Methamphetamine-dependenceNCT04139148
Transcranial Direct Current Stimulation (tDCS) Combined With Computerized Cognitive Addiction Therapy(CCAT) and, Electronic Follow-up for Methamphetamine(MA) Dependent Patients
A study testing Ture Transcranial Direct Current Stimulation (tDCS) in people with Methamphetamine-dependence and Transcranial Direct Current Stimulation, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Methamphetamine-dependence, Transcranial Direct Current Stimulation, Computerized Cognitive AddictionTherapy
- What is being tested?
- Ture Transcranial Direct Current Stimulation (tDCS)
- 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 Dec 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Methamphetamine dependent patients with normal eyesight and hearing.
Who cannot join
- any diagnosis of DSM-IV axis I diseases.
- any physical diseases which might influence cognitive function such as epilepsy, cerebrovascular disease or brain injury.
- negative behaviors or harm to others.
- cognitive enhance drug use history in last 6 months.
- other drug dependence(except nicotine).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai
Na Zhong, doctor
About this study
Official title: Study on the Effectiveness of "Treatment Regulation Mode" Based on Neuromodulation and Electronic Follow-up to Reduce Relapse Behavior in Patients With Substance Dependence
Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Electronic medical systems were applied for drug related knowledge education, self-evaluation and outpatient follow-up reminder after intervention in order to reduce relapse behaviors.
- Conditions
- Methamphetamine-dependence, Transcranial Direct Current Stimulation, Computerized Cognitive AddictionTherapy, Electronic Health Records
- Being tested
- Ture Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ture Transcranial Direct Current Stimulation (tDCS)Device
Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm).
Sham Transcranial Direct Current Stimulation (tDCS)Device
Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm).
| Study group | Role | What they receive |
|---|---|---|
| True tDCS Combined With CCAT | Active comparator | Ture transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including drug knowledge every week, self-evaluation every two weeks and outpatient follow-up reminder every four weeks. Receives: Device: Ture Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS Combined With CCAT | Sham comparator | Sham transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including only outpatient follow-up reminder every four weeks. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
| Control group | No intervention | During the treatment, the participants in control group only received treatment such as education of psychology, health and judicature, physical training as well as vocational training as usual in the compulsory rehabilitation center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline cue-induced craving at 2 weeks
Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine".
Measured: 2 weeks
Change from Baseline cue-induced craving at 4 weeks
Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine".
Measured: 4 weeks
Secondary outcomes (4)
Attention bias towards methamphetamine
A Chinese version of the MA addiction dot probe task (DPT) is used to evaluate the attention bias towards drugs.
Measured: 2 weeks，4 weeks
cognitive function
Chinese version of the CogState Battery was used to assess cognitive function.
Measured: 2 weeks，4 weeks
response inhibition function
stop signal task
Measured: 2 weeks，4 weeks
reward-related function
Delay Discounting Task
Measured: 2 weeks，4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Feb 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Na Zhong, doctor, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139148
- Sponsor's protocol ID
- NZhong-002
- Status last verified
- Oct 2019
- First submitted
- 12 Apr 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness of "Treatment Regulation Mode" Based on Neuromodulation and Electronic Follow-up to Reduce Relapse Behavior in Patients With Substance Dependence
- ClinicalTrials.gov ID
- NCT04139148
- Acronym / sponsor ID
- NZhong-002
- Conditions
- Methamphetamine-dependence, Transcranial Direct Current Stimulation, Computerized Cognitive AddictionTherapy, Electronic Health Records
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Oct 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.
Transcranial direct current stimulation (tDCS) combined with computerized cognitive addiction therapy(CCAT) for methamphetamine(MA) dependent patients in voluntary drug rehabilitation center. Electronic medical systems were applied for drug related knowledge education, self-evaluation and outpatient follow-up reminder after intervention in order to reduce relapse behaviors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| True tDCS Combined With CCAT | Active comparator | Device: Ture Transcranial Direct Current Stimulation (tDCS)Ture transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including drug knowledge every week, self-evaluation every two weeks and outpatient follow-up reminder every four weeks. |
| Sham tDCS Combined With CCAT | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)Sham transcranial direct current stimulation (tDCS) intervention combined with computerized cognitive addiction therapy(CCAT) group, last 25 minutes per day for 4 weeks(5 days/week). Electronic follow-up for 6 month including only outpatient follow-up reminder every four weeks. |
| Control group | No intervention | –During the treatment, the participants in control group only received treatment such as education of psychology, health and judicature, physical training as well as vocational training as usual in the compulsory rehabilitation center. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Methamphetamine dependent patients with normal eyesight and hearing.
Key exclusion criteria (5 listed)
- any diagnosis of DSM-IV axis I diseases.
- any physical diseases which might influence cognitive function such as epilepsy, cerebrovascular disease or brain injury.
- negative behaviors or harm to others.
- cognitive enhance drug use history in last 6 months.
- other drug dependence(except nicotine).
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 |
|---|---|---|
| Ture Transcranial Direct Current Stimulation (tDCS)Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm). | Device | True tDCS Combined With CCAT |
| Sham Transcranial Direct Current Stimulation (tDCS)Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm). | Device | Sham tDCS Combined With CCAT |
Primary outcome
Change from Baseline cue-induced craving at 2 weeks
Time frame: 2 weeks
Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine".
Change from Baseline cue-induced craving at 4 weeks
Time frame: 4 weeks
Participants were instructed to watch methamphetamine-related videos by VR and rate their level of craving after smelling and recalling the last time they engaged in drug use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for methamphetamine".
4 secondary outcomes
Attention bias towards methamphetamine
Time frame: 2 weeks，4 weeks
cognitive function
Time frame: 2 weeks，4 weeks
response inhibition function
Time frame: 2 weeks，4 weeks
reward-related function
Time frame: 2 weeks，4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Na Zhong, doctor 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 Ture Transcranial Direct Current Stimulation (tDCS) in people with Methamphetamine-dependence and Transcranial Direct Current Stimulation, 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 1 inclusion and 5 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 18 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Zhong, Doctor, doctor (008613671644472, winco917@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline cue-induced craving at 2 weeks (time frame: 2 weeks). The study lists 2 primary outcomes in all. 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 18 Nov 2019.