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Clinical Trials/NCT05568251
NCT05568251
Completed
Not Applicable

Transcranial Direct Current Stimulation Combined With Cognitive Training In Opioid Use Disorder

Istanbul University2 sites in 1 country38 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use Disorder
Sponsor
Istanbul University
Enrollment
38
Locations
2
Primary Endpoint
Changes in the Iowa Gambling Task net score
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Serkan Aksu

Assistant Proffessor Doctor

Istanbul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in the Iowa Gambling Task net score

Time Frame: Before and immediately after the intervention

Iowa Gambling Task net score is the total score of the task (between -100 and 100) that generally assesses the decision making under ambiguity, but also assesses the decision making under risk at the later stages. Higher scores in the task represents better decision making and healthy people generally have scores above 8-10 in the task.

Changes in the Adjusted Number of Pumps in the Balloon Analogue Risk Task

Time Frame: Before and immediately after the intervention

The Balloon Analogue Risk Task is the commonly used computerized measure of decision making under risk. Main outcome variable of the task is the Adjusted Number of Pumps which includes the mean number of pumps in the trials that not resulted with an explosion. Lower values mean lower impulsivity.

Secondary Outcomes

  • Changes in Interference Time in the Stroop Test(Before and immediately after the intervention)
  • Changes in the Stop Signal Reaction time in the Stop Signal Test(Before and immediately after the intervention)
  • Changes in the digit span performance(Before and immediately after the intervention)
  • Changes in the Trail Making Test A Time(Before and immediately after the intervention)
  • Changes in the Trail Making Test B Time(Before and immediately after the intervention)
  • Changes in the verbal fluency performance(Before and immediately after the intervention)
  • Changes in the Letter Number Sequencing (LNS) Test performance(Before and immediately after the intervention)

Study Sites (2)

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