Methamphetamine-dependenceNCT03827785
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence
A study testing rTMS treatment group in people with Methamphetamine-dependence, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA) addiction in previous studies, while the evidence-based protocols still required. The aim of this research is to evaluating the effectiveness and safety of rTMS treatment in improving the days of abstinence maintenance. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine-dependence
- What is being tested?
- rTMS treatment group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 12 Dec 2020
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Junior high school degree or above
- Normal vision and hearing
- Dextromanual
- Less than one month before last drug use
Who cannot join
- Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
- Have cognitive-promoting drugs in the last 6 months
- Other substance abuse or dependence in recent five years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
- Physical disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA) addiction in previous studies, while the evidence-based protocols still required. The aim of this research is to evaluating the effectiveness and safety of rTMS treatment in improving the days of abstinence maintenance. In addition, treatment effect on cognitive impairment, psychological craving and depression are also evaluated during the study.
Read the detailed description
First, a multicenter, double-blind, randomized control study is going to be carried out. 100 recruited patients will be randomized assigned to the intervention group and the control group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test follow-up (1 time per week). Negative rate of urine test during the follow-up period is set as primary outcome. Cognitive function, craving, depression are also evaluated before and after the intervention.
Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of relapse for both the patients and their families.
- Conditions
- Methamphetamine-dependence
- Being tested
- rTMS treatment group, sham rTMS treatment group
- Keywords
- repetitive transcranial magnetic stimulation (rTMS), randomized clinical trials, treatment, craving, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS treatment groupDevice
For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.
sham rTMS treatment groupDevice
For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| rTMS treatment group | Experimental | Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days. Receives: Device: rTMS treatment group |
| sham rTMS treatment group | Sham comparator | Stimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days. Receives: Device: sham rTMS treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative rate urine test
After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive.
Negative rate of urine drug test = actual number of negative urine tests / 12.
Measured: 12 weeks
Secondary outcomes (3)
Change of Craving assessed by Visual Analog Scale
evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.
Measured: 12 weeks
Cognitive function assessed by CogState Battery (CSB)
evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version
Measured: 12 weeks
Depression status assessed by Hamilton depression scale (HAMD-17)
Evaluate all participants' depression status by Hamilton depression scale (HAMD-17) HAMD can be summarized into 7 types of factor structure: (1) anxiety/somatization:; (2) weight: weight loss (3) Cognitive obstacles; (4) day and night changes; (5) Block; (6) sleep disorder; (7) feeling of despair. The total score can reflect the severity of the symptom, that is, The lighter the symptoms, the lower the score, and vice versa. Mild depression: HAMD 17 scores > 7 points, ≤ 17 points; moderate depression: HAMD 17 scores > 17 points, ≤ 24 points; severe depression: HAMD 17 scores > 24 points.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start1 Feb 2019
- Primary completion1 Sep 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine-dependenceStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wuxi Mental Health Center, Jiangsu Provence, China, Suzhou Guangji Hospital, Jiangsu Provence, China, Wuhan Mental Health Centre, Yunnan Institute For Drug Abuse
- Responsible party
- Sponsor
- Investigators
- Haifeng Jiang, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827785
- Sponsor's protocol ID
- HFJiang-002
- Status last verified
- Sep 2021
- First submitted
- 30 Jan 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Repeated Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence: a Multicenter, Double-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03827785
- Acronym / sponsor ID
- HFJiang-002
- Conditions
- Methamphetamine-dependence
- Keywords
- repetitive transcranial magnetic stimulation (rTMS), randomized clinical trials, treatment, craving, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Wuxi Mental Health Center, Jiangsu Provence, China, Suzhou Guangji Hospital, Jiangsu Provence, China, Wuhan Mental Health Centre, Yunnan Institute For Drug Abuse
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 1 Feb 2019 (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.
Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA) addiction in previous studies, while the evidence-based protocols still required. The aim of this research is to evaluating the effectiveness and safety of rTMS treatment in improving the days of abstinence maintenance. In addition, treatment effect on cognitive impairment, psychological craving and depression are also evaluated during the study.
Detailed description
First, a multicenter, double-blind, randomized control study is going to be carried out. 100 recruited patients will be randomized assigned to the intervention group and the control group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test follow-up (1 time per week). Negative rate of urine test during the follow-up period is set as primary outcome. Cognitive function, craving, depression are also evaluated before and after the intervention.
Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of relapse for both the patients and their families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS treatment group | Experimental | Device: rTMS treatment groupStimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 30 days. |
| sham rTMS treatment group | Sham comparator | Device: sham rTMS treatment groupStimulate the dorsal lateral prefrontal cortex with the sham iTBS pattern and coil. The therapy will be conductedfor 30 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
- Junior high school degree or above
- Normal vision and hearing
- Dextromanual
- Less than one month before last drug use
Key exclusion criteria (6 listed)
- Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
- Have cognitive-promoting drugs in the last 6 months
- Other substance abuse or dependence in recent five years (except nicotine)
- Mental impairment, Intelligence Quotient (IQ) < 70
- Mental disorders
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 |
|---|---|---|
| rTMS treatment groupFor rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days. | Device | rTMS treatment group |
| sham rTMS treatment groupFor sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days. | Device | sham rTMS treatment group |
Primary outcome
Negative rate urine test
Time frame: 12 weeks
After treatment, patients will be asked to participate urine test for 12 times once a week. Loss of visit or rejection for urine test will be treated as urine test positive. Negative rate of urine drug test = actual number of negative urine tests / 12.
3 secondary outcomes
Change of Craving assessed by Visual Analog Scale
Time frame: 12 weeks
Cognitive function assessed by CogState Battery (CSB)
Time frame: 12 weeks
Depression status assessed by Hamilton depression scale (HAMD-17)
Time frame: 12 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 16 Sep 2021.
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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.
Haifeng Jiang principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS treatment group in people with Methamphetamine-dependence, run by Shanghai Mental Health Center at 1 site in China.
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 5 inclusion and 6 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 16 Sep 2021. 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 China. 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. 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?
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?
Negative rate urine test (time frame: 12 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 16 Sep 2021.