Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction
Condition: Craving; Depression, Anxiety; Amphetamine Addiction
MeSH terms: Amphetamine-Related Disorders; Behavior, Addictive
Study type: Interventional

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      the insufficient treatment of MA addiction resulted in a subsequent high rescinded rate of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.
    

Intervention name(s): transcranial magnetic stimulation (TMS)
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Addiction; amphetamine; transcranial magnetic stimulation