Clinical trial NCT05535101: Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder
Official title: Exploration of Non-invasive Theta Burst Stimulation in Patients With Methamphetamine Use Disorder: Efficacy and Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craving
Depression, Anxiety
Amphetamine Addiction
Keywords: Addiction
amphetamine
non-invasive theta burst stimulation
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2022-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to apply the intermittent theta burst transcranial magnetic stimulation (iTBS) treatment and evaluate the effect in improving craving, affective symptoms, and cognitive function for those participants in the community with amphetamine use. An electroencephalography and blood biomarkers will also be examined to explore the possible mechanisms.

Detailed description: In this study, participants with amphetamine use will be recruited from psychiatric clinics. They will be randomly assigned to two different transcranial magnetic stimulation groups, the iTBS and sham groups. Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes, and 5 high-frequency iTBS sessions per week in total four weeks. After the completion of the four-week course, the severity of symptoms for the next one month and three months will be tracked.

Eligibility criteria: Inclusion Criteria:

1. Age ranged 20-65.
2. Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V

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 with metal implants above the chest.
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: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Secondary outcomes:
measure: The Beck depression inventory (Taiwanese version BDI)
timeFrame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
measure: The Beck anxiety inventory (Taiwanese version BAI)
timeFrame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
measure: Cognitive function
timeFrame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
measure: Tolerance
timeFrame: Post intervention everytime (8 times total)
measure: blood biomarkers
timeFrame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
measure: Electroencephalography
timeFrame: Baseline(Week 0), Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch
name: Cheng-Che Chen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: