NCT04993300

Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 However, the insufficient treatment of MA addiction resulted in a subsequent high rescinded rate of suspended sentence cases and led people to doubt these medical intervention programs.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

Conditions

• Craving
• Depression, Anxiety
• Amphetamine Addiction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-17
• Primary completion: 2022-08-04
• Completion: 2022-08-04
• First posted: 2021-08-06
• Last updated: 2023-03-30

Locations

1 site across 1 country: Taiwan