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

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

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.

Study Overview

• Status: Unknown
• Conditions: Methamphetamine-dependence; Transcranial Direct Current Stimulation; Electronic Health Records; Computerized Cognitive AddictionTherapy
• Intervention / Treatment: Device: Ture Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Mental Health Center
    • Contact: Na Zhong, doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: True tDCS Combined With CCAT; 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); Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm).
Sham Comparator: Sham tDCS Combined With CCAT; 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); Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm).
No Intervention: Control group; 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?

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 craving"and 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 craving"and 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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Na Zhong, Doctor, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NZhong-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No