Clinical trial NCT04993300: Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction
Official title: Repetitive Transcranial Magnetic Stimulation in Treatment of Taiwanese Amphetamine Users: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craving
Depression, Anxiety
Amphetamine Addiction
Keywords: Addiction
amphetamine
transcranial magnetic stimulation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2021-08-06
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 However, the insufficient treatment of MA addiction resulted in a subsequent high rescinded rate of suspended sentence cases and led people to doubt these medical intervention programs.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

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale (Taiwanese version)
timeFrame: 20 weeks
Secondary outcomes:
measure: The Beck depression inventory (Taiwanese version BDI)
timeFrame: 20 weeks
measure: The Beck anxiety inventory (Taiwanese version BAI)
timeFrame: 20 weeks
measure: Cognitive function
timeFrame: 20 weeks
measure: Tolerance
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Physician, Department if Psychiatry, National Taiwan University Hospital - Biomedical Park Hospital
name: Chen Cheng-Che, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: