CravingNCT05535101
Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder
A study testing Intermittent theta burst transcranial magnetic stimulation (iTBS) in people with Craving and Depression, Anxiety, run by National Taiwan University Hospital Hsin-Chu Branch.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Craving, Depression, Anxiety, Amphetamine Addiction
- What is being tested?
- Intermittent theta burst transcranial magnetic stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranged 20-65.
- Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V
Who cannot join
- Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).
- Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder
- patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.
- patients with metal implants above the chest.
- people who have damaged skin in areas of the patient's body that receive stimulation.
- patients with multiple sclerosis.
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- patients who have extensive ischemic scarring.
- pregnant women.
- patients with a family history of spasms/epilepsy
- patients taking medications that may lower the seizure threshold.
- patients with severe sleep disorders related to previous rTMS treatment.
- patients with severe heart disease
- patients with intracranial stress caused by uncontrollable migraines.
- people who have been evaluated by a physician as unfit to participate in clinical trials.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Exploration of Non-invasive Theta Burst Stimulation in Patients With Methamphetamine Use Disorder: Efficacy and Mechanism
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.
Read the 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.
- Conditions
- Craving, Depression, Anxiety, Amphetamine Addiction
- Being tested
- Intermittent theta burst transcranial magnetic stimulation (iTBS), Sham stimulation
- Keywords
- Addiction, amphetamine, non-invasive theta burst stimulation
- Medical subject headings
- Depression, Anxiety Disorders, Amphetamine-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst transcranial magnetic stimulation (iTBS)Device
The amphetamine users will undergo a one-month iTBS intervention. From Week 1 to Week 4, subjects will be treated five times a week.
Sham stimulationDevice
Sham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp.
| Study group | Role | What they receive |
|---|---|---|
| theta burst stimulation | Experimental | Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes(at least), and 5 high-frequency iTBS sessions per week in total four weeks. Each session: 600-900 pulses with 120-100% resting motor threshold. Receives: Device: Intermittent theta burst transcranial magnetic stimulation (iTBS) |
| Sham arm | Sham comparator | Sham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Secondary outcomes (6)
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)
Measured: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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)
Measured: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Cognitive function
Continuous performance test was developed by Rosvold and designed as a computerized test of cognitive function.The outputs include hit rates, correct percentages, and answer time for each item. Generally, higher correct percentage with shorter answer time mean better attention.
Measured: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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)
Measured: Post intervention everytime (8 times total)
blood biomarkers
Three biomarker reflecting neuron inflammation or neuron damage will be measured using blood samples, including C-C Motif chemokine ligand 11, neurofilament light chain and exosomal RNA to explore the possible mechanism of iTBS.
Measured: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Electroencephalography
The EEG will be perform to collect the parameters across broad brain regions to transform into subsequent information of functional connectivity, including phase locking value (PLV) across all electrodes for delta, theta, alpha, and beta frequency bands.
Measured: Baseline(Week 0), Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CravingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Cheng-Che Chen, MD, MSc, Principal investigator, Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535101
- Sponsor's protocol ID
- 111-019-F
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Non-invasive Theta Burst Stimulation in Patients With Methamphetamine Use Disorder: Efficacy and Mechanism
- ClinicalTrials.gov ID
- NCT05535101
- Acronym / sponsor ID
- 111-019-F
- Conditions
- Craving, Depression, Anxiety, Amphetamine Addiction
- Keywords
- Addiction, amphetamine, non-invasive theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| theta burst stimulation | Experimental | Device: Intermittent theta burst transcranial magnetic stimulation (iTBS)Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes(at least), and 5 high-frequency iTBS sessions per week in total four weeks. Each session: 600-900 pulses with 120-100% resting motor threshold. |
| Sham arm | Sham comparator | Device: Sham stimulationSham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ranged 20-65.
- Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V
Key exclusion criteria (14 listed)
- Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).
- Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder
- patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.
- patients with metal implants above the chest.
- people who have damaged skin in areas of the patient's body that receive stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent theta burst transcranial magnetic stimulation (iTBS)The amphetamine users will undergo a one-month iTBS intervention. From Week 1 to Week 4, subjects will be treated five times a week. | Device | theta burst stimulation |
| Sham stimulationSham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp. | Device | Sham arm |
Primary outcome
Visual analogue scale (Taiwanese version)
Time frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
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.
6 secondary outcomes
The Beck depression inventory (Taiwanese version BDI)
Time frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
The Beck anxiety inventory (Taiwanese version BAI)
Time frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Cognitive function
Time frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Tolerance
Time frame: Post intervention everytime (8 times total)
blood biomarkers
Time frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16
Electroencephalography
Time frame: Baseline(Week 0), Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Che Chen, MD, MSc principal investigator
Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent theta burst transcranial magnetic stimulation (iTBS) in people with Craving and Depression, Anxiety, run by National Taiwan University Hospital Hsin-Chu Branch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheng-Che Chen, MD, MSc (0972654912, hugocc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (Taiwanese version) (time frame: Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.