Transcranial Direct Current Stimulation - Tobacco Use Disorder

NCT03691805 | Completed

• 1 other identifier: tDCS-TUD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Disorder

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• Reduced number of cigarettes smoked

  Smoking habits will be assessed via interview at the beginning of the study and after a follow-up period of three days. Number of cigarettes smoked will be compared longitudinally and between groups.

  First assessment on Day 1, second on Day 8

Secondary Outcomes (2)

• Reduced Carving

  First assessment on Day 1, second on Day 5, third on Day 8

• Increased inhibitory control

  First and second testing on Day 1, third testing on Day 5

Study Arms (2)

anodal tDCS over rDLPFC

ACTIVE COMPARATOR

Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC).

Device: tDCS

sham tDCS

SHAM COMPARATOR

Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC.

Device: Sham tDCS

Interventions

tDCS DEVICE

The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.

Also known as: sooma medical, transcranial direct current stimulation

anodal tDCS over rDLPFC

Sham tDCS DEVICE

The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.

sham 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:

• 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

You may not qualify if:

• withdrawal of the declaration of consent
• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Location

Related Publications (1)

• 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.

  PMID: 34198135 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

• Sabine Vollstädt-Klein

  ZI Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded as to their assigned study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: October 15, 2018
• Primary Completion: February 18, 2020
• Study Completion: February 18, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

DE (1)