CravingNCT04993300
Repetitive Transcranial Magnetic Stimulation in Amphetamine Addiction
A study testing transcranial magnetic stimulation (TMS) in people with Craving and Depression, Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. 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?
- transcranial magnetic stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2022to 4 Aug 2022
- 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.
- Under judicially supervised outpatient-based methamphetamine abuse treatment program
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 who have metal implants in their bodies, as well as those with metal implants.
- 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
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation in Treatment of Taiwanese Amphetamine Users: A Pilot Study
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.
Read the 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
- Being tested
- transcranial magnetic stimulation (TMS)
- Keywords
- Addiction, amphetamine, transcranial magnetic 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.
transcranial magnetic stimulation (TMS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| transcranial magnetic stimulation (TMS) | Experimental | This arm constitute of methamphetamine users who undergone abstinent period Receives: Device: transcranial magnetic stimulation (TMS) |
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: 20 weeks
Secondary outcomes (4)
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: 20 weeks
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: 20 weeks
Cognitive function
Continuous performance test was developed by Rosvold and designed as a computerized test of cognitive function.
Measured: 20 weeks
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: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start17 Feb 2022
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Chen Cheng-Che, MD,MSc, Principal investigator, Physician, Department if Psychiatry, National Taiwan University Hospital - Biomedical Park Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993300
- Sponsor's protocol ID
- 202010115DINA
- Status last verified
- Mar 2023
- First submitted
- 21 Jul 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation in Treatment of Taiwanese Amphetamine Users: A Pilot Study
- ClinicalTrials.gov ID
- NCT04993300
- Acronym / sponsor ID
- 202010115DINA
- Conditions
- Craving, Depression, Anxiety, Amphetamine Addiction
- Keywords
- Addiction, amphetamine, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 6 Aug 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transcranial magnetic stimulation (TMS) | Experimental | Device: transcranial magnetic stimulation (TMS)This arm constitute of methamphetamine users who undergone abstinent period |
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.
- Under judicially supervised outpatient-based methamphetamine abuse treatment program
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 who have metal implants in their bodies, as well as those with metal implants.
- 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 |
|---|---|---|
| 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. | Device | transcranial magnetic stimulation (TMS) |
Primary outcome
Visual analogue scale (Taiwanese version)
Time frame: 20 weeks
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.
4 secondary outcomes
The Beck depression inventory (Taiwanese version BDI)
Time frame: 20 weeks
The Beck anxiety inventory (Taiwanese version BAI)
Time frame: 20 weeks
Cognitive function
Time frame: 20 weeks
Tolerance
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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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.
Chen Cheng-Che, MD,MSc principal investigator
Physician, Department if Psychiatry, National Taiwan University Hospital - Biomedical Park Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation (TMS) in people with Craving and Depression, Anxiety, run by National Taiwan University Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (Taiwanese version) (time frame: 20 weeks). 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 30 Mar 2023.