Alcohol Use DisorderNCT04135599
A Study of the Effectiveness of Direct Current Stimulation for Alcohol Use Disorders
A study testing transcranial direct current stimulation in people with Alcohol Use Disorder, run by Shanghai Mental Health Center.
Trial summary
Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2019to 30 Apr 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 60 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria:(1)Clinical diagnosis of severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); (2)Must be able to look and hear; (3) Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score less than 10.
Exclusion Criteria:(1) Clinical diagnosis of substance use disorder other than an alcohol or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)；(2) Severe brain injury, stroke, seizure, epilepsy or other major neurological diseases ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for fMRI scanning.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transcranial Direct Current Stimulation of the Bilateral Dorsolateral Prefrontal Cortex for Alcohol Use Disorders: A Randomised, Sham-controlled Clinical Trial
Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving in drug addiction.
Objective:In this study, the investigators employed real and sham tDCS of the bilateral dorsolateral prefrontal cortex (DLPFC) to test the effect of whether it could reduce cue-induced craving, influence cognitive function in alcoholics and explore its underlying mechanism with functional magnetic resonance imaging (fMRI).
Read more
Methods: The investigators perform a randomized sham-controlled study in which 40 inpatient alcoholics will be randomized to receive 10 sessions of 20min sham or 1.5mA tDCS to the bilateral DLPFC (anodal right/cathodal left). The neuroimaging data, craving after exposed to alcohol-associated cues and the cognition task at baseline and after stimulation will be collected.
The investigators hypothesized that tDCS stimulating the DLPFC decreases cue-induced craving and improves cognition, which might be associated with the functional connectivity alterations.
- Conditions
- Alcohol Use Disorder
- Being tested
- transcranial direct current stimulation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving and improve cognition in drug addiction.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS | Active comparator | Participants received 1.5mA tDCS for 20 minutes in 10 consecutive days. Receives: Device: transcranial direct current stimulation |
| sham tDCS | Sham comparator | Participants received sham tDCS for 20 minutes in 10 consecutive days. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline functional magnetic resonance imaging at 2 weeks
Stop signal task during fMRI scanning (Philips Ingenia 3.0T MRI).
Measured: Two weeks
Secondary outcomes (3)
cue-induced craving
Participants were instructed to pay close attention to real alcoholic beverages and rate their level of craving after smelling and recalling the last time they engaged in alcohol use. Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for alcohol".
Measured: Two weeks
Cognitive function
Chinese version of the CogState Battery was used to assess cognitive function. We selected two tasks: Two back task (working memory) and Identification task (attention) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task and the speed in Identification task are our focus.
Measured: Two weeks
Relapse
Meet the criteria for mild to severe AUD defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5)
Measured: One month after discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start31 Oct 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 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
- NCT04135599
- Sponsor's protocol ID
- NZhong-004
- Status last verified
- Jun 2019
- First submitted
- 28 Sep 2019
- Last updated
- 22 Oct 2019
- 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 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation of the Bilateral Dorsolateral Prefrontal Cortex for Alcohol Use Disorders: A Randomised, Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04135599
- Acronym / sponsor ID
- NZhong-004
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 31 Oct 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 22 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) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving in drug addiction.
Objective:In this study, the investigators employed real and sham tDCS of the bilateral dorsolateral prefrontal cortex (DLPFC) to test the effect of whether it could reduce cue-induced craving, influence cognitive function in alcoholics and explore its underlying mechanism with functional magnetic resonance imaging (fMRI).
Methods: The investigators perform a randomized sham-controlled study in which 40 inpatient alcoholics will be randomized to receive 10 sessions of 20min sham or 1.5mA tDCS to the bilateral DLPFC (anodal right/cathodal left). The neuroimaging data, craving after exposed to alcohol-associated cues and the cognition task at baseline and after stimulation will be collected.
The investigators hypothesized that tDCS stimulating the DLPFC decreases cue-induced craving and improves cognition, which might be associated with the functional connectivity alterations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS | Active comparator | Device: transcranial direct current stimulationParticipants received 1.5mA tDCS for 20 minutes in 10 consecutive days. |
| sham tDCS | Sham comparator | Device: transcranial direct current stimulationParticipants received sham tDCS for 20 minutes in 10 consecutive days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 direct current stimulationTranscranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving and improve cognition in drug addiction. | Device | real tDCS, sham tDCS |
Primary outcome
Change from baseline functional magnetic resonance imaging at 2 weeks
Time frame: Two weeks
Stop signal task during fMRI scanning (Philips Ingenia 3.0T MRI).
3 secondary outcomes
cue-induced craving
Time frame: Two weeks
Cognitive function
Time frame: Two weeks
Relapse
Time frame: One month after discharge from the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
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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
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Alcohol Use Disorder, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Oct 2019. 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 Na Zhong, 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 functional magnetic resonance imaging at 2 weeks (time frame: Two 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 22 Oct 2019.