Clinical trial NCT05923697: Addiction-focused EMDR in Inpatients Who Use Non-opioid Drugs: a Multiple Baseline 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Keywords: Addiction
EMDR
Non-opioid drug disorder
Lead sponsor: IrisZorg
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
First posted: 2023-06-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Participants acceptability
timeFrame: 1 year
measure: Therapist acceptability
timeFrame: 1 year
measure: Study adherence of participants
timeFrame: 1 year
measure: Experienced (by participants) acceptability and burden
timeFrame: 1 year
Secondary outcomes:
measure: Change in: Subjective Units of Distress (SUD)
timeFrame: 1 year
measure: Change in craving
timeFrame: 1 year
measure: Change in Level of Urge (LoU)
timeFrame: 1 year
measure: Change in: Level of Positive Affect (LoPA)
timeFrame: 1 year
measure: changes in: Craving (MATE Q1: OCDS-5)
timeFrame: 1 year
measure: changes in: Craving-related self-control/self-efficacy (SCCQ)
timeFrame: 1 year
measure: changes in: Positive incentive value (SCCQ)
timeFrame: 1 year
measure: changes in: Substance use (past 30 days) (MATE section 1)
timeFrame: 1 year
Other outcomes:
Locations:
city: Tiel
country: Netherlands
facility: Addiction clinic 'Tiel' IrisZorg
state: Gelderland
Study officials:
References: