Tobacco Use DisorderTABELECNCT01930422
Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption
A study testing tDCS procedure in people with Tobacco Use Disorder, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- tDCS procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Feb 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 to 60 years old
- Smoking ≥ 5 years
- Smoking ≥ 15 manufactured cigarettes per day or ≥ 10 rolled cigarettes per day
- Fagerström test ≥ 5
- Smokers who have at least an attempt to stop of minimum 7 days
- Written informed consent signed by the patient
- Affiliated to medical insurance
Who cannot join
- Co-addiction (cannabis, alcohol, other drugs)
- HAD test: D ≥ 8; A + D ≥ 19
- Treatment by nicotine replacement therapy, bupropion or varenicline within 30 days prior inclusion
- Neuropsychiatric disease, considered serious by the investigator
- Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)
- Skin scalp dermatosis
Show all 9Show fewer
- Pregnancy or breastfeeding. Positive pregnancy test.
- Patient under guardianship, trusteeship or judicial protection
- Patient in inclusion period for another clinical research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.
The primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.
The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.
Read the detailed description
Smoking is a major public health problem and it is the leading cause of preventable death in the world. Care should include education, psychotherapy and treatments, but despite these therapeutics, the smoking cessation process is often characterized by relapses. The main risk factor for relapse is craving. Neurophysiological studies have provided evidence in the understanding of craving. This craving involves surface structures including the dorsolateral prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on this structures involved in craving could therefore modulate it. Two non-invasive stimulation techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent tolerance, its better quality of placebo and low cost.
- Conditions
- Tobacco Use Disorder
- Being tested
- tDCS procedure, Sham procedure
- Keywords
- Direct transcranial electrical stimulation (tDCS), Sham procedure, Tobacco consumption, Craving
- Medical subject headings
- Tobacco Use Disorder, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS procedureDevice
The tDCS is a non-invasive neuromodulation method. A stimulator delivers a constant current of low intensity (1-2 mA) applied to the average of two bipolar electrodes placed on the scalp for 20 minutes. This constant current generates a static electric field that selectively modulates the activity of cortical neurones. A tingling sensation under the electrodes appears at the beginning and at the end of stimulation but it is transient and disappears quickly in 30 or 60 seconds.
Sham procedureDevice
The tDCS placebo differs from the real tDCS by the interruption of stimulation after 30 to 60 seconds and reactivation of this stimulation 30 to 60 seconds before the end of the session, which lasted 20 minutes. The tingling felt at the beginning and the end of the session will be the same as those experienced with real stimulation. The electrodes establishment does not differ with respect to tDCS.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | Direct transcranial electrical stimulation (tDCS procedure) Receives: Device: tDCS procedure |
| Placebo tDCS | Sham comparator | Sham procedure Receives: Device: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change of individual salivary cotinine.
Measured: Outcome measure is assessed at Day1 and Day5
Secondary outcomes (5)
Relative change of individual salivary cotinine
Measured: Outcome measure is assessed at Day5 and between Day15 and Day20.
Exhaled carbon monoxide.
Measured: Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.
Number of cigarettes smoked per day
Measured: Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20
Technical feasibility of outpatient
The feasibility is assessed by the number of smokers following the entire protocol.
Measured: Outcome measure is assessed between day 15 and 20.
Measurement of craving
Measurement of craving from Day1 to Day5 and at the final visits assessed by a VAS: visual analogue scale from 0 (no urge to smoke at all) to 10 (intense desire compelling smoking) and the questionnaire called the 12-item French Tobacco Craving Questionnaire (FCTQ-12).
Measured: Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (77)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rose-Marie ROUQUET, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930422
- Sponsor's protocol ID
- 12 392 02
- Other IDs
- AOL 2012
- Acronym
- TABELEC
- Status last verified
- Feb 2014
- First submitted
- 20 Jun 2013
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Organisation Mondiale de la Santé. Rapport de l'OMS sur l'épidémie mondiale de tabagisme 2011, résumé d'orientation. OMS 2011
Rapport OMS Mpower 2008.
Observatoire français des drogues et des toxicomanies. Les niveaux d'usage des drogues en France en 2010. OFDT Tendances, n°76, juin 2011
Le Faou AL, Scemama O. [Epidemiology of tobacco smoking]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S27-32. French.
PubMed 16340832Hill C, Jougla E, Beck F. Le point sur l'épidémie de cancer du poumon dû au tabagisme. BEH mai 2010; 19-20: 210-213
Fuxe, K., Anderson, K., Eneroth, P., 1987. Effects of nicotine and exposure to cigarette smoke on discrete dopamine and noradrenaline nerve terminal systems of the telcephalon and diencephalon of the rat: relationship to reward mechanisms and distribution of nicotine binding sites in brain. In: Martin, W.R., Van Loon, G.R., Iwamoto, E.T., et al. (Eds.), Tobacco Smoking and Nicotine: A Neurobiological Approach. Plenum, New York, pp. 225-262.
Pert, A., Clarke, P.B.S., 1987. Nicotine modulation of dopaminergic transmission: functional implications. In: Martin, W.R., Van Loon, G.R., Iwamoto, E.T., et al. (Eds.), Tobacco, Smoking and Nicotine: A Neurobiological Approach. Plenum, New York, pp.169-189.
United States Department of Health and Human Services, 1988. The Health Consequences of Smoking: Nicotine Addiction. US Government Printing Office, Washington, DC DHHS Publication No.CDC-88-8406.
Clarke, P., 1990. Mesolimbic dopaminergic activation: the key to nicotine reinforcement. In: Bock, G., Marsh, J. (Eds.), The Biology of Nicotine Dependence. Wiley, New York, pp. 153-168.
Pich EM, Pagliusi SR, Tessari M, Talabot-Ayer D, Hooft van Huijsduijnen R, Chiamulera C. Common neural substrates for the addictive properties of nicotine and cocaine. Science. 1997 Jan 3;275(5296):83-6. doi: 10.1126/science.275.5296.83.
PubMed 8974398Wise RA, Bozarth MA. A psychomotor stimulant theory of addiction. Psychol Rev. 1987 Oct;94(4):469-92. No abstract available.
PubMed 3317472Collins AC, Marks MJ. Progress towards the development of animal models of smoking-related behaviors. J Addict Dis. 1991;10(1-2):109-26. doi: 10.1300/J069v10n01_08.
PubMed 2065112Pomerleau OF. Individual differences in sensitivity to nicotine: implications for genetic research on nicotine dependence. Behav Genet. 1995 Mar;25(2):161-77. doi: 10.1007/BF02196925.
PubMed 7733857Robinson TE, Berridge KC. The neural basis of drug craving: an incentive-sensitization theory of addiction. Brain Res Brain Res Rev. 1993 Sep-Dec;18(3):247-91. doi: 10.1016/0165-0173(93)90013-p.
PubMed 8401595Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption.
- ClinicalTrials.gov ID
- NCT01930422
- Acronym / sponsor ID
- TABELEC / 12 392 02
- Conditions
- Tobacco Use Disorder
- Keywords
- Direct transcranial electrical stimulation (tDCS), Sham procedure, Tobacco consumption, Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Aug 2013 (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 primary purpose of the protocol is to evaluate the effect of repeated application for 5 consecutive days of a real tDCS compared to the application of a placebo tDCS (sham procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.
The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on the left dorsolateral prefrontal cortex region will reduce the craving induced causing a decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final visit between Day 15 and Day 20.
Detailed description
Smoking is a major public health problem and it is the leading cause of preventable death in the world. Care should include education, psychotherapy and treatments, but despite these therapeutics, the smoking cessation process is often characterized by relapses. The main risk factor for relapse is craving. Neurophysiological studies have provided evidence in the understanding of craving. This craving involves surface structures including the dorsolateral prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on this structures involved in craving could therefore modulate it. Two non-invasive stimulation techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent tolerance, its better quality of placebo and low cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: tDCS procedureDirect transcranial electrical stimulation (tDCS procedure) |
| Placebo tDCS | Sham comparator | Device: Sham procedureSham procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18 to 60 years old
- Smoking ≥ 5 years
- Smoking ≥ 15 manufactured cigarettes per day or ≥ 10 rolled cigarettes per day
- Fagerström test ≥ 5
- Smokers who have at least an attempt to stop of minimum 7 days
Key exclusion criteria (9 listed)
- Co-addiction (cannabis, alcohol, other drugs)
- HAD test: D ≥ 8; A + D ≥ 19
- Treatment by nicotine replacement therapy, bupropion or varenicline within 30 days prior inclusion
- Neuropsychiatric disease, considered serious by the investigator
- Psychotropic treatment (antidepressant, anxiolytic, antipsychotic)
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 |
|---|---|---|
| tDCS procedureThe tDCS is a non-invasive neuromodulation method. A stimulator delivers a constant current of low intensity (1-2 mA) applied to the average of two bipolar electrodes placed on the scalp for 20 minutes. This constant current generates a static electric field that selectively modulates the activity of cortical neurones. A tingling sensation under the electrodes appears at the beginning and at the end of stimulation but it is transient and disappears quickly in 30 or 60 seconds. | Device | Real tDCS |
| Sham procedureThe tDCS placebo differs from the real tDCS by the interruption of stimulation after 30 to 60 seconds and reactivation of this stimulation 30 to 60 seconds before the end of the session, which lasted 20 minutes. The tingling felt at the beginning and the end of the session will be the same as those experienced with real stimulation. The electrodes establishment does not differ with respect to tDCS. | Device | Placebo tDCS |
Primary outcome
Relative change of individual salivary cotinine.
Time frame: Outcome measure is assessed at Day1 and Day5
5 secondary outcomes
Relative change of individual salivary cotinine
Time frame: Outcome measure is assessed at Day5 and between Day15 and Day20.
Exhaled carbon monoxide.
Time frame: Outcome measure is assessed at day 0, day 1, day 2, day 3, day 4, day 5 and between day 15 and day 20.
Number of cigarettes smoked per day
Time frame: Outcome measure is assessed at day 0, day1, day2, day3, day4, day5 and between day 15 and 20
Technical feasibility of outpatient
Time frame: Outcome measure is assessed between day 15 and 20.
Measurement of craving
Time frame: Outcome measure is assessed at Day1, day2, day3, day4, day5 and betwenn day 15 to day 20.
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 24 Feb 2014.
- BackgroundOrganisation Mondiale de la Santé. Rapport de l'OMS sur l'épidémie mondiale de tabagisme 2011, résumé d'orientation. OMS 2011
- BackgroundRapport OMS Mpower 2008.
- BackgroundObservatoire français des drogues et des toxicomanies. Les niveaux d'usage des drogues en France en 2010. OFDT Tendances, n°76, juin 2011
- Background: PubMed 16340832Le Faou AL, Scemama O. [Epidemiology of tobacco smoking]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S27-32. French.
- BackgroundHill C, Jougla E, Beck F. Le point sur l'épidémie de cancer du poumon dû au tabagisme. BEH mai 2010; 19-20: 210-213
- BackgroundFuxe, K., Anderson, K., Eneroth, P., 1987. Effects of nicotine and exposure to cigarette smoke on discrete dopamine and noradrenaline nerve terminal systems of the telcephalon and diencephalon of the rat: relationship to reward mechanisms and distribution of nicotine binding sites in brain. In: Martin, W.R., Van Loon, G.R., Iwamoto, E.T., et al. (Eds.), Tobacco Smoking and Nicotine: A Neurobiological Approach. Plenum, New York, pp. 225-262.
- BackgroundPert, A., Clarke, P.B.S., 1987. Nicotine modulation of dopaminergic transmission: functional implications. In: Martin, W.R., Van Loon, G.R., Iwamoto, E.T., et al. (Eds.), Tobacco, Smoking and Nicotine: A Neurobiological Approach. Plenum, New York, pp.169-189.
- BackgroundUnited States Department of Health and Human Services, 1988. The Health Consequences of Smoking: Nicotine Addiction. US Government Printing Office, Washington, DC DHHS Publication No.CDC-88-8406.
- BackgroundClarke, P., 1990. Mesolimbic dopaminergic activation: the key to nicotine reinforcement. In: Bock, G., Marsh, J. (Eds.), The Biology of Nicotine Dependence. Wiley, New York, pp. 153-168.
- Background: PubMed 8974398Pich EM, Pagliusi SR, Tessari M, Talabot-Ayer D, Hooft van Huijsduijnen R, Chiamulera C. Common neural substrates for the addictive properties of nicotine and cocaine. Science. 1997 Jan 3;275(5296):83-6. doi: 10.1126/science.275.5296.83.
- Background: PubMed 3317472Wise RA, Bozarth MA. A psychomotor stimulant theory of addiction. Psychol Rev. 1987 Oct;94(4):469-92. No abstract available.
- Background: PubMed 2065112Collins AC, Marks MJ. Progress towards the development of animal models of smoking-related behaviors. J Addict Dis. 1991;10(1-2):109-26. doi: 10.1300/J069v10n01_08.
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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.
Rose-Marie ROUQUET, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS procedure in people with Tobacco Use Disorder, run by University Hospital, Toulouse 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 7 inclusion and 9 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 24 Feb 2014. 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?
Relative change of individual salivary cotinine. (time frame: Outcome measure is assessed at Day1 and Day5). 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 NCT01930422, which also lists 77 linked publications.
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 24 Feb 2014.