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Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence

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ClinicalTrials.gov Identifier: NCT03827785
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Wuxi Mental Health Center, Jiangsu Provence, China
Suzhou Guangji Hospital, Jiangsu Provence, China
Wuhan Mental Health Center, Hubei Provence, China
Yunnan Institute For Drug Abuse
Information provided by (Responsible Party):
Shanghai Mental Health Center

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.

Condition or disease Intervention/treatment Phase
Methamphetamine-dependence Device: rTMS treatment group Device: sham rTMS treatment group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : December 12, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
Experimental: rTMS treatment group
Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days.
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 Comparator: sham rTMS treatment group
Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days.
Device: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change of Craving assessed by Visual Analog Scale [ Time Frame: 12 weeks ]
    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.

  2. Cognitive function assessed by CogState Battery (CSB) [ Time Frame: 12 weeks ]
    evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version

  3. Depression status assessed by Hamilton depression scale (HAMD-17) [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827785


Contacts
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Contact: Haifeng Jiang 021-64906315 dragonjhf@hotmail.com

Locations
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China
Shanghai Rehabilitation Center Recruiting
Shanghai, China, 200010
Contact: Daqing Shi         
Sponsors and Collaborators
Shanghai Mental Health Center
Wuxi Mental Health Center, Jiangsu Provence, China
Suzhou Guangji Hospital, Jiangsu Provence, China
Wuhan Mental Health Center, Hubei Provence, China
Yunnan Institute For Drug Abuse
Investigators
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Principal Investigator: Haifeng Jiang Shanghai Mental Health Center
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03827785    
Other Study ID Numbers: HFJiang-002
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Mental Health Center:
repetitive transcranial magnetic stimulation (rTMS)
randomized clinical trials
treatment
craving
cognitive function