Clinical trial NCT06917534: The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction
Official title: The Cognitive Neural Mechanisms and Neuroregulatory Interventions of Realistic Creative Problem-solving Under the Effects of Drug Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Addiction
Keywords: heroin
creative problem solving
divergent thinking
group problem solving
Lead sponsor: Shaanxi Normal University
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2025-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Score on the Realistic Presented Problem Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Group Realistic Problem Solving Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Cortical activation from fNIRS
timeFrame: From enrollment to the end of treatment at 1 month
measure: Cortical functional connectivity from fNIRS
timeFrame: From enrollment to the end of treatment at 1 month
measure: Inter-brain neural synchronization from fNIRS hyperscaning
timeFrame: From enrollment to the end of treatment at 1 month
measure: Pupil response from eye-tracking
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Alternative Use Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Group Alternative Use Task
timeFrame: From enrollment to the end of treatment at 1 month
Secondary outcomes:
measure: Average fixation duration from eye-traking
timeFrame: From enrollment to the end of treatment at 1 month
measure: Fixation time percentage from eye-traking
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the joint drawing task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Chain Free Association Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Verbal Fluency Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Divergent Association Task
timeFrame: From enrollment to the end of treatment at 1 month
measure: Score on the Wsiconsin Card Sorting Test (WCST)
timeFrame: From enrollment to the end of treatment at 1 month
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Provincial Chang'an Compulsory Isolation Drug Rehabilitation Center
state: Shaanxi
Study officials:
References: