Tobacco Use DisorderNCT03386253
Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
A study testing active tDCS in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
Trial summary
In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 and 64
- Smoked (on average) at least 5 cigarettes per day
- Be motivated to quit smoking
Who cannot join
- Unstable medical or psychiatric conditions
- Any medical conditions with neurological sequelae
- History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
- Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
- Are pregnant or planning to become pregnant during the study
- Current use of pacemaker, intracranial electrodes or implanted defibrillator
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Sciences Institute
Minneapolis, Minnesota, 55455
About this study
In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.
- Conditions
- Tobacco Use Disorder
- Being tested
- active tDCS, sham tDCS
- 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.
active tDCSDevice
two 13 minute tDCS sessions separated by 20 minutes in between
sham tDCSDevice
sham tDCS session given for same length of time as active
| Study group | Role | What they receive |
|---|---|---|
| active tDCS | Experimental | Participants receive active tDCS for five consecutive days before attempting to quit smoking Receives: Device: active tDCS |
| sham tDCS | Sham comparator | Participants receive sham tDCS for five consecutive days before attempting to quit smoking Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Willing to Complete 5 Days of tDCS or Sham
As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed.
Measured: 5 days
Secondary outcomes (1)
Change in Number of Cigarettes Smoked Per Day
Change in number of cigarettes smoked per day from the 1 week training period to the 4 week post quit period.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Jan 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386253
- Sponsor's protocol ID
- STUDY00000789
- Status last verified
- May 2022
- First submitted
- 22 Nov 2017
- Last updated
- 6 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors
- ClinicalTrials.gov ID
- NCT03386253
- Acronym / sponsor ID
- STUDY00000789
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 6 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tDCS | Experimental | Device: active tDCSParticipants receive active tDCS for five consecutive days before attempting to quit smoking |
| sham tDCS | Sham comparator | Device: sham tDCSParticipants receive sham tDCS for five consecutive days before attempting to quit smoking |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be between the ages of 18 and 64
- Smoked (on average) at least 5 cigarettes per day
- Be motivated to quit smoking
Key exclusion criteria (6 listed)
- Unstable medical or psychiatric conditions
- Any medical conditions with neurological sequelae
- History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
- Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
- Are pregnant or planning to become pregnant during the study
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 |
|---|---|---|
| active tDCStwo 13 minute tDCS sessions separated by 20 minutes in between | Device | active tDCS |
| sham tDCSsham tDCS session given for same length of time as active | Device | sham tDCS |
Primary outcome
Number of Participants Willing to Complete 5 Days of tDCS or Sham
Time frame: 5 days
As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed.
1 secondary outcome
Change in Number of Cigarettes Smoked Per Day
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active tDCS in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.
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 3 inclusion and 6 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 6 Mar 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Willing to Complete 5 Days of tDCS or Sham (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2023.