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Clinical Trials/NCT04139148
NCT04139148UnknownNot Applicable

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

Shanghai Mental Health Center1 site in 1 country100 target enrollmentStarted: February 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Change from Baseline cue-induced craving at 2 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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).

Arms & Interventions

True tDCS Combined With CCAT

Active Comparator

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.

Intervention: Ture Transcranial Direct Current Stimulation (tDCS) (Device)

Sham tDCS Combined With CCAT

Sham Comparator

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.

Intervention: Sham Transcranial Direct Current Stimulation (tDCS) (Device)

Control group

No Intervention

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.

Outcomes

Primary Outcomes

Change from Baseline cue-induced craving at 2 weeks

Time Frame: 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".

Change from Baseline cue-induced craving at 4 weeks

Time Frame: 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 Outcomes

  • response inhibition function(2 weeks,4 weeks)
  • cognitive function(2 weeks,4 weeks)
  • Attention bias towards methamphetamine(2 weeks,4 weeks)
  • reward-related function(2 weeks,4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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