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

• Sponsor: Shanghai Mental Health Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04139148
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Methamphetamine-dependence; Transcranial Direct Current Stimulation; Computerized Cognitive AddictionTherapy; Electronic Health Records	Device: Ture Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change from Baseline cue-induced craving at 2 weeks [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. Change from Baseline cue-induced craving at 4 weeks [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".

Secondary Outcome Measures

1. Attention bias towards methamphetamine [2 weeks，4 weeks]

   A Chinese version of the MA addiction dot probe task (DPT) is used to evaluate the attention bias towards drugs.

2. cognitive function [2 weeks，4 weeks]

   Chinese version of the CogState Battery was used to assess cognitive function.

3. response inhibition function [2 weeks，4 weeks]

   stop signal task

4. reward-related function [2 weeks，4 weeks]

   Delay Discounting Task

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Mental Health Center	Shanghai		China

Sponsors and Collaborators

• Shanghai Mental Health Center

Investigators

• Principal Investigator: Na Zhong, doctor, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Mental Health Center
• ClinicalTrials.gov Identifier: NCT04139148
• Other Study ID Numbers: NZhong-002
• First Posted: Oct 25, 2019
• Last Update Posted: Nov 18, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 18, 2019