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TDCS Combined With CT In Opioid Use Disorder (OpiStim)

Primary Purpose

Opioid Use Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation
Cognitive training
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring brain stimulation, cognitive functions, neuropsychological evaluation, opioid use disorder, transcranial direct current stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS combined with Cognitive Training

Sham tDCS combined with Cognitive Training

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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.
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.
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.

Full Information

First Posted
October 1, 2022
Last Updated
October 4, 2022
Sponsor
Istanbul University
Collaborators
Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
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1. Study Identification

Unique Protocol Identification Number
NCT05568251
Brief Title
TDCS Combined With CT In Opioid Use Disorder
Acronym
OpiStim
Official Title
Transcranial Direct Current Stimulation Combined With Cognitive Training In Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
brain stimulation, cognitive functions, neuropsychological evaluation, opioid use disorder, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants, investigators and outcome assessors will be blinded.
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS combined with Cognitive Training
Arm Type
Active Comparator
Arm Title
Sham tDCS combined with Cognitive Training
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation
Intervention Description
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
Procedure
Intervention Name(s)
Cognitive training
Intervention Description
Participants will be administered Game of Dice Task concurrent with the tDCS session
Primary Outcome Measure Information:
Title
Changes in the Iowa Gambling Task net score
Description
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.
Time Frame
Before and immediately after the intervention
Title
Changes in the Adjusted Number of Pumps in the Balloon Analogue Risk Task
Description
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.
Time Frame
Before and immediately after the intervention
Secondary Outcome Measure Information:
Title
Changes in Interference Time in the Stroop Test
Description
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.
Time Frame
Before and immediately after the intervention
Title
Changes in the Stop Signal Reaction time in the Stop Signal Test
Description
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.
Time Frame
Before and immediately after the intervention
Title
Changes in the verbal fluency performance
Description
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.
Time Frame
Before and immediately after the intervention
Title
Changes in the digit span performance
Description
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
Time Frame
Before and immediately after the intervention
Title
Changes in the Trail Making Test A Time
Description
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.
Time Frame
Before and immediately after the intervention
Title
Changes in the Trail Making Test B Time
Description
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.
Time Frame
Before and immediately after the intervention
Title
Changes in the Letter Number Sequencing (LNS) Test performance
Description
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.
Time Frame
Before and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan Aksu
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University
City
Istanbul
Country
Turkey
Facility Name
Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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TDCS Combined With CT In Opioid Use Disorder

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