6 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Study design: a non-concurrent multiple baseline design is used in which participants are allocated at random to a baseline period of 7, 10, or 13 days after which they proceed to an intervention phase of two weeks in which they receive four 90 min. sessions of AF-EMDR and a follow-up interview after one month. During both the baseline and the AF-EMDR intervention phase, participants also receive Treatment As Usual (TAU: Community Reinforcement Approach (CRA)), aimed at SUD.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IrisZorg
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923697
- Sponsor's protocol ID
- MBS AF-EMDR NODD
- Status last verified
- Mar 2024
- First submitted
- 13 Jun 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05923697
- Acronym / sponsor ID
- MBS AF-EMDR NODD
- Conditions
- Substance Use Disorders
- Keywords
- Addiction, EMDR, Non-opioid drug disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- IrisZorgUniversity, hospital or other
- Collaborators
- Radboud University Medical Center
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Jun 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study design: a non-concurrent multiple baseline design is used in which participants are allocated at random to a baseline period of 7, 10, or 13 days after which they proceed to an intervention phase of two weeks in which they receive four 90 min. sessions of AF-EMDR and a follow-up interview after one month. During both the baseline and the AF-EMDR intervention phase, participants also receive Treatment As Usual (TAU: Community Reinforcement Approach (CRA)), aimed at SUD.
| Arm | Type | Receives |
|---|---|---|
| AF-EMDR | Experimental | Behavioral: AF-EMDRIntervention: a total of four 90 min. sessions of AF-EMDR twice per week added to TAU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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 |
|---|---|---|
| AF-EMDRInvestigational 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. | Behavioural | AF-EMDR |
Primary outcome
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.
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
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.
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.
8 secondary outcomes
Change in: Subjective Units of Distress (SUD)
Time frame: 1 year
Change in craving
Time frame: 1 year
Change in Level of Urge (LoU)
Time frame: 1 year
Change in: Level of Positive Affect (LoPA)
Time frame: 1 year
changes in: Craving (MATE Q1: OCDS-5)
Time frame: 1 year
changes in: Craving-related self-control/self-efficacy (SCCQ)
Time frame: 1 year
changes in: Positive incentive value (SCCQ)
Time frame: 1 year
changes in: Substance use (past 30 days) (MATE section 1)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided. Depending on the final data collection and the journal in which these are published, we will decide on availability of IPD
Related trials for Substance Use Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF-EMDR in people with Substance Use Disorders, run by IrisZorg at 1 site in Netherlands.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reinier van den Haak (088 - 606 1152, r.haak@iriszorg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants acceptability (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.