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

NCT06279273 | Unknown

• 1 other identifier: NZhong-005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Methamphetamine Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Cognitive function

  Two weeks

Other Outcomes (1)

• Attention bias towards methamphetamine

  Two weeks

Study Arms (2)

real tDCS

ACTIVE COMPARATOR

Device: Transcranial direct current stimulation

sham tDCS

SHAM COMPARATOR

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

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.

real tDCS; sham tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Wuhan Mental Health Centre: collaborator
• Wuhan Judicial Bureau Hanyang Compulsory Isolated Detoxification Center: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Na Zhong, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-01

Locations

CN (1)