Clinical trial NCT03318081: The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
Official title: The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amphetamine Addiction
Keywords: Amphetamine-type stimulants
prefrontal-striatal circuits
cognitive rehabilitation therapy
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. 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);
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:

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.

Primary outcomes:
measure: Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months
timeFrame: Baseline, 1 month, 3 month and 6 months
Secondary outcomes:
measure: Cognitive function assessed by CogState Battery (CSB)
timeFrame: Baseline, 1 month, 3 month and 6 months
measure: Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)
timeFrame: Baseline, 1 month, 3 month and 6 months
measure: Number of participants who relapse
timeFrame: 1 month, 3 month and 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Compulsory Isolation Detoxification Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Zhao Min, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.