Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence

Shanghai Mental Health Center

Status: Completed

Conditions: Methamphetamine-dependence

Treatments: Device: sham rTMS treatment group; Device: rTMS treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT03827785

HFJiang-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

rTMS treatment group

Experimental group

Description:

Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days.

Treatment:

Device: rTMS treatment group

sham rTMS treatment group

Sham Comparator group

Description:

Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days.

Treatment:

Device: sham rTMS treatment group