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

Substance Use Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923697
• Other study ID #: MBS AF-EMDR NODD
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: IrisZorg
• Contact: Reinier van den Haak
• Phone: 088 - 606 1152
• Email: r.haak[@]iriszorg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Behavior, Addictive
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Addiction clinic 'Tiel' IrisZorg	Tiel	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
IrisZorg	Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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	1 year
Primary	Study adherence of participants	from randomization until follow-up in terms of completion of tasks. A higher amount of completion means a better outcome.	1 year
Primary	Experienced (by participants) acceptability and burden	The number of experienced facilitators and barriers and subjective effectiveness of the AF-EMDR intervention.	1 year
Secondary	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.	1 year
Secondary	Change in craving	Within and/or over AF-EMDR sessions change in: Craving (Likert-type scale), a higher score reflects a worse outcome.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	changes in: Positive incentive value (SCCQ)	Baseline to follow-up assessment changes in: Positive incentive value (SCCQ), a higher score reflects a worse outcome	1 year
Secondary	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	1 year