- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04993300
Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction
Repetitive Transcranial Magnetic Stimulation in Treatment of Taiwanese Amphetamine Users: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
The disease burden of methamphetamine (MA) use is a critical issue in public health, while the abusers increased rapidly in recent years. The effect of medical intervention for MA addiction is still limited, and the cost of psychotherapy is high. In Taiwan, the MA defendant would be sent to the district inspection after the police confirmed the MA abuse. The prosecutor could assess the case to replace the penalty of imprisonment with a suspended sentence, which included one year of addiction treatment in the designated hospital. However, the insufficient treatment of MA addiction resulted in a subsequent high rescinded rate of suspended sentence cases and led people to doubt these medical intervention programs. Hence, the primary mission is to improve the treatment efficacy within the treatment program. Growing evidence has suggested the effectiveness of transcranial magnetic stimulation (TMS) in improving craving, affective symptoms, and cognitive impairment. However, the majority of the studies were conducted in China. Under China's legal system, researchers designed intense TMS treatment programs for MA users, which was not entirely applicable within Taiwan's system. Therefore, the current proposal aims to design a new TMS treatment and evaluate the tolerability, efficacy, and sustained effect of Taiwanese MA users within the suspended sentence.
Methods:
The investigators applied a case-only follow-up study and divided the study into two phases. Fifteen MA users within the suspended sentence who are under the outpatient-based MA abuse treatment program will be recruited. In Phase 1, 15 subjects will be randomly assigned to two TMS intensity groups (80% and 100%). After one TMS treatment session, subjects will be interviewed with the visual analog scale and the tolerability questionnaire to detect their side-effect and the primary effect of craving reduction. After evaluating the side-effect rate and the craving reduction effect, the investigators will select the subsequent TMS treatment program's intensity. In Phase 2, all subjects undergo a four-week TMS treatment program. In Week 1, subjects will attend continuously five daily TMS sessions. In Week 2 to Week 4, subjects are treated once a week. After 8 TMS sessions, the investigators will follow up one month and three months later. The investigators apply the Visual analog scale, Beck depression inventory, Beck anxiety inventory, and Continuous performance test in each intervention and follow-up time point to measure the efficacy and sustain effect of improving craving, depression, anxiety, and cognitive impairment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chen Cheng-Che, MD, MSc
- Phone Number: 0972654912
- Email: hugocc@gmail.com
Study Locations
-
-
-
Taipei, Taiwan, 100
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Age ranged 20-65.
- Under judicially supervised outpatient-based methamphetamine abuse treatment program
Exclusion criteria:
- Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).
- Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder
- patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.
- patients who have metal implants in their bodies, as well as those with metal implants.
- people who have damaged skin in areas of the patient's body that receive stimulation.
- patients with multiple sclerosis.
- patients who have extensive ischemic scarring.
- pregnant women.
- patients with a family history of spasms/epilepsy
- patients taking medications that may lower the seizure threshold.
- patients with severe sleep disorders related to previous rTMS treatment.
- patients with severe heart disease
- patients with intracranial stress caused by uncontrollable migraines.
- people who have been evaluated by a physician as unfit to participate in clinical trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: transcranial magnetic stimulation (TMS)
This arm constitute of methamphetamine users who undergone abstinent period
|
The methamphetamine user will undergo a one-month TMS intervention.
In Week 1, subjects will attend continuously 5 daily TMS sessions.
From Week 2 to Week 4, subjects are treated once a week.
Each session will have 40 repeats of 4-second train and 15-sec train interval.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale (Taiwanese version)
Time Frame: 20 weeks
|
Respondents will specify their level of craving from none to extreme on a 100 mm line (score: 0-10) in each questionnaires, and there are nine questionnaires related to craving.
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Beck depression inventory (Taiwanese version BDI)
Time Frame: 20 weeks
|
The Beck depression inventory (Taiwanese version BDI) will be applied to evaluate the depression during the period of methamphetamine abstinence.
(Total score: 0-63)
|
20 weeks
|
The Beck anxiety inventory (Taiwanese version BAI)
Time Frame: 20 weeks
|
The Beck anxiety inventory (Taiwanese version BAI) will be applied to evaluate the anxiety during the period of methamphetamine abstinence.
(Total score: 0-63)
|
20 weeks
|
Cognitive function
Time Frame: 20 weeks
|
Continuous performance test was developed by Rosvold and designed as a computerized test of cognitive function.
|
20 weeks
|
Tolerance
Time Frame: 20 weeks
|
The respondents will specify five physical symptoms which might related to rTMS intervention (Yes/No: headache, local pain/discomfort, head/face pain/discomfort, seizure, hearing loss/ear ache)
|
20 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Chen Cheng-Che, MD,MSc, Physician, Department if Psychiatry, National Taiwan University Hospital - Biomedical Park Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202010115DINA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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