Transcranial Direct Current Stimulation (tDCS) Combined With Computerized Cognitive Addiction Therapy(CCAT) and, Electronic Follow-up for Methamphetamine(MA) Dependent Patients

Study Overview
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Brief Summary
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Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Electronic medical systems were applied for drug related knowledge education, self-evaluation and outpatient follow-up reminder after intervention in order to reduce relapse behaviors.

Official Title
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Study on the Effectiveness of Treatment Regulation Mode Based on Neuromodulation and Electronic Follow-up to Reduce Relapse Behavior in Patients With Substance Dependence

Conditions
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Methamphetamine-dependence, Transcranial Direct Current Stimulation, Computerized Cognitive AddictionTherapy, Electronic Health Records

Intervention / Treatment
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* Device: Ture Transcranial Direct Current Stimulation (tDCS)
* Device: Sham Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Methamphetamine dependent patients with normal eyesight and hearing. Exclusion Criteria: any diagnosis of DSM-IV axis I diseases. any physical diseases which might influence cognitive function such as epilepsy, cerebrovascular disease or brain injury. negative behaviors or harm to others. cognitive enhance drug use history in last 6 months. other drug dependence(except nicotine).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: True tDCS Combined With CCAT<br>Ture transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including drug knowledge every week, self-evaluation every two weeks and outpatient follow-up reminder every four weeks. | Device: Ture Transcranial Direct Current Stimulation (tDCS)<br>* Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm).<br>|
| Sham Comparator: Sham tDCS Combined With CCAT<br>Sham transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including only outpatient follow-up reminder every four weeks. | Device: Sham Transcranial Direct Current Stimulation (tDCS)<br>* Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm).<br>|
| No Intervention: Control group<br>During the treatment, the participants in control group only received treatment such as education of psychology, health and judicature, physical training as well as vocational training as usual in the compulsory rehabilitation center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline cue-induced craving at 2 weeks | Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being no cravingand 100 mm representing most craving ever experienced for methamphetamine. | 2 weeks | 
| Change from Baseline cue-induced craving at 4 weeks | Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being no cravingand 100 mm representing most craving ever experienced for methamphetamine. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention bias towards methamphetamine | A Chinese version of the MA addiction dot probe task (DPT) is used to evaluate the attention bias towards drugs. | 2 weeks，4 weeks | 
| cognitive function | Chinese version of the CogState Battery was used to assess cognitive function. | 2 weeks，4 weeks | 
| response inhibition function | stop signal task | 2 weeks，4 weeks | 
| reward-related function | Delay Discounting Task | 2 weeks，4 weeks |