Drug AddictionNCT06917534
The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction
A study testing Transcranial direct current stimulation in people with Drug Addiction, run by Yifan Wang at 1 site in China.
Trial summary
Drug addiction persists as a significant global social concern with a negative impact on social harmony and stability that cannot be ignored. After returning to society, individuals with drug addiction often suffer from impaired creative problem-solving abilities and difficulties in interpersonal cooperation. 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 15 Aug 2024
- 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 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.
China1 site
Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center
Xi'an, Shaanxi, 710062
About this study
Drug addiction persists as a significant global social concern with a negative impact on social harmony and stability that cannot be ignored. After returning to society, individuals with drug addiction often suffer from impaired creative problem-solving abilities and difficulties in interpersonal cooperation. The difficulties in survival stress and the sense of helplessness triggered by these factors are important reasons that lead them to seek drugs repeatedly and even to commit criminal behaviors. Therefore, enhancing creative realistic problem-solving abilities emerges as a pivotal pathway for drug addicts to facilitate rehabilitation from drug addiction and achieve societal adaptation. The project emphasizes both individual and collaborative creative solution generation for realistic problem solving. The abnormal cognitive neural mechanisms and interpersonal neural mechanisms will be systematically explored by using multiple cognitive and neuroimaging methods, such as functional near-infrared spectroscopy (fNIRS), electroencephalography (EEG), and eye-tracking. From the cognitive-behavioral-brain level, a comprehensive neurophysiological multimodal predictive model of how drug addiction affects creative realistic problem-solving will be constructed by multi-level data fitting modeling. Building upon this research foundation, The investigators will further implement single and repeated sessions of transcranial direct current stimulation (tDCS) targeting damaged brain regions for the intervention of individual and collaborative problem-solving ability under the effect of drug addiction. The indicators of brain, cognition, and behavior will be tracked at multiple time points.
- Conditions
- Drug Addiction
- Being tested
- Transcranial direct current stimulation
- Keywords
- heroin, creative problem solving, divergent thinking, group problem solving
- 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 drug addiction 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 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 | Arm Description: 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 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.
Score on the Realistic Presented Problem Task
Used to measure problem-solving ability individual creative problem-solving
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
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
Pupil response from eye-tracking
Measured: From enrollment to the end of treatment at 1 month
Score on the Alternative Use Task
Used to measure the individual 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
Measured: From enrollment to the end of treatment at 1 month
Secondary outcomes (7)
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
Score on the joint drawing task
Used to measure collaborative problem-solving from the perspective of social interaction.
Measured: From enrollment to the end of treatment at 1 month
Score on the Chain Free Association Task
Used to measure remote associative ability.
Measured: From enrollment to the end of treatment at 1 month
Score on the Verbal Fluency Task
Used to measure remote association ability
Measured: From enrollment to the end of treatment at 1 month
Score on the Divergent Association Task
used to measure the divergent Association ability
Measured: From enrollment to the end of treatment at 1 month
Score on the Wsiconsin Card Sorting Test (WCST)
Used to measure cognitive flexibility.
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 posted8 Apr 2025
- Study start23 Nov 2023
- Primary completion18 May 2024
- Study completion15 Aug 2024
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yifan Wang
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor-investigator, Yifan Wang, Shaanxi Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917534
- Sponsor's protocol ID
- L20230122
- Other IDs
- 32471114
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 8 Apr 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction
- ClinicalTrials.gov ID
- NCT06917534
- Acronym / sponsor ID
- L20230122
- Conditions
- Drug Addiction
- Keywords
- heroin, creative problem solving, divergent thinking, group problem solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yifan WangUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 18 May 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 8 Apr 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.
Drug addiction persists as a significant global social concern with a negative impact on social harmony and stability that cannot be ignored. After returning to society, individuals with drug addiction often suffer from impaired creative problem-solving abilities and difficulties in interpersonal cooperation. The difficulties in survival stress and the sense of helplessness triggered by these factors are important reasons that lead them to seek drugs repeatedly and even to commit criminal behaviors. Therefore, enhancing creative realistic problem-solving abilities emerges as a pivotal pathway for drug addicts to facilitate rehabilitation from drug addiction and achieve societal adaptation. The project emphasizes both individual and collaborative creative solution generation for realistic problem solving. The abnormal cognitive neural mechanisms and interpersonal neural mechanisms will be systematically explored by using multiple cognitive and neuroimaging methods, such as functional near-infrared spectroscopy (fNIRS), electroencephalography (EEG), and eye-tracking. From the cognitive-behavioral-brain level, a comprehensive neurophysiological multimodal predictive model of how drug addiction affects creative realistic problem-solving will be constructed by multi-level data fitting modeling. Building upon this research foundation, The investigators will further implement single and repeated sessions of transcranial direct current stimulation (tDCS) targeting damaged brain regions for the intervention of individual and collaborative problem-solving ability under the effect of drug addiction. The indicators of brain, cognition, and behavior will be tracked at multiple time points.
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 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 stimulationArm Description: 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 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 drug addiction 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
Score on the Realistic Presented Problem Task
Time frame: From enrollment to the end of treatment at 1 month
Used to measure problem-solving ability individual creative problem-solving
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
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
Pupil response from eye-tracking
Time frame: From enrollment to the end of treatment at 1 month
Score on the Alternative Use Task
Time frame: From enrollment to the end of treatment at 1 month
Used to measure the individual problem-solving ability
Score on the Group Alternative Use Task
Time frame: From enrollment to the end of treatment at 1 month
Used to measure collaborative problem-solving
7 secondary outcomes
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
Score on the joint drawing task
Time frame: From enrollment to the end of treatment at 1 month
Score on the Chain Free Association Task
Time frame: From enrollment to the end of treatment at 1 month
Score on the Verbal Fluency Task
Time frame: From enrollment to the end of treatment at 1 month
Score on the Divergent Association Task
Time frame: From enrollment to the end of treatment at 1 month
Score on the Wsiconsin Card Sorting Test (WCST)
Time frame: From enrollment to the end of treatment at 1 month
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 8 Apr 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. This study is not recruiting at the moment.
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 Yifan Wang 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: finished, as of the sponsor's last update on 8 Apr 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?
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?
Score on the Realistic Presented Problem Task (time frame: From enrollment to the end of treatment at 1 month). The study lists 8 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 8 Apr 2025.