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Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS) (tDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209153
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
In summary, there are currently many therapeutic tools for achieving some degree of control or even cessation of tobacco addictive use. No single therapy seems to have proven itself sufficiently effective to be the preferred treatment axis in the management of this addiction. We can also point out that so far the main treatments aimed at reducing or controlling the craving phenomenon are of a pharmacological nature, thus exposing the participants to the side effects inherent to this type of treatment. In this perspective, the establishment of non invasive brain stimulation (TdCS), acting in a targeted manner on craving and whose effects would be mild and transient, appears quite justified, especially in addition to psychotherapy. In the context of the management of addictive pathologies, the choice of smoking dependence seems relevant to us insofar as this addiction represents a major public health problem.

Condition or disease Intervention/treatment
Adults (Male and Female Subjects) With Tobacco Dependence Other: Transcranial Direct Current Stimulation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Effect of Transcranial Direct Current Stimulation (tDCS) in Nicotine-Dependent Tobacco Users
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 1, 2023

Intervention Details:
  • Other: Transcranial Direct Current Stimulation
    tDCS sessions (with Direct Transcranial Electrical Stimulation (tDCS) device - Neuroelectrics


Primary Outcome Measures :
  1. Fagerström score (3 is the highest score and O the lowest one for item 1. A score of 1 or 2 means low dependence (for item 1 only as well as if you use the total score) [ Time Frame: 15 days ]
    average difference in Fagerström score 1 scores that assess craving for tobacco between pre-treatment assessment (J0) and short-term post-treatment evaluations (J15).


Secondary Outcome Measures :
  1. tobacco consumption [ Time Frame: 15 days ]
    Evaluation of changes in tobacco consumption and smoking craving intensity and tolerance of tDCS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All tobacco smokers who will ask for consultation in our ward.
Criteria

Inclusion Criteria:

  • Men and women over the age of 18
  • Nicotine dependent subjects according to the Fagerström test (score ≥5)
  • Subjects consuming daily tobacco.
  • Subjects understanding and reading French and able to express themselves in this language.
  • Signed informed consent to participate indicating that the subject has understood the purpose and the procedures required by the study and agrees to participate in the study and to comply with the requirements and limitations of this study
  • Affiliation to the French social security scheme or beneficiary of such a scheme.
  • No other method to decrease or stop smoking at the same time as the study.

Exclusion Criteria:

  • Guardianship
  • Pregnant or lactating woman
  • Patient under AME
  • Subject being in the exclusion period of another study or provided for by the "National Volunteer File".
  • Subjects with intracranial hypertension
  • Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator.
  • Treatment with buproprion or varenicline in progress
  • Episode or family history of epilepsy, convulsion.
  • Disease causing damage to the brain (aneurysm, tumor, ...).
  • Cochlear or ocular implant.
  • Stimulator or cardiac defibrillator.
  • Presence of metal in the skull (clip on aneurysm, prosthesis, ...).
  • Eczema on the scalp.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209153


Contacts
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Contact: Florence THIBAUT, PHD (33) 1 58 41 16 79 florence.thibaut@aphp.fr
Contact: Caroline TOURTE (33) 1 58 41 11 90 caroline.tourte@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04209153    
Other Study ID Numbers: APHP190731
2019-A01946-51 ( Other Identifier: IDRCB )
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Tobacco
addiction
transcranial non invasive direct brain stimulation
adults
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders