Clinical trial NCT03691805: Transcranial Direct Current Stimulation - Tobacco Use Disorder
Official title: Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Transcranial Direct Current Stimulation
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
Primary purpose: TREATMENT

Brief summary: This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.

Detailed description: Participating smokers are to receive anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex (rDLPFC) for 20 minutes on five consecutive days. Neuropsychological tests on inhibitory control and interviews on smoking habits and craving will be applied before and after the first stimulation as well as after the fifth stimulation.

After a follow-up period of three days, smoking behaviour will be assessed in a telephone interview.

Changes in inhibitory control and smoking behaviour will be compared between an active and a sham stimulation group.This way the effects of transcranial direct current stimulation on tobacco use disorder are to be clarified.

Eligibility criteria: Inclusion Criteria:

* tobacco use disorder
* normal or correctable eyesight
* sufficient ability to communicate with the investigators, to answer questions in oral and written form
* fully informed consent
* written informed consent

Exclusion Criteria:

* withdrawal of the declaration of consent
* exclusion criteria for tDCS (metal implants in the head, acute eczema, known epilepsy)
* severe internal, neurological or psychiatric comorbidity
* pharmacotherapy with psychoactive substances within the last 14 days
* axis-I disorder according to ICD-10 and DSM 5 (except tobacco use disorder)
* positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
* pregnancy

Primary outcomes:
measure: Reduced number of cigarettes smoked
timeFrame: First assessment on Day 1, second on Day 8
Secondary outcomes:
measure: Reduced Carving
timeFrame: First assessment on Day 1, second on Day 5, third on Day 8
measure: Increased inhibitory control
timeFrame: First and second testing on Day 1, third testing on Day 5
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Study officials:
affiliation: ZI Mannheim
name: Sabine Vollstädt-Klein
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller T, Shevchenko Y, Gerhardt S, Kiefer F, Vollstadt-Klein S. The influence of perceived stress and self-control on efficacy of repeated transcranial direct current stimulation in non-treatment-seeking smokers. Drug Alcohol Depend. 2021 Sep 1;226:108861. doi: 10.1016/j.drugalcdep.2021.108861. Epub 2021 Jun 24.