Direct Transcranial Electrical Stimulation in Tobacco Addiction (tDCS)

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04209153
Collaborator
(none)
100
1
42
2.4

Study Details

Study Description

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 Phase
  • Other: Transcranial Direct Current Stimulation

Study Design

Study Type:
Observational
Anticipated 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
Actual Study Start Date :
Nov 29, 2021
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
May 29, 2025

Outcome Measures

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) [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 [15 days]

    Evaluation of changes in tobacco consumption and smoking craving intensity and tolerance of tDCS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiatrie Adultes Et Addictologie Paris IDF France 75006

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04209153
Other Study ID Numbers:
  • APHP190731
  • 2019-A01946-51
First Posted:
Dec 23, 2019
Last Update Posted:
Dec 7, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 7, 2021