TDCS Combined With CT In Opioid Use Disorder (OpiStim)

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

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 Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Device: transcranial Direct Current Stimulation; Procedure: Cognitive training

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University
  • Istanbul, Turkey
    • Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS combined with Cognitive Training	Device: 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).; Procedure: Cognitive training; Participants will be administered Game of Dice Task concurrent with the tDCS session
Sham Comparator: Sham tDCS combined with Cognitive Training	Device: 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).; Procedure: Cognitive training; Participants will be administered Game of Dice Task concurrent with the tDCS session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Interference Time in the Stroop Test	The stroop effect (Interference Time) consists of both the semantic and the response conflict. Response conflict (time in milliseconds) is obtained by subtracting the semantic conflict (time in milliseconds obtained in the second step of the protocol) from the stroop effect (time in milliseconds obtained in the first step of the protocol). Minimum time difference is 0 and maximum time difference is 100 milliseconds. Lower time differences indicate better performance and higher time differences indicate worse performance.	Before and immediately after the intervention
Changes in the Stop Signal Reaction time in the Stop Signal Test	The Stop-Signal Task (SST) is a task requiring inhibition of a prepotent motor response. The SST requires participants to respond to a target stimulus as quickly and accurately as possible by pressing a button, but also to withhold their response when they hear an auditory signal. Thus, this task involves a competition between activating and inhibiting processes. The primary outcome variable is change in the stop signal reaction time (SSRT) for the task administered seconds to minutes before and seconds to minutes after stimulation. The theoretical minimum is zero seconds and there is no theoretical maximum. Higher SSRT scores reflect greater impulsivity.	Before and immediately after the intervention
Changes in the verbal fluency performance	Verbal fluency is a test that measure multiple domains of cognition such as executive functions and language functions. Phonemic Fluency assesses the number of words beginning with certain letters that participants can generate within 60 seconds, the semantic Fluency assesses the number of words within particular categories participants can generate within 60 seconds. Alternating fluency assesses the number of fruit-name pairs reported in a minute duration. Theoretical minimum is zero and there is no theoretical maximum . Lower scores indicate worse performance and higher scores indicate better performance.	Before and immediately after the intervention
Changes in the digit span performance	The Digit Span test is a measure of verbal short-term/working memory. Subjects must recall all digits either in forward (digit span forward) or backward (digit span backward) order. Digit span forward total score: 0-10; higher score indicate better performance, digit span backwards total score: 0-10; higher score indicate better performance	Before and immediately after the intervention
Changes in the Trail Making Test A Time	Trail Making A Test is a widely used as a quick and easy to administer measure of attention. Lower reaction times indicate better performance and higher reaction times indicate worse performance. Minimum time is 10 milliseconds and maximum time is 150 milliseconds.	Before and immediately after the intervention
Changes in the Trail Making Test B Time	Trail Making B Test is a widely used as a quick and easy to administer measure of executive functions. Lower reaction times indicate better performance and higher reaction times indicate worse performance. Minimum time is 10 milliseconds and maximum time is 150 milliseconds.	Before and immediately after the intervention
Changes in the Letter Number Sequencing (LNS) Test performance	Letter number is a test of working memory which involves ordering a series of up to 8 letters and numbers in which the numbers are repeated back first in order starting with the lowest number, then followed by the letters in alphabetical order. LNS consists of 10 items and each item has 3 trials rated as Incorrect (0) or Correct (1). The LNS total raw score (range 0 to 30) is auto-calculated by summing the 10 individual item scores (range 0 to 3 for each item). Higher number of correct items correlated to better performance and a negative change from baseline indicates worsening.	Before and immediately after the intervention

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
• Investigators: Principal Investigator: Serkan Aksu, Istanbul University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; opioid use disorder; brain stimulation; cognitive functions; neuropsychological evaluation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders
• Other Study ID Numbers: 2018-438

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No