AddictionNCT01288183
Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction
A study testing active tDCS in people with Addiction and Smoking, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- active tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Dec 2014
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 18 to 55 years old
- Tobacco consumption from 10 to 25 cigarettes, for at least 1 year
- Strong tobacco dependence at the Fagerstrom Test (score >= 5)
- Motivation to quit with a score >=12 at the Motivation to Quit Smoking Scale (Q-MAT)
- Informed consent
Who cannot join
- Concomitant Axe I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- Other addictive disorder (DSM IV)
- No history of smoking cessation drug the previous year
- Psychotropic treatment
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers
The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction.
Read the detailed description
Tobacco is estimated to cause more than 5 millions yearly deaths in the developed world. Although most smokers would like to quit, relapse rates remain high. It seems that this relapse is linked with the process of craving, which is a powerful desire to smoke elicited by smoking deprivation or exposure to situations or cues that are associated with smoking. Neuroimaging studies have shown that the dorsolateral prefrontal cortex (DLPFC), and especially the right part, is critically involved in processing the craving of smoking. Increasing the activity of the DLPFC by noninvasive brain stimulation has been demonstrated to be effective in decreasing craving symptoms in cigarette smokers.
The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking. tDCS is a painless and safe brain stimulation method capable of modulating cortical excitability. The nature of these modulations depends on stimulation polarity: anodal tDCS is thought to cause neuronal depolarisation and thus enhancing cortical excitability whereas cathodal stimulation is proposed to reduce excitability. The investigators hypothesize that anodal tDCS applied repetitively to the right DLPFC could constitute a treatment of tobacco addiction. Therefore, the investigators will conduct a sham-tDCS-controlled, randomized, double-blind study.
- Being tested
- sham tDCS, active tDCS
- Keywords
- tobacco, smoking, tDCS, DLPFC
- Medical subject headings
- Behavior, Addictive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham tDCSProcedure or surgery
sham condition as delivered by the stimulator "study mode" (2mA during 40s and brief current pulses until the end of the stimulation) 20 minutes, 10 sessions, 2 per day
active tDCSProcedure or surgery
anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Sham comparator | sham transcranial direct current stimulation The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Receives: Procedure: sham tDCS |
| active tDCS | Active comparator | active anodal tDCS over the right dorsolateral prefrontal cortex The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Intensity of the stimulation: 2 mA Duration of the stimulation: 20 min 10 sessions, 2 per day Receives: Procedure: active tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking
Self-reported number of cigarettes smoked each day
Measured: Baseline (three days before starting tDCS regimen) to one-month after
Secondary outcomes (3)
Exhaled carbon monoxide
measured using a CO monitor (MicroCo, Milford, MA, USA).
Measured: Baseline, one-week (after the last tDCS session) and one-month later
Craving
measured using a 5-item Likert-type scale questionnaire of smoking urge
Measured: For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)
fMRI brain reactivity during a smoking cue-reactivity task
measured using an event-related fMRI paradigm
Measured: Baseline and one-week (after the last tDCS session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. E. Poulet, Hôpital le Vinatier
- Investigators
- JEROME BRUNELIN, PhD, Study director, Hopital le VinatierEmmanuel POULET, MD, PhD, Principal investigator, Hopital le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288183
- Sponsor's protocol ID
- 2010-A00180-39
- Status last verified
- Jan 2018
- First submitted
- 27 Jan 2011
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Impact of Prefrontal Anodal Transcranial Direct Current Stimulation on Smokers
- ClinicalTrials.gov ID
- NCT01288183
- Acronym / sponsor ID
- 2010-A00180-39
- Keywords
- tobacco, smoking, tDCS, DLPFC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Feb 2011 (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.
The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction.
Detailed description
Tobacco is estimated to cause more than 5 millions yearly deaths in the developed world. Although most smokers would like to quit, relapse rates remain high. It seems that this relapse is linked with the process of craving, which is a powerful desire to smoke elicited by smoking deprivation or exposure to situations or cues that are associated with smoking. Neuroimaging studies have shown that the dorsolateral prefrontal cortex (DLPFC), and especially the right part, is critically involved in processing the craving of smoking. Increasing the activity of the DLPFC by noninvasive brain stimulation has been demonstrated to be effective in decreasing craving symptoms in cigarette smokers.
The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking. tDCS is a painless and safe brain stimulation method capable of modulating cortical excitability. The nature of these modulations depends on stimulation polarity: anodal tDCS is thought to cause neuronal depolarisation and thus enhancing cortical excitability whereas cathodal stimulation is proposed to reduce excitability. The investigators hypothesize that anodal tDCS applied repetitively to the right DLPFC could constitute a treatment of tobacco addiction. Therefore, the investigators will conduct a sham-tDCS-controlled, randomized, double-blind study.
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 |
|---|---|---|
| sham tDCS | Sham comparator | Procedure: sham tDCSsham transcranial direct current stimulation The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region |
| active tDCS | Active comparator | Procedure: active tDCSactive anodal tDCS over the right dorsolateral prefrontal cortex The anode (7 x 5 cm) is placed on the right dorsolateral prefrontal cortex. A large cathode (10 x 10cm) is placed on the left occipital region Intensity of the stimulation: 2 mA Duration of the stimulation: 20 min 10 sessions, 2 per day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 18 to 55 years old
- Tobacco consumption from 10 to 25 cigarettes, for at least 1 year
- Strong tobacco dependence at the Fagerstrom Test (score >= 5)
- Motivation to quit with a score >=12 at the Motivation to Quit Smoking Scale (Q-MAT)
- Informed consent
Key exclusion criteria (5 listed)
- Concomitant Axe I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- Other addictive disorder (DSM IV)
- No history of smoking cessation drug the previous year
- Psychotropic treatment
- Pregnancy or nursing
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 |
|---|---|---|
| sham tDCSsham condition as delivered by the stimulator "study mode" (2mA during 40s and brief current pulses until the end of the stimulation) 20 minutes, 10 sessions, 2 per day | Procedure or surgery | sham tDCS |
| active tDCSanodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day | Procedure or surgery | active tDCS |
Primary outcome
Smoking
Time frame: Baseline (three days before starting tDCS regimen) to one-month after
Self-reported number of cigarettes smoked each day
3 secondary outcomes
Exhaled carbon monoxide
Time frame: Baseline, one-week (after the last tDCS session) and one-month later
Craving
Time frame: For each of the 10 tDCS sessions: Baseline and 0 hour post-tDCS (immediately after)
fMRI brain reactivity during a smoking cue-reactivity task
Time frame: Baseline and one-week (after the last tDCS session)
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 26 Jan 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.
JEROME BRUNELIN, PhD study director
Hopital le Vinatier
Emmanuel POULET, MD, PhD principal investigator
Hopital le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Addiction and Smoking, run by Hôpital le Vinatier at 1 site in France.
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 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: finished, as of the sponsor's last update on 26 Jan 2018. 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 France. 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?
Smoking (time frame: Baseline (three days before starting tDCS regimen) to one-month after). 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 26 Jan 2018.