NCT03318081

Brief Summary

The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type stimulant (ATS) addiction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

October 15, 2017

Last Update Submit

January 8, 2020

Conditions

Amphetamine Addiction

Keywords

Amphetamine-type stimulantsprefrontal-striatal circuitscognitive rehabilitation therapy

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months

    evaluate all participants' craving for ATS by Visual Analog Scales (VAS): The scores of the VAS were 0-10 points. 10 points reflect the highest level of individual's craving, and 0 point reflect no craving in patient.

    Baseline, 1 month, 3 month and 6 months

Secondary Outcomes (3)

  • Cognitive function assessed by CogState Battery (CSB)

    Baseline, 1 month, 3 month and 6 months

  • Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)

    Baseline, 1 month, 3 month and 6 months

  • Number of participants who relapse

    1 month, 3 month and 6 months

Study Arms (3)

cognitive function rehabilitation group

ACTIVE COMPARATOR

The main content of cognitive function rehabilitation esecutive function,including working memory,sustained attention, response inhibition function and cognitive flexibility, 45 minutes a day over 6 weeks period.

Behavioral: cognitive function rehabilitation and bias modification

cognitive bias modification group

ACTIVE COMPARATOR

The main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period.

Behavioral: cognitive function rehabilitation and bias modification

control group

NO INTERVENTION

Participants only accept the regular scheduled in the compulsory isolated detoxification center

Interventions

cognitive function rehabilitation and bias modificationBEHAVIORAL

cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias

cognitive bias modification groupcognitive function rehabilitation group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed MA dependence in accordance with the fourth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (Association, 2000);
  • more than 9 years of education;
  • aged of 18-60 years old;
  • normal vision, audition and no color blindness;
  • receive no detoxification medications during treatment and
  • right handedness.

You may not qualify if:

  • current medical diseases that required hospitalization or regular monitoring;
  • serious physical or neurological illness that required pharmacological treatment affecting cognitive function;
  • history of major psychiatric disorder such as bipolar disorder, schizophrenia, depression and disorders of high comorbidity with substance abuse/dependence;
  • neurological diseases such as stroke, seizure, migraine, head trauma
  • substance dependence other than nicotine, within the past 5 years;
  • intelligence quotient (IQ) \<70.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Compulsory Isolation Detoxification Center

Shanghai, China

Location

Related Publications (1)

  • Zhu Y, Jiang H, Su H, Zhong N, Li R, Li X, Chen T, Tan H, Du J, Xu D, Yan H, Xu D, Zhao M. A Newly Designed Mobile-Based Computerized Cognitive Addiction Therapy App for the Improvement of Cognition Impairments and Risk Decision Making in Methamphetamine Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e10292. doi: 10.2196/10292.

    PMID: 29925497DERIVED

MeSH Terms

Conditions

Amphetamine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Zhao Min, PhD, MD

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 23, 2017

Study Start

October 20, 2017

Primary Completion

December 31, 2017

Study Completion

May 1, 2018

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)