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tDCS as Add on Therapy for Treatment of Tobacco Dependence by Standardized Behaviour Therapy

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ClinicalTrials.gov Identifier: NCT01729507
Recruitment Status : Unknown
Verified November 2012 by Andrea Linhardt, Ludwig-Maximilians - University of Munich.
Recruitment status was:  Recruiting
First Posted : November 20, 2012
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):
Andrea Linhardt, Ludwig-Maximilians - University of Munich

Brief Summary:

As an add-on treatment to behavioural therapy for tobacco dependence, anodal transcranial direct current stimulation (tDCS) significantly increases the cessation rate compared to treatment with sham tDCS; endpoint analysis will be performed 1, 3, 6 and 12 months after completion of the smoke-free programme in combination with tDCS.

Craving, assessed with a visual analog scale (VAS), is reduced significantly in the verum treatment group compared to the sham tDCS group.

tDCS is suitable for use in larger groups (8-12 people).


Condition or disease Intervention/treatment Phase
Smoking Cessation Tobacco Dependence Other: tDCS Behavioral: standardised behavioural therapy Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (TDCS) as Add on Therapy for Treatment of Tobacco Dependence by Standardized Behaviour Therapy - Active and Placebo Controlled Double Blind Study
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Arm Intervention/treatment
Active Comparator: Treatment with tDCS
This group will receive 7x verum treatment with tDSC. All participants receive standardised behavioural therapy ('The smoke-free programme')
Other: tDCS
Stimulation will be performed with a DC stimulator MC Location of stimulation: Anode over the left dorsolateral cortex, corresponding with F3 (in 10-20 EEG system); cathode over the right temporal cortex Intensity: 2 mA Total duration: Constant stimulation for 20 minutes
Other Name: Stimulator MC (neuroConn GmbH, Ilmenau, Germany).

Behavioral: standardised behavioural therapy

The standardised behavioural therapy will be performed according to the certified "Smoke-free programme' of the of the Institute for Therapy Research ('Institut für Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of participants is 8-12.

1 group session for 90 minutes/week for 7 weeks, 2 telephone calls of 10 minutes each, first after the fourth session 3 days after collective smoking cessation, second on day 3 after the last session.


Placebo Comparator: 7x sham treatment
This group will receive 7x sham treatment. All participants will receive standardised behavioural therapy ('The smoke-free programme')
Behavioral: standardised behavioural therapy

The standardised behavioural therapy will be performed according to the certified "Smoke-free programme' of the of the Institute for Therapy Research ('Institut für Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of participants is 8-12.

1 group session for 90 minutes/week for 7 weeks, 2 telephone calls of 10 minutes each, first after the fourth session 3 days after collective smoking cessation, second on day 3 after the last session.





Primary Outcome Measures :
  1. cessation rate [ Time Frame: at 4 weeks after last intervention ]
    salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.


Secondary Outcome Measures :
  1. Craving [ Time Frame: week one directly before first tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  2. Craving [ Time Frame: week two directly before second tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  3. Craving [ Time Frame: week three directly before third tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  4. Craving [ Time Frame: week four directly before fourth tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  5. Craving [ Time Frame: week five directly before fifth tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  6. Craving [ Time Frame: week six directly before sixth tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  7. Craving [ Time Frame: week seven directly before seventh tDCS intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  8. Craving [ Time Frame: four weeks after last intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.

  9. Craving [ Time Frame: twelve weeks after last intervention ]
    Craving, assessed with a visual analog scale (VAS)and Questionnaire on Smoking Urges (QSU), is reduced significantly in the verum treatment group compared to the sham tDCS group.


Other Outcome Measures:
  1. cessation rate [ Time Frame: at 12 weeks after last intervention ]
    salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age of legal majority
  • Smoker for > 1 year, >10 cigarettes/day
  • CO>10ppm; measurement in expired air by means of a Micro Smokerlyzer (Bedfont Scientific Ltd., Maidstone, England)
  • Quantification of tobacco dependence with the Fagerström Test
  • The patient should not have attempted to quit smoking or have received drug treatment for quitting smoking for at least 3 months before the start of the study
  • Ability to give informed consent

Exclusion Criteria:

  • Acute psychiatric disorders according to ISD-10/DSM-IV
  • Under legal care
  • Pregnancy
  • Contraceptive methods with a Pearl Index >1
  • Other severe psychiatric disorders
  • Acute suicidality
  • Drug, medication or alcohol abuse at the time of the study
  • Dementia (DSM-IV/ICD-10 criteria)
  • History of severe craniocerebral trauma
  • Indications of structural damage to the basal ganglia or the brain stem
  • Severe neurological disorders (such as prolapsed disk in the past 6 months, polyneuropathy, Parkinson syndrome, epilepsy, dementia, systemic neurological diseases, cerebrovascular diseases, history of stroke, repeated cerebral ischaemia with progressive worsening, elevated cerebral pressure, normal pressure hydrocephalus)
  • Severe medical disorders (such as manifest arterial hypertension, severe cardiovascular disorders, cardiac pacemaker, respiratory insufficiency)
  • Any electronic implants
  • Malignant diseases of any kind, also in the medical history
  • Severe active infectious diseases
  • Chronic and systemic skin diseases
  • Bone diseases (such as Paget's disease, osteoporosis with spontaneous fractures, fresh fractures)

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): NCT01729507


Locations
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Germany
Ludwig Maximilans University Recruiting
Munich, Bavaria, Germany, 80336
Contact: Andrea Linhardt    00498951605707    andrea.linhardt@med.uni-muenchen.de   
Sub-Investigator: Andrea Linhardt         
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Study Director: Frank Padberg, PD Dr. Department of Psychotherapy and Psychosomatic Medicine

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Responsible Party: Andrea Linhardt, physician, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01729507     History of Changes
Other Study ID Numbers: 489-11
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012
Keywords provided by Andrea Linhardt, Ludwig-Maximilians - University of Munich:
Smoking cessation
Add on and smoking cessation
Therapy for tobacco dependence
Transcranial direct current stimulation
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders