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

Transcranial Direct Current Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139148
• Other study ID #: NZhong-002
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2019
• Source: Shanghai Mental Health Center
• Contact: Na Zhong, Doctor, doctor
• Phone: 008613671644472
• Email: winco917[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Device:
• Ture Transcranial Direct Current Stimulation (tDCS)
Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm).
• Sham Transcranial Direct Current Stimulation (tDCS)
Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm).

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 craving"and 100 mm representing "most craving ever experienced for methamphetamine".	2 weeks
Primary	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 craving"and 100 mm representing "most craving ever experienced for methamphetamine".	4 weeks
Secondary	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
Secondary	cognitive function	Chinese version of the CogState Battery was used to assess cognitive function.	2 weeks,4 weeks
Secondary	response inhibition function	stop signal task	2 weeks,4 weeks
Secondary	reward-related function	Delay Discounting Task	2 weeks,4 weeks