Opioid Use DisorderOpiStimNCT05568251
TDCS Combined With CT In Opioid Use Disorder
A study testing transcranial Direct Current Stimulation and Cognitive training in people with Opioid Use Disorder, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- transcranial Direct Current Stimulation and Cognitive training
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being aged between 18-65 years
- being in the maintenance phase of the OUD treatment
- naivety to tDCS
- at least 5 years of education
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University
Istanbul
Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
Istanbul
About this study
Official title: 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.
- Conditions
- Opioid Use Disorder
- Keywords
- brain stimulation, cognitive functions, neuropsychological evaluation, opioid use disorder, transcranial direct current stimulation
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current StimulationDevice
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).
Cognitive trainingProcedure or surgery
Participants will be administered Game of Dice Task concurrent with the tDCS session
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS combined with Cognitive Training | Active comparator | Not described Receives: Device: transcranial Direct Current Stimulation; Procedure: Cognitive training |
| Sham tDCS combined with Cognitive Training | Sham comparator | Not described Receives: Device: transcranial Direct Current Stimulation; Procedure: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before and immediately after the intervention
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
- Responsible party
- Principal investigator, Serkan Aksu, Istanbul University
- Investigators
- Serkan Aksu, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568251
- Sponsor's protocol ID
- 2018-438
- Acronym
- OpiStim
- Status last verified
- Oct 2022
- First submitted
- 1 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36861945
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Combined With Cognitive Training In Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05568251
- Acronym / sponsor ID
- OpiStim / 2018-438
- Conditions
- Opioid Use Disorder
- Keywords
- brain stimulation, cognitive functions, neuropsychological evaluation, opioid use disorder, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS combined with Cognitive Training | Active comparator | Device: transcranial Direct Current Stimulation, Procedure: Cognitive training |
| Sham tDCS combined with Cognitive Training | Sham comparator | Device: transcranial Direct Current Stimulation, Procedure: Cognitive training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being aged between 18-65 years
- being in the maintenance phase of the OUD treatment
- naivety to tDCS
- at least 5 years of education
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial Direct Current StimulationParticipants 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). | Device | Active tDCS combined with Cognitive Training, Sham tDCS combined with Cognitive Training |
| Cognitive trainingParticipants will be administered Game of Dice Task concurrent with the tDCS session | Procedure or surgery | Active tDCS combined with Cognitive Training, Sham tDCS combined with Cognitive Training |
Primary outcome
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.
7 secondary outcomes
Changes in Interference Time in the Stroop Test
Time frame: Before and immediately after the intervention
Changes in the Stop Signal Reaction time in the Stop Signal Test
Time frame: Before and immediately after the intervention
Changes in the verbal fluency performance
Time frame: Before and immediately after the intervention
Changes in the digit span performance
Time frame: Before and immediately after the intervention
Changes in the Trail Making Test A Time
Time frame: Before and immediately after the intervention
Changes in the Trail Making Test B Time
Time frame: Before and immediately after the intervention
Changes in the Letter Number Sequencing (LNS) Test performance
Time frame: Before and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Derived from this study: PubMed 36861945Aksu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Aksu principal investigator
Istanbul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation and Cognitive training in people with Opioid Use Disorder, run by Istanbul University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Iowa Gambling Task net score (time frame: Before and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.