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
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- cessation rate
研究概览
简要总结
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).
详细描述
- General design and study population
Controlled, randomised, double-blind study with no crossover; sample size estimate: 20-36 participants.
Sample size calculations are not necessary for pilot studies. A general 'rule of thumb' is to use 30 or more patients.
An interim analysis of the data will be performed after completion of the second course (stimulation of 24 patients). We reserve the right to increase the sample size by 12-24, depending on the effect size, so that we have data from 30 participants per arm and the estimate is reliable.
Study participants will be recruited via newspaper advertisements, advertisements on the internet page of the tobacco outpatient clinic and announcements on notice boards in the Department of Psychiatry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Treatment with tDCS
This group will receive 7x verum treatment with tDSC. All participants receive standardised behavioural therapy ('The smoke-free programme')
干预措施: tDCS (Other)
Treatment with tDCS
This group will receive 7x verum treatment with tDSC. All participants receive standardised behavioural therapy ('The smoke-free programme')
干预措施: standardised behavioural therapy (Behavioral)
7x sham treatment
This group will receive 7x sham treatment. All participants will receive standardised behavioural therapy ('The smoke-free programme')
干预措施: standardised behavioural therapy (Behavioral)
结局指标
主要结局
cessation rate
时间窗: 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.
次要结局
- Craving(twelve weeks after last intervention)
- 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)
- Craving(week six directly before sixth tDCS intervention)
- Craving(week seven directly before seventh tDCS intervention)
- Craving(four weeks after last intervention)
研究者
Andrea Linhardt
physician
Ludwig-Maximilians - University of Munich