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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06279273
Enrollment
60
Registered
2024-02-28
Start date
2023-01-01
Completion date
2025-12-31
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Use Disorder

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.

Interventions

DEVICETranscranial 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.

Sponsors

Wuhan Mental Health Centre
CollaboratorOTHER
Wuhan Judicial Bureau Hanyang Compulsory Isolated Detoxification Center
CollaboratorUNKNOWN
Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Frontal lobe activation levelTwo weeksBalloon Analogue Risk Task during fMRI scanning (Philips Ingenia 3.0T MRI).
cue-induced cravingTwo weeks,Four weeksCraving was assessed by visual analog scales (VAS), with 0 mm being no cravingand 100 mm representing most craving ever experienced for methamphetamine .

Secondary

MeasureTime frameDescription
Cognitive functionTwo weeksChinese 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.

Other

MeasureTime frameDescription
Attention bias towards methamphetamineTwo weeksThe Classic Clue Induced Experimental Paradigm is used to evaluate the attention bias towards drugs.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026