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

NCT ID: NCT05923697

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-12-31

Brief 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. 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.

Conditions

Substance Use Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AF-EMDR

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

Group Type: EXPERIMENTAL

AF-EMDR

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

IrisZorg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Addiction clinic 'Tiel' IrisZorg

Tiel, Gelderland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Reinier van den Haak

Role: CONTACT

r.haak@iriszorg.nl

088 - 606 1152

Wiebren Markus

Role: CONTACT

w.markus@iriszorg.nl

088 - 606 1396

Facility Contacts

Reinier van den Haak, MSc

Role: primary

r.haak@iriszorg.nl

Other Identifiers

MBS AF-EMDR NODD

Identifier Type: -

Identifier Source: org_study_id