TDCS Combined With CT In Opioid Use Disorder

NCT ID: NCT05568251

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-01

Brief Summary

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The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) combined with cognitive training on cognitive functions in individuals with Opioid Use Disorder (OUD). The participants will be allocated into active/sham groups (1:1) and will receive a single session of prefrontal tDCS combined with cognitive training. Outcomes of the active and sham groups will be compared.

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants, investigators and outcome assessors will be blinded.

Study Groups

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Active tDCS combined with Cognitive Training

Group Type ACTIVE_COMPARATOR

transcranial Direct Current Stimulation

Intervention Type DEVICE

Participants will receive a single session of active/sham tDCS. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (right anodal/left cathodal).

Cognitive training

Intervention Type PROCEDURE

Participants will be administered Game of Dice Task concurrent with the tDCS session

Sham tDCS combined with Cognitive Training

Group Type SHAM_COMPARATOR

transcranial Direct Current Stimulation

Intervention Type DEVICE

Participants will receive a single session of active/sham tDCS. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (right anodal/left cathodal).

Cognitive training

Intervention Type PROCEDURE

Participants will be administered Game of Dice Task concurrent with the tDCS session

Interventions

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transcranial Direct Current Stimulation

Participants will receive a single session of active/sham tDCS. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (right anodal/left cathodal).

Intervention Type DEVICE

Cognitive training

Participants will be administered Game of Dice Task concurrent with the tDCS session

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Being aged between 18-65 years
* being in the maintenance phase of the OUD treatment
* naivety to tDCS
* at least 5 years of education

Exclusion Criteria

* current diagnosis of major depressive disorder
* current diagnosis or history of bipolar disorders, psychotic disorders, neurocognitive disorders, pervasive developmental disorders, mental retardation, severe neurological disorders,
* common tDCS contraindications
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)

UNKNOWN

Sponsor Role collaborator

Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Serkan Aksu

Assistant Proffessor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serkan Aksu

Role: PRINCIPAL_INVESTIGATOR

Istanbul University

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Aksu S, Soyata AZ, Seker S, Akkaya G, Yilmaz Y, Kafali T, Evren C, Umut G. Transcranial direct current stimulation combined with cognitive training improves decision making and executive functions in opioid use disorder: a triple-blind sham-controlled pilot study. J Addict Dis. 2024 Apr-Jun;42(2):154-165. doi: 10.1080/10550887.2023.2168991. Epub 2023 Mar 2.

Reference Type DERIVED
PMID: 36861945 (View on PubMed)

Other Identifiers

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2018-438

Identifier Type: -

Identifier Source: org_study_id

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