Robot-Assisted Intelligent Rehabilitation Treatment for Methamphetamine Use Disorders.

Amphetamine Addiction Clinical Trial

Official title:

Randomized Clinical Trial of Robot-Assisted Intelligent Rehabilitation Treatment in Comparison With Standard Treatment for Methamphetamine Use Disorders and Alcohol Use Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531384
• Other study ID #: MZhao-010
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Shanghai Mental Health Center
• Contact: Min Zhao
• Phone: 64387250
• Email: drminzhao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to evaluate the efficacy and safety of Robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (MA) use disorders.

Description:

Based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available Robot-assisted rehabilitation intelligent system. Then, using this intelligent system as a new way of Psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of Robot-assisted rehabilitation intelligent system in Chinese methamphetamine patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders;
• Education level equal or more than 9 years;
• Have normal or corrected-to-normal vision;
• Have normal or corrected-to-normal hearing;
• Less than 3 months before last drug use;

Exclusion Criteria:

• Current substance use (except nicotine or caffeine);
• History of disease which influence cognition,such as seizure disorder?cerebrovascular disease?head injury or other severe medication conditions;
• Intelligence quotient less than 70.

Related Conditions & MeSH terms

• Amphetamine Addiction
• Amphetamine-Related Disorders

Intervention

Device:
• robot-assisted rehabilitation intelligent treatment
robot-assisted rehabilitation psychotherapy

Other:
• standard psychotherapy treatment
standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions

Locations

Country	Name	City	State
China	Shanghai Gaojing Rehabilitation Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of galvanic skin response during the virtual reality based addiction assessment system	The galvanic skin response is an emotional physiological indicator, and its unit is ohm.	in 1 year
Secondary	Treatment motivation	Using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) to measure the treatment motivation of the participants. The score of the scale is between 19 and 95. The higher the score, the higher the treatment motivation.	in 1 year
Secondary	Anxiety	Anxiety is assessed by the State-Trait Anxiety Scale (SAS). The score of the SAS scale is between 0 and 80. The higher the score, the more severe the anxiety symptoms.	in 1 year
Secondary	Depression	Depression is assessed by the the Beck Depression Scale (SDS). The score of the SDS scale is between 0 and 80. The higher the score, the more severe the depression symptoms.	in 1 year
Secondary	Attentional bias related to drugs and emotional stimulation	The emotional Stroop tests is used for assessed attentional bias. The indicator is the accuracy rate of the key presses, from 0 to 100%.	in 1 year
Secondary	Risky decision-making	Balloon Analogue Risk Task is used for assess the risky decision-making ability. The indicator is the average number of balloon blows, and its unit is times.	in 1 year
Secondary	Reaction inhibition ability	Stop signal task is used for assess the reaction inhibition ability. The indicator is the reaction time when the participant completes the task, and its unit is milliseconds.	in 1 year
Secondary	Changes of electroencephalogram power spectrum during the virtual reality based addiction	The electroencephalogram power spectrum reflects the functional status of the brain, and its unit is uV^2.	in 1 year