The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Negative rate urine test
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- •Junior high school degree or above
- •Normal vision and hearing
- •Dextromanual
- •Less than one month before last drug use
Exclusion Criteria
- •Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
- •Have cognitive-promoting drugs in the last 6 months
- •Other substance abuse or dependence in recent five years (except nicotine)
- •Mental impairment, Intelligence Quotient (IQ) < 70
- •Mental disorders
- •Physical disease
Outcomes
Primary Outcomes
Negative rate urine test
Time Frame: 12 weeks
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.
Secondary Outcomes
- Cognitive function assessed by CogState Battery (CSB)(12 weeks)
- Change of Craving assessed by Visual Analog Scale(12 weeks)
- Depression status assessed by Hamilton depression scale (HAMD-17)(12 weeks)