Alcohol DependenceNCT05854693
Trans-cranial Direct Current Stimulation on Alcohol Craving
A study testing transCranial direct current stimulation in people with Alcohol Dependence, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tDCS) for alcohol craving in individuals with alcohol dependence. The main question it aims to answer is whether 10 sessions of tDCS can reduce craving for alcohol. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Alcohol Dependence
- 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
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Apr 2023to Jun 2026
- 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
- Be between 20-65 years of age
- have sufficient cognitive function to understand the study and complete the informed consent process
- Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.)
Who cannot join
- Intellectual disabilities
- bipolar disorder
- Psychosis (schizophrenia)
- Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures)
- intracorporeal electronic or metal implants (e.g., cardiac pacemaker)
- Pregnant or breastfeeding women
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- Allergy to headgear and electrode materials
- Trauma or infection to the head
- Intracranial space occupied lesion (such as brain tumor, AVM, etc.) or patients who have undergone brain surgery, meningitis and encephalitis
- Patients who are expected to undergo brain and major surgery during the trial period
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital
Taipei, Taipei CITY, 105
Hu-Ming Chang, 0978052951, DAU66@tpech.gov.tw
About this study
Official title: Exploring the Effect of Trans-cranial Direct Current Stimulation on Craving and Serum BDNF of Patients With Alcohol Dependence
The goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tDCS) for alcohol craving in individuals with alcohol dependence. The main question it aims to answer is whether 10 sessions of tDCS can reduce craving for alcohol.
Participants will be randomized into active group and sham group. Researchers will compare the severity of craving in these groups.
Read the detailed description
Craving is defined as strong desire for substance use, and is one of the core symptoms of alcohol dependence which is highly correlated with relapse. Transcranial direct current stimulation (tDCS) involves applying a small direct current (1-2mA) to the prefrontal cortex; its therapeutic effect for depression and cognition has been demonstrated by several randomized studies. Our preliminary study has shown that tDCS has the potential to reduce craving in alcohol-dependent patients without adverse events. Furthermore, our previous studies have shown that serum brain-derived neurotrophic factor (BDNF) level is elevated after alcohol withdrawal. The current study aims at examining the association between craving and serum BDNF level in alcohol-dependent patients receiving tDCS. The study recruits 40 patients with alcohol dependence. Patients will receive tDCS for 2 weeks during admission, and followed for 2 weeks after tDCS. We'll compare their improvements in craving scores every week, and investigate the correlation between craving and serum BDNF level. This study will bring innovations to the treatment of alcohol dependence based on our previous studies.
- Conditions
- Alcohol Dependence
- Being tested
- transCranial direct current stimulation, sham stimulation
- Keywords
- Transcranial Direct Current Stimulation, craving
- 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
The intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS
sham stimulationDevice
The sham group consisted of 10 daily 20-min sessions of sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | The intervention consisted of 10 daily 20-min sessions of bilateral prefrontal tDCS (anodal-right/cathodal-left, 2mA; 1 × 1 Mini-CT) Receives: Device: transCranial direct current stimulation |
| Sham tDCS | Sham comparator | The sham group consisted of 10 daily 20-min sessions of sham stimulation Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alcohol craving
Measured by visual analog scale, from 0-10
Measured: Before intervention (week 0) and after intervention (week 2)
Secondary outcomes (1)
Change in brain-derived neurotrophic factor (BDNF)
Serum level of BDNF
Measured: Before intervention (week 0) and after intervention (week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start17 Apr 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854693
- Sponsor's protocol ID
- TCHIRB-10907010
- Status last verified
- May 2022
- First submitted
- 18 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Trans-cranial Direct Current Stimulation on Craving and Serum BDNF of Patients With Alcohol Dependence
- ClinicalTrials.gov ID
- NCT05854693
- Acronym / sponsor ID
- TCHIRB-10907010
- Conditions
- Alcohol Dependence
- Keywords
- Transcranial Direct Current Stimulation, craving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 May 2023 (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 goal of thisclinical trial is to investigate the efficacy of trans cranial direct current stimulation (tDCS) for alcohol craving in individuals with alcohol dependence. The main question it aims to answer is whether 10 sessions of tDCS can reduce craving for alcohol.
Participants will be randomized into active group and sham group. Researchers will compare the severity of craving in these groups.
Detailed description
Craving is defined as strong desire for substance use, and is one of the core symptoms of alcohol dependence which is highly correlated with relapse. Transcranial direct current stimulation (tDCS) involves applying a small direct current (1-2mA) to the prefrontal cortex; its therapeutic effect for depression and cognition has been demonstrated by several randomized studies. Our preliminary study has shown that tDCS has the potential to reduce craving in alcohol-dependent patients without adverse events. Furthermore, our previous studies have shown that serum brain-derived neurotrophic factor (BDNF) level is elevated after alcohol withdrawal. The current study aims at examining the association between craving and serum BDNF level in alcohol-dependent patients receiving tDCS. The study recruits 40 patients with alcohol dependence. Patients will receive tDCS for 2 weeks during admission, and followed for 2 weeks after tDCS. We'll compare their improvements in craving scores every week, and investigate the correlation between craving and serum BDNF level. This study will bring innovations to the treatment of alcohol dependence based on our previous studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: transCranial direct current stimulationThe intervention consisted of 10 daily 20-min sessions of bilateral prefrontal tDCS (anodal-right/cathodal-left, 2mA; 1 × 1 Mini-CT) |
| Sham tDCS | Sham comparator | Device: sham stimulationThe sham group consisted of 10 daily 20-min sessions of sham stimulation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be between 20-65 years of age
- have sufficient cognitive function to understand the study and complete the informed consent process
- Be diagnosed with alcohol dependence as defined by DSM-IV through a structured interview (Mini-International Neuropsychiatric Interview, M.I.N.I.)
Key exclusion criteria (10 listed)
- Intellectual disabilities
- bipolar disorder
- Psychosis (schizophrenia)
- Major physical illness (brain hemorrhage, brain tumor, myocardial infarction, epilepsy or history of seizures)
- intracorporeal electronic or metal implants (e.g., cardiac pacemaker)
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 stimulationThe intervention consisted of 20 daily 20-min sessions of bilateral prefrontal tDCS | Device | Active tDCS |
| sham stimulationThe sham group consisted of 10 daily 20-min sessions of sham stimulation | Device | Sham tDCS |
Primary outcome
Change in alcohol craving
Time frame: Before intervention (week 0) and after intervention (week 2)
Measured by visual analog scale, from 0-10
1 secondary outcome
Change in brain-derived neurotrophic factor (BDNF)
Time frame: Before intervention (week 0) and after intervention (week 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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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.
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 direct current stimulation in people with Alcohol Dependence, run by Taipei City 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 3 inclusion and 10 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 11 May 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. 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 Hu-Ming Chang (0978052951, DAU66@tpech.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol craving (time frame: Before intervention (week 0) and after intervention (week 2)). 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 11 May 2023.