Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction

Depression, Anxiety Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation in Treatment of Taiwanese Amphetamine Users: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993300
• Other study ID #: 202010115DINA
• Status: Completed
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: August 4, 2022

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to test whether transcranial magnetic stimulation (TMS) improves the craving, depression, anxiety and cognitive function during the abstinent period of methamphetamine users.

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 However, the insufficient treatment of MA addiction resulted in a subsequent high rescinded rate of suspended sentence cases and led people to doubt these medical intervention programs.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion criteria:

1. Age ranged 20-65.

2. Under judicially supervised outpatient-based methamphetamine abuse treatment program

Exclusion criteria:

1. Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).

2. Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder

3. patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.

4. patients who have metal implants in their bodies, as well as those with metal implants.

5. people who have damaged skin in areas of the patient's body that receive stimulation.

6. patients with multiple sclerosis.

7. patients who have extensive ischemic scarring.

8. pregnant women.

9. patients with a family history of spasms/epilepsy

10. patients taking medications that may lower the seizure threshold.

11. patients with severe sleep disorders related to previous rTMS treatment.

12. patients with severe heart disease

13. patients with intracranial stress caused by uncontrollable migraines.

14. people who have been evaluated by a physician as unfit to participate in clinical trials.

Related Conditions & MeSH terms

• Amphetamine Addiction
• Amphetamine-Related Disorders
• Behavior, Addictive
• Craving
• Depression, Anxiety

Intervention

Device:
• transcranial magnetic stimulation (TMS)
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue scale (Taiwanese version)	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	The Beck depression inventory (Taiwanese version BDI)	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
Secondary	The Beck anxiety inventory (Taiwanese version BAI)	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
Secondary	Cognitive function	Continuous performance test was developed by Rosvold and designed as a computerized test of cognitive function.	20 weeks
Secondary	Tolerance	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