AddictionNCT02146014
Effects of Transcranial Direct Current Stimulation on Cigarette Addiction
A study testing Transcranial Direct Current Stimulation in people with Addiction, run by University of Brasilia at 1 site in Brazil.
Trial summary
Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Addiction
- 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
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2010to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- smokers
Who cannot join
- use of psychoactive drugs
- age above 70
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário de Brasília- HUB
Brasília, Federal District, 71910-900
About this study
Official title: Effects of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Cigarette Smoking
Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. It is currently being tried in disorders where there is abnormal brain excitability, such as epilepsy and depression. A few studies have also been able to diminish drug craving, suggesting that brain excitability might also be altered in drug addiction.
This study aims at non-invasively changing the excitability of certain brain areas-a procedure called neuromodulation- in order to help smokers quit smoking more easily.
- Conditions
- Addiction
- Being tested
- Placebo, Transcranial Direct Current Stimulation
- Keywords
- cigarette smoking, smoking
- Medical subject headings
- Behavior, Addictive, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.
In the placebo group the current will be off.
Transcranial Direct Current StimulationDevice
Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | These subjects will receive real transcranial direct current stimulation. Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS | Placebo comparator | These subjects will receive sham transcranial direct current stimulation (placebo) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Scale of Cigarette Craving
Measured: Before and 7 days after treatment
Secondary outcomes (1)
Change in Visual Analogue Scale of Motivation to Quit Smoking
Measured: Before and 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquim Brasil-Neto, University of Brasilia
- Investigators
- Raphael Boechat-Barros, MD, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146014
- Sponsor's protocol ID
- TAB-69168
- Status last verified
- May 2016
- First submitted
- 13 May 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vitor de Souza Brangioni MC, Pereira DA, Thibaut A, Fregni F, Brasil-Neto JP, Boechat-Barros R. Effects of Prefrontal Transcranial Direct Current Stimulation and Motivation to Quit in Tobacco Smokers: A Randomized, Sham Controlled, Double-Blind Trial. Front Pharmacol. 2018 Jan 26;9:14. doi: 10.3389/fphar.2018.00014. eCollection 2018.
PubMed 29434547
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Cigarette Smoking
- ClinicalTrials.gov ID
- NCT02146014
- Acronym / sponsor ID
- TAB-69168
- Conditions
- Addiction
- Keywords
- cigarette smoking, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2014 (estimated)
- 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.
Tobacco addiction is treatable with behavioral and pharmacological means, but results are often less than optimal. Transcranial direct current stimulation is a new non-invasive technique that applies weak electrical currents through the skull and has been shown to alter the excitability of certain brain areas. It is currently being tried in disorders where there is abnormal brain excitability, such as epilepsy and depression. A few studies have also been able to diminish drug craving, suggesting that brain excitability might also be altered in drug addiction.
This study aims at non-invasively changing the excitability of certain brain areas-a procedure called neuromodulation- in order to help smokers quit smoking more easily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: Transcranial Direct Current StimulationThese subjects will receive real transcranial direct current stimulation. |
| Sham tDCS | Placebo comparator | Other: PlaceboThese subjects will receive sham transcranial direct current stimulation (placebo) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- smokers
Key exclusion criteria (2 listed)
- use of psychoactive drugs
- age above 70
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 |
|---|---|---|
| PlaceboTranscranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions. In the placebo group the current will be off. | Other | Sham tDCS |
| Transcranial Direct Current StimulationTranscranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions. | Device | Transcranial Direct Current Stimulation |
Primary outcome
Change in Visual Analogue Scale of Cigarette Craving
Time frame: Before and 7 days after treatment
1 secondary outcome
Change in Visual Analogue Scale of Motivation to Quit Smoking
Time frame: Before and 7 days after intervention
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 1 Jun 2016.
- Derived from this study: PubMed 29434547Vitor de Souza Brangioni MC, Pereira DA, Thibaut A, Fregni F, Brasil-Neto JP, Boechat-Barros R. Effects of Prefrontal Transcranial Direct Current Stimulation and Motivation to Quit in Tobacco Smokers: A Randomized, Sham Controlled, Double-Blind Trial. Front Pharmacol. 2018 Jan 26;9:14. doi: 10.3389/fphar.2018.00014. eCollection 2018.
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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.
Raphael Boechat-Barros, MD principal investigator
University of Brasilia
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 Addiction, run by University of Brasilia at 1 site in Brazil.
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 2 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 1 Jun 2016. 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 Brazil. 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?
Change in Visual Analogue Scale of Cigarette Craving (time frame: Before and 7 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02146014, which also lists 1 linked publication.
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 1 Jun 2016; AzTrials last refreshed its copy on 6 Nov 2026.