Clinical trial NCT03827785: Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence
Official title: The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine-dependence
Keywords: repetitive transcranial magnetic stimulation (rTMS)
randomized clinical trials
treatment
craving
cognitive function
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Wuxi Mental Health Center, Jiangsu Provence, China
name: Suzhou Guangji Hospital, Jiangsu Provence, China
name: Wuhan Mental Health Center, Hubei Provence, China
name: Yunnan Institute For Drug Abuse
First posted: 2019-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Negative rate urine test
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of Craving assessed by Visual Analog Scale
timeFrame: 12 weeks
measure: Cognitive function assessed by CogState Battery (CSB)
timeFrame: 12 weeks
measure: Depression status assessed by Hamilton depression scale (HAMD-17)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Rehabilitation Center
Study officials:
affiliation: Shanghai Mental Health Center
name: Haifeng Jiang
role: PRINCIPAL_INVESTIGATOR
References: