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Completed

NCT Number: NCT03318081

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

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

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Key information

Conditions

Amphetamine Addiction Amphetamine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Compulsory Isolation Detoxification Center

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

cognitive function rehabilitation and bias modification

Behavioral

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

Primary outcomes

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

    Time frame: Baseline, 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.

Secondary outcomes

  1. Cognitive function assessed by CogState Battery (CSB)

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

    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.

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

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

    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.

  3. Number of participants who relapse

    Time frame: 1 month, 3 month and 6 months

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

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 23, 2017
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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