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Clinical Trials/NCT06454474
NCT06454474CompletedNot Applicable

Individualized Neuromodulation Intervention Techniques for the Core Clinical Features of Drug Addiction

Shanghai Mental Health Center3 sites in 1 country21 target enrollmentStarted: June 30, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
3
Primary Endpoint
Visual Analog Scale for craving (VAS-Craving)

Study Overview

Brief Summary

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes the effect of closed-loop tACS based on brain states

Detailed Description

Methamphetamine use disorder (MUD) addiction represents a severe public health concern. Individuals addicted to methamphetamine exhibit intense cravings and physiological reactions when exposed to addiction-related cues, a phenomenon termed "cue reactivity." Cue reactivity is a critical factor in the development and persistence of addiction. Impairments in inhibitory control are considered a significant factor contributing to the emergence of cue reactivity. Conventional pharmacological and physical interventions suffer from low efficiency and high effect variance. Closed-loop physical interventions, which adjust stimulation parameters in real-time based on brain state, are an innovative approach with the potential to enhance the precision and efficiency of treatments. Closed-loop interventions based on transcranial alternating current stimulation (tACS) hold promise as a novel therapeutic method for treating methamphetamine addiction. This study aims to develop and evaluate the effect of closed-loop tACS on cue reactivity and inhibition control function in MUD. Therefore, the investigators intend to employ the non-invasive tACS technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education or are capable of effectively cooperating in questionnaire evaluations.
  • •Meet the diagnostic criteria set forth by the DSM-5 concerning the severity of amphetamine-type substance addiction.
  • •A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use of at least once per week.
  • •Consent to actively cooperate in the completion of subsequent follow-up assessments.

Exclusion Criteria

  • •Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than
  • •A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
  • •Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
  • •Severe organic diseases that might compromise study participation. Contraindications to tACS, include a history of epileptic seizures or the presence of metallic implants in proximity to the head.

Arms & Interventions

Closed-loop tACS stimulation based on addiction-induced states

Experimental

In the initial phase of this study, participants will receive individualized closed-loop tACS interventions once daily for five consecutive days. Concurrently, they will be exposed to MA-related cue paradigms to induce cue-reactivity states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues.

Intervention: Closed-loop tACS stimulation based on addiction-induced states (Device)

Outcomes

Primary Outcomes

Visual Analog Scale for craving (VAS-Craving)

Time Frame: through study completion, an average of 5 days

The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale for craving (VAS-Craving), where individuals rated their cravings on a scale from 0 to 100, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.

Secondary Outcomes

  • Obsessive Compulsive Drug Use Scale (OCDUS)(through study completion, an average of 5 days)
  • Stop-signal task(through study completion, an average of 5 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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