Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence

Methamphetamine-dependence Clinical Trial

Official title:

The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827785
• Other study ID #: HFJiang-002
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 12, 2020

Study information

• Verified date: September 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA) addiction in previous studies, while the evidence-based protocols still required. The aim of this research is to evaluating the effectiveness and safety of rTMS treatment in improving the days of abstinence maintenance. In addition, treatment effect on cognitive impairment, psychological craving and depression are also evaluated during the study.

Description:

First, a multicenter, double-blind, randomized control study is going to be carried out. 100 recruited patients will be randomized assigned to the intervention group and the control group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test follow-up (1 time per week). Negative rate of urine test during the follow-up period is set as primary outcome. Cognitive function, craving, depression are also evaluated before and after the intervention.

Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of relapse for both the patients and their families.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 12, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders

2. Junior high school degree or above

3. Normal vision and hearing

4. Dextromanual

5. Less than one month before last drug use

Exclusion Criteria:

1. Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc

2. Have cognitive-promoting drugs in the last 6 months

3. Other substance abuse or dependence in recent five years (except nicotine)

4. Mental impairment, Intelligence Quotient (IQ) < 70

5. Mental disorders

6. Physical disease

Related Conditions & MeSH terms

• Methamphetamine-dependence

Intervention

Device:
• rTMS treatment group
For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.
• sham rTMS treatment group
For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.

Locations

Country	Name	City	State
China	Shanghai Rehabilitation Center	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Suzhou Guangji Hospital, Jiangsu Provence, China, Wuhan Mental Health Center, Hubei Provence, China, Wuxi Mental Health Center, Jiangsu Provence, China, Yunnan Institute For Drug Abuse

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative rate urine test	After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive.; Negative rate of urine drug test = actual number of negative urine tests / 12.	12 weeks
Secondary	Change of Craving assessed by Visual Analog Scale	evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.	12 weeks
Secondary	Cognitive function assessed by CogState Battery (CSB)	evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version	12 weeks
Secondary	Depression status assessed by Hamilton depression scale (HAMD-17)	Evaluate all participants' depression status by Hamilton depression scale (HAMD-17) HAMD can be summarized into 7 types of factor structure: (1) anxiety/somatization:; (2) weight: weight loss (3) Cognitive obstacles; (4) day and night changes; (5) Block; (6) sleep disorder; (7) feeling of despair. The total score can reflect the severity of the symptom, that is, The lighter the symptoms, the lower the score, and vice versa. Mild depression: HAMD 17 scores > 7 points, = 17 points; moderate depression: HAMD 17 scores > 17 points, = 24 points; severe depression: HAMD 17 scores > 24 points.	12 weeks