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

NCT01729507 | Unknown Phase 4

• 1 other identifier: 489-11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Smoking Cessation; Tobacco Dependence

Keywords

Smoking cessation; Add on and smoking cessation; Therapy for tobacco dependence; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• cessation rate

  salivary cotinine in ng/ml and the carbon monoxide content of expired air (COppm and %COHb)will be measured.

  at 4 weeks after last intervention

Secondary Outcomes (9)

• Craving

  week one directly before first tDCS intervention

• Craving

  week two directly before second tDCS intervention

• Craving

  week three directly before third tDCS intervention

• Craving

  week four directly before fourth tDCS intervention

• Craving

  week five directly before fifth tDCS intervention

Other Outcomes (1)

• cessation rate

  at 12 weeks after last intervention

Study Arms (2)

Treatment with tDCS

ACTIVE COMPARATOR

This group will receive 7x verum treatment with tDSC. All participants receive standardised behavioural therapy ('The smoke-free programme')

Other: tDCS; Behavioral: standardised behavioural therapy

7x sham treatment

PLACEBO COMPARATOR

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

Behavioral: standardised behavioural therapy

Interventions

tDCS OTHER

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

Also known as: Stimulator MC (neuroConn GmbH, Ilmenau, Germany).

Treatment with tDCS

standardised behavioural therapy BEHAVIORAL

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.

7x sham treatment; Treatment with tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Ludwig Maximilans University

Munich, Bavaria, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Frank Padberg, PD Dr.

  Department of Psychotherapy and Psychosomatic Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: November 20, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 27, 2012

Record last verified: 2012-11

Locations

DE (1)