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Transcranial Direct Current Stimulation - Tobacco Use Disorder

NCT ID: NCT03691805

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2020-02-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Tobacco Use Disorder

Keywords

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Transcranial Direct Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be blinded as to their assigned study arm.

Study Groups

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anodal tDCS over rDLPFC

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

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type DEVICE

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

sham tDCS

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

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

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

Interventions

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tDCS

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

Intervention Type DEVICE

Sham tDCS

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

Intervention Type DEVICE

Other Intervention Names

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sooma medical transcranial direct current stimulation

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Vollstädt-Klein

Role: PRINCIPAL_INVESTIGATOR

ZI Mannheim

Locations

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Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 34198135 (View on PubMed)

Other Identifiers

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tDCS-TUD

Identifier Type: -

Identifier Source: org_study_id