Drug AddictionNCT06888700
Project on tDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals
A study testing Transcranial direct current stimulation in people with Drug Addiction, run by Shaanxi Normal University at 1 site in China.
Trial summary
This project aims to explore key brain functional and biochemical indicators associated with impaired advanced social cognition through an integrated approach encompassing unconscious control, conscious control, cognitive flexibility, problem-solving, and social interaction domains. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 17 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 30 and 60 years;
- fulfilling the diagnostic criteria for severe substance use disorder as specified in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders.
- a history of heroin use exceeding ten years, with a daily average intake of at least 0.1 grams.
- abstinence duration of eight months or less, with a positive result of a urine test before entering the rehabilitation center.
- no history of neuromodulation treatments such as tDCS within the past six months.
Who cannot join
- a history of alcohol dependence, neurological disorders, or other complex psychiatric conditions.
- the presence of intracranial metallic implants or elevated intracranial pressure.
- a history of epilepsy or recent electroencephalogram evidence of epileptiform activity.
- the use of implanted electronic devices, such as pacemakers;.
- scalp hyperalgesia or a tendency toward bleeding.
- severe cardiac conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center
Xi'an, Shaanxi, 710062
About this study
This project aims to explore key brain functional and biochemical indicators associated with impaired advanced social cognition through an integrated approach encompassing unconscious control, conscious control, cognitive flexibility, problem-solving, and social interaction domains. By incorporating multimodal measures spanning physiological, neural, cognitive, psychological, and behavioral dimensions, we will develop a comprehensive intervention protocol combining course-based brain stimulation and cognitive training. The study will employ a multi-timepoint, multi-level assessment framework to track the enhancement of higher cognitive functions and brain functional recovery in individuals undergoing drug rehabilitation.
- Conditions
- Drug Addiction
- Being tested
- Transcranial direct current stimulation
- Keywords
- heroin, advanced social cognitive function
- Medical subject headings
- Substance-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
The participant cohort recruited for this study consists of individuals with substance use disorder (SUD), specifically those addicted to drugs. During the intervention phase, this group will adhere to a strict non-pharmacological intervention protocol, meaning they will not receive any form of pharmacotherapy, neurosurgical intervention, or other neuromodulation-based cognitive interventions, including but not limited to techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). This design aims to ensure the internal validity of the study results and to exclude potential confounding effects of other interventions on neuroplasticity and cognitive function.
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | The study was sham-controlled, randomized, and double-blind. Participants with HUD were randomly assigned to either the active or sham groups. The DC-STIMULATOR PLUS (neuroConn, Germany) was used to deliver stimulation via saline-soaked sponge electrodes (25 cm², 5×5 cm, 1.5 mA). The anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region. The stimulation in the active group lasted for 20 min with a 30-s fade-in and a 30-s fade-out. They received five stimulation sessions within one week, with a minimum interval of 24 hours between each session. The tDCS sensitivity questionnaire was used to assess blinding validity. Receives: Device: Transcranial direct current stimulation |
| Sham group | Sham comparator | The study was sham-controlled, randomized, and double-blind. Participants with HUD were randomly assigned to either the active or sham groups. The DC-STIMULATOR PLUS (neuroConn, Germany) was used to deliver stimulation via saline-soaked sponge electrodes (25 cm², 5×5 cm, 1.5 mA). The anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region.The stimulation in the sham group was set up as a stimulation cycle of 30s fade-in and 30s fade-out, followed by no current stimulation. They received five stimulation sessions within one week, with a minimum interval of 24 hours between each session. The tDCS sensitivity questionnaire was used to assess blinding validity. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical activation from fNIRS
Measured: From enrollment to the end of treatment at 1 month
Cortical functional connectivity from fNIRS
Measured: From enrollment to the end of treatment at 1 month
Inter-brain neural synchronization from fNIRS hyperscaning
Measured: From enrollment to the end of treatment at 1 month
EEG power
Measured: From enrollment to the end of treatment at 1 month
EEG microstate
Measured: From enrollment to the end of treatment at 1 month
Functional connectivity from EEG
Measured: From enrollment to the end of treatment at 1 month
Realistic presented problem task score
Used to measure problem-solving ability
Measured: From enrollment to the end of treatment at 1 month
Score on the Group Realistic Problem Solving task
Used to measure collaborative problem-solving ability
Measured: From enrollment to the end of treatment at 1 month
Score on the joint drawing task
Used to measure interactive collaboration.
Measured: From enrollment to the end of treatment at 1 month
Scores on the pattern game task
Used to measure social cooperation and competition
Measured: From enrollment to the end of treatment at 1 month
Secondary outcomes (8)
Pupil response from eye-tracking
Measured: From enrollment to the end of treatment at 1 month
Average fixation duration from eye-traking
Measured: From enrollment to the end of treatment at 1 month
Fixation time percentage from eye-traking
Measured: From enrollment to the end of treatment at 1 month
Alternative use task (AUT) score
Used to measure problem-solving ability
Measured: From enrollment to the end of treatment at 1 month
Score on the Group Alternative Use Task
Used to measure collaborative problem solving ability
Measured: From enrollment to the end of treatment at 1 month
Cognitive flexibility
Assessed by Wisconsin Card Quest (WCST).
Measured: From enrollment to the end of treatment at 1 month
Cognitive inhibition
Assessed by stroop task
Measured: From enrollment to the end of treatment at 1 month
Mind wandering
Assessed by interpolation task
Measured: From enrollment to the end of treatment at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start19 Mar 2025 (estimated)
- Primary completion18 Apr 2025 (estimated)
- Study completion17 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Normal University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Principal investigator, Yifan Wang, Shaanxi Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888700
- Sponsor's protocol ID
- L20240186
- Other IDs
- SFBJYJZXM2023-21-06, 32471114
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a government-collaborative project involving sensitive personal information of a vulnerable population, and as such, it is imperative to adhere to strict confidentiality protocols. All data collected will be handled in compliance with ethical guidelines and legal requirements to ensure the protection of participants' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project on tDCS Intervention to Enhance Advanced Social Cognitive Functions in Drug Rehabilitation Individuals
- ClinicalTrials.gov ID
- NCT06888700
- Acronym / sponsor ID
- L20240186
- Conditions
- Drug Addiction
- Keywords
- heroin, advanced social cognitive function
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Shaanxi Normal UniversityUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 19 Mar 2025 (estimated)
- Primary completion
- 18 Apr 2025 (estimated)
- Study completion
- 17 Nov 2028 (estimated)
- First posted
- 21 Mar 2025 (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.
This project aims to explore key brain functional and biochemical indicators associated with impaired advanced social cognition through an integrated approach encompassing unconscious control, conscious control, cognitive flexibility, problem-solving, and social interaction domains. By incorporating multimodal measures spanning physiological, neural, cognitive, psychological, and behavioral dimensions, we will develop a comprehensive intervention protocol combining course-based brain stimulation and cognitive training. The study will employ a multi-timepoint, multi-level assessment framework to track the enhancement of higher cognitive functions and brain functional recovery in individuals undergoing drug rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: Transcranial direct current stimulationThe study was sham-controlled, randomized, and double-blind. Participants with HUD were randomly assigned to either the active or sham groups. The DC-STIMULATOR PLUS (neuroConn, Germany) was used to deliver stimulation via saline-soaked sponge electrodes (25 cm², 5×5 cm, 1.5 mA). The anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region. The stimulation in the active group lasted for 20 min with a 30-s fade-in and a 30-s fade-out. They received five stimulation sessions within one week, with a minimum interval of 24 hours between each session. The tDCS sensitivity questionnaire was used to assess blinding validity. |
| Sham group | Sham comparator | Device: Transcranial direct current stimulationThe study was sham-controlled, randomized, and double-blind. Participants with HUD were randomly assigned to either the active or sham groups. The DC-STIMULATOR PLUS (neuroConn, Germany) was used to deliver stimulation via saline-soaked sponge electrodes (25 cm², 5×5 cm, 1.5 mA). The anode was positioned over the rTPJ (P6), with the cathode placed on the left sub-occipital region.The stimulation in the sham group was set up as a stimulation cycle of 30s fade-in and 30s fade-out, followed by no current stimulation. They received five stimulation sessions within one week, with a minimum interval of 24 hours between each session. The tDCS sensitivity questionnaire was used to assess blinding validity. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 30 and 60 years;
- fulfilling the diagnostic criteria for severe substance use disorder as specified in the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders.
- a history of heroin use exceeding ten years, with a daily average intake of at least 0.1 grams.
- abstinence duration of eight months or less, with a positive result of a urine test before entering the rehabilitation center.
- no history of neuromodulation treatments such as tDCS within the past six months.
Key exclusion criteria (6 listed)
- a history of alcohol dependence, neurological disorders, or other complex psychiatric conditions.
- the presence of intracranial metallic implants or elevated intracranial pressure.
- a history of epilepsy or recent electroencephalogram evidence of epileptiform activity.
- the use of implanted electronic devices, such as pacemakers;.
- scalp hyperalgesia or a tendency toward bleeding.
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 stimulationThe participant cohort recruited for this study consists of individuals with substance use disorder (SUD), specifically those addicted to drugs. During the intervention phase, this group will adhere to a strict non-pharmacological intervention protocol, meaning they will not receive any form of pharmacotherapy, neurosurgical intervention, or other neuromodulation-based cognitive interventions, including but not limited to techniques such as transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). This design aims to ensure the internal validity of the study results and to exclude potential confounding effects of other interventions on neuroplasticity and cognitive function. | Device | Active group, Sham group |
Primary outcome
Cortical activation from fNIRS
Time frame: From enrollment to the end of treatment at 1 month
Cortical functional connectivity from fNIRS
Time frame: From enrollment to the end of treatment at 1 month
Inter-brain neural synchronization from fNIRS hyperscaning
Time frame: From enrollment to the end of treatment at 1 month
EEG power
Time frame: From enrollment to the end of treatment at 1 month
EEG microstate
Time frame: From enrollment to the end of treatment at 1 month
Functional connectivity from EEG
Time frame: From enrollment to the end of treatment at 1 month
Realistic presented problem task score
Time frame: From enrollment to the end of treatment at 1 month
Used to measure problem-solving ability
Score on the Group Realistic Problem Solving task
Time frame: From enrollment to the end of treatment at 1 month
Used to measure collaborative problem-solving ability
Score on the joint drawing task
Time frame: From enrollment to the end of treatment at 1 month
Used to measure interactive collaboration.
Scores on the pattern game task
Time frame: From enrollment to the end of treatment at 1 month
Used to measure social cooperation and competition
8 secondary outcomes
Pupil response from eye-tracking
Time frame: From enrollment to the end of treatment at 1 month
Average fixation duration from eye-traking
Time frame: From enrollment to the end of treatment at 1 month
Fixation time percentage from eye-traking
Time frame: From enrollment to the end of treatment at 1 month
Alternative use task (AUT) score
Time frame: From enrollment to the end of treatment at 1 month
Score on the Group Alternative Use Task
Time frame: From enrollment to the end of treatment at 1 month
Cognitive flexibility
Time frame: From enrollment to the end of treatment at 1 month
Cognitive inhibition
Time frame: From enrollment to the end of treatment at 1 month
Mind wandering
Time frame: From enrollment to the end of treatment at 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No. This study is a government-collaborative project involving sensitive personal information of a vulnerable population, and as such, it is imperative to adhere to strict confidentiality protocols. All data collected will be handled in compliance with ethical guidelines and legal requirements to ensure the protection of participants' privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Drug Addiction, run by Shaanxi Normal University at 1 site in China.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cortical activation from fNIRS (time frame: From enrollment to the end of treatment at 1 month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2025.