Tobacco Use DisorderNCT03691805
Transcranial Direct Current Stimulation - Tobacco Use Disorder
A study testing tDCS in people with Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2018to 18 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim
About this study
Official title: Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving
This study aims to detect how transcranial direct current stimulation (tDCS) affects smokers' inhibitory control, craving and consumption of tobacco goods.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- tDCS, Sham tDCS
- Keywords
- Transcranial Direct Current Stimulation
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called sooma medical, transcranial direct current stimulation
The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
Sham tDCSDevice
The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS over rDLPFC | Active comparator | Participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC). Receives: Device: tDCS |
| sham tDCS | Sham comparator | Participants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First assessment on Day 1, second on Day 8
Secondary outcomes (2)
Reduced Carving
Craving will be assessed using visual analog scales on the first and fifth day of the study as well as in the follow-up interview. Ratings will be compared longitudinally and between groups..
Measured: First assessment on Day 1, second on Day 5, third on Day 8
Increased inhibitory control
Inhibitory control will be assessed in neuropsychological tests (Go / No-Go, Stop-Signal Task) before and after the first stimulation session and after the fifth session. Results will be compared longitudinally and between groups.
Measured: First and second testing on Day 1, third testing on Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start15 Oct 2018
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstädt-Klein, Principal investigator, ZI Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691805
- Sponsor's protocol ID
- tDCS-TUD
- Status last verified
- Dec 2020
- First submitted
- 28 Sep 2018
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34198135
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation as an Intervention in Tobacco Use Disorder: Effects on Consumption and Craving
- ClinicalTrials.gov ID
- NCT03691805
- Acronym / sponsor ID
- tDCS-TUD
- Conditions
- Tobacco Use Disorder
- Keywords
- Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Half of the participants will receive transcranial direct current stimulation, while the others will receive sham stimulation.
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS over rDLPFC | Active comparator | Device: tDCSParticipants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal Cortex (DLPFC). |
| sham tDCS | Sham comparator | Device: Sham tDCSParticipants will receive sham tDCS (transcranial direct current stimulation) of the DLPFC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: sooma medical, transcranial direct current stimulationThe participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days. | Device | anodal tDCS over rDLPFC |
| Sham tDCSThe participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days. | Device | sham tDCS |
Primary outcome
Reduced number of cigarettes smoked
Time frame: First assessment on Day 1, second on Day 8
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.
2 secondary outcomes
Reduced Carving
Time frame: First assessment on Day 1, second on Day 5, third on Day 8
Increased inhibitory control
Time frame: First and second testing on Day 1, third testing on Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Derived from this study: PubMed 34198135Muller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Vollstädt-Klein principal investigator
ZI Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Tobacco Use Disorder, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced number of cigarettes smoked (time frame: First assessment on Day 1, second on Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.