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CompletedNCT03318081Updated Jan 13, 2020

The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction

An interventional study of cognitive function rehabilitation and bias modification in Amphetamine Addiction, sponsored by Shanghai Mental Health Center. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

The deficits in executive functions related to prefrontal-striatal circuits play a vital role in ATS addiction and relapse, and proposed computerized cognitive rehabilitation therapy as the novel interventions. Focused on evaluating and training executive functions including working memory, inhibitory control, cognitive flexibility, and congitive bias concerning prefrontal-striatal circuits, neuropsychological tests, electroencephalography tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to evaluate the therapeutic effect of ATS addiction treatment as well as investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.

02

Conditions studied

  • Amphetamine Addiction

Keywords

  • Amphetamine-type stimulants
  • prefrontal-striatal circuits
  • cognitive rehabilitation therapy
03

In context

Amphetamine-Related Disorders

61 studies on the registry are indexed under Amphetamine-Related Disorders; 4 are open to participants now.

This study's enrollment of 40 is close to the median of 44 across 54 interventional studies indexed under Amphetamine-Related Disorders.

Browse Amphetamine-Related Disorders studies →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.

Browse Shanghai Mental Health Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. diagnosed MA dependence in accordance with the fourth edition of the American Psychiatric Association's (DSM-IV) (Association, 2000);
  2. more than 9 years of education;
  3. aged of 18-60 years old;
  4. normal vision, audition and no color blindness;
  5. receive no detoxification medications during treatment and
  6. right handedness.

Exclusion criteria

Exclusion Criteria:

  1. current medical diseases that required hospitalization or regular monitoring;
  2. serious physical or neurological illness that required pharmacological treatment affecting cognitive function;
  3. history of major psychiatric disorder such as bipolar disorder, schizophrenia, depression and disorders of high comorbidity with substance abuse/dependence;
  4. neurological diseases such as stroke, seizure, migraine, head trauma
  5. substance dependence other than nicotine, within the past 5 years;
  6. intelligence quotient (IQ) \<70.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    cognitive function rehabilitation group

    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

  • Active comparator
    cognitive bias modification group

    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

  • No intervention
    control group

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

Interventions

  • Behavioralcognitive function rehabilitation and bias modification

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

06

What researchers measure

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.

    Time frame: Baseline, 1 month, 3 month and 6 months

Secondary outcomes

  1. Cognitive function assessed by CogState Battery (CSB)

    evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version: The five tasks listed below were examined. International shopping list task (ISLT, verbal learning and memory), the score is defined as the total number of correct responses. Continuous paired association learning task (CPAL) taps spatial working memory. Groton maze learning task (GML) taps problem solving/error monitoring. The scores of CPAL and GML tasks are the total number of errors. Social emotional cognition task (SEC, social cognition) asks the subjects to pick out the different facial expressions. Two back task (TWOB, working memory) requires subjects to decide whether a card is identical to the one shown just before. The scores of TWOB and SEC tasks are the proportion of correct responses, denoting the accuracy of performance. The higher values represent a better outcome in ISL, SEC and TWOB. The higher values represent a worse outcome in GML and CPAL.

    Time frame: Baseline, 1 month, 3 month and 6 months

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

    evaluate all participants' response inhibition function by Balloon Analogue Risk Task (BART): Several indices were computed to represent the behavioral performance, including the ratio of all pumps to numbers of win trials, the ratio of pumps to numbers in win trials, and the number of win trials. The higher values represent a worse outcome.

    Time frame: Baseline, 1 month, 3 month and 6 months

  3. Number of participants who relapse

    Follow up with patients after discharge, evaluate number of participants who relapse. The higher values represent a worse outcome.

    Time frame: 1 month, 3 month and 6 months

07

Study locations

1 site
  • Shanghai Compulsory Isolation Detoxification Center
    Shanghai, China
08

References and documents

Publications

  • 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. PubMed 29925497 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Dec 2017, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2017
First posted
Oct 23, 2017
StartActual
Oct 20, 2017
Primary completionActual
Dec 31, 2017
CompletionActual
May 1, 2018
Last update
Jan 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03318081
Lead sponsor
Shanghai Mental Health Center
Responsible party
Sponsor
First posted
Oct 23, 2017
Start date
Oct 20, 2017
Primary completion
Dec 31, 2017
Completion
May 1, 2018
Last update
Jan 13, 2020

Study contacts

Zhao Min, PhD, MD
principal investigator · Shanghai Mental Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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