Transcranial Direct Current Stimulation Combined With Cognitive Training In Opioid Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 38
- Locations
- 4
- Primary Endpoint
- Changes in the Iowa Gambling Task net score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Participants, investigators and outcome assessors will be blinded.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Serkan Aksu
Assistant Proffessor Doctor
Istanbul University