A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment

The Dynamic Network Mechanism for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Its Trans-cranial Current Stimulation

The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.

In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction.

Study Overview

• Status: Active, not recruiting
• Conditions: Methamphetamine Use Disorder
• Intervention / Treatment: Device: Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Clinical diagnosis of severe MA defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); Normal hearing and vision, or within normal range after correction;

Exclusion Criteria:

Clinical diagnosis of substance use disorder other than an MA or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5) in the past 5 years; Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria; any contraindication for fMRI scanning.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham tDCS	Device: Transcranial direct current stimulation; Participants were treated for a total of 20 sessions with active or sham stimulation at 2 mA. Each session lasted 20 min at a fixed daytime interval.
Active Comparator: real tDCS	Device: Transcranial direct current stimulation; Participants were treated for a total of 20 sessions with active or sham stimulation at 2 mA. Each session lasted 20 min at a fixed daytime interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontal lobe activation level	Balloon Analogue Risk Task during fMRI scanning (Philips Ingenia 3.0T MRI).	Two weeks
cue-induced craving	Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine ".	Two weeks,Four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Chinese version of the CogState Battery was used to assess cognitive function. We selected five tasks: Two back task (working memory), Continuous paired association task (visual spatial working memory), Groton maze learning task (error monitoring), social emotional cognition (social emotional cognition) and Detection task (processing speed) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task, social emotional cognition, and the speed in Detection task, and total errors in Continuous paired association task, Groton maze learning task are our focus.	Two weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attention bias towards methamphetamine	The Classic Clue Induced Experimental Paradigm is used to evaluate the attention bias towards drugs.	Two weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Collaborators: Wuhan Mental Health Centre; Wuhan Judicial Bureau Hanyang Compulsory Isolated Detoxification Center
• Investigators: Principal Investigator: Na Zhong, Doctor, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NZhong-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No