TDCS Combined With CT In Opioid Use Disorder
OpiStim
Transcranial Direct Current Stimulation Combined With Cognitive Training In Opioid Use Disorder
1 other identifier
interventional
38
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedOctober 6, 2022
October 1, 2022
1 year
October 1, 2022
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in the Iowa Gambling Task net score
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.
Before and immediately after the intervention
Changes in the Adjusted Number of Pumps in the Balloon Analogue Risk Task
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.
Before and immediately after the intervention
Secondary Outcomes (7)
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 verbal fluency performance
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
- +2 more secondary outcomes
Study Arms (2)
Active tDCS combined with Cognitive Training
ACTIVE COMPARATORSham tDCS combined with Cognitive Training
SHAM COMPARATORInterventions
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).
Participants will be administered Game of Dice Task concurrent with the tDCS session
Eligibility Criteria
You may qualify if:
- Being aged between 18-65 years
- being in the maintenance phase of the OUD treatment
- naivety to tDCS
- at least 5 years of education
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istanbul University
Istanbul, Turkey (Türkiye)
Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 36861945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Serkan Aksu
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants, investigators and outcome assessors will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Proffessor Doctor
Study Record Dates
First Submitted
October 1, 2022
First Posted
October 5, 2022
Study Start
June 1, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
October 6, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share