SmokingNCT02590640
Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers
A study testing Repetitive transcranial magnetic stimulation, MagStim Rapid2 in people with Smoking, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Repetitive transcranial magnetic stimulation, MagStim Rapid2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 6 Sep 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-55
- Ability to provide informed consent
- Self-reported current average daily cigarette consumption >10/day for at least 1 year
- Self-reported motivation to quit smoking
Who cannot join
- MRI/TMS exclusions, including
- Claustrophobia
- Intracranial or spinal hardware
- Pacemakers
- MR-incompatible devices (Examples: pacemaker, deep brain stimulator, vagal nerve stimulator, cochlear implant, insulin pump, implanted medication pump, bone stimulator, implanted defibrillator)
- History of metal objects or fragments in the eye or skull, including shrapnel or metal plates
Show all 22Show fewer
- History of stroke or other brain lesion
- History of attempted suicide or suicidal ideation
- Personal history of headaches, seizures, epilepsy, or status epilepticus
- Family history of epilepsy
- Medications known to lower seizure threshold (e.g., tricyclic antidepressants, antipsychotics, psychostimulants)
- Increased intracranial pressure, hydrocephalus, or pseudotumor cerebri
- Unstable coronary artery disease
- Current pregnancy or positive urine pregnancy test
- Neurological illness
- Prior neurosurgery
- Schizophrenia
- Bipolar disorder
- Current (within the last two months) major depressive disorder
- Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or sedative on the day of testing
- Alcohol dependence or positive breath test for alcohol on the day of testing
- Use of tobacco products other than cigarettes.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Department of Radiology
Aurora, Colorado, 80045
About this study
The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.
For interested participants, this study requires a single 3 hour appointment, which will include MRI of the brain as well as TMS.
- Conditions
- Smoking
- Being tested
- Repetitive transcranial magnetic stimulation, MagStim Rapid2, Sham repetitive transcranial magnetic stimulation
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation, MagStim Rapid2Device
This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.
Sham repetitive transcranial magnetic stimulationDevice
Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
| Study group | Role | What they receive |
|---|---|---|
| Inhibitory insular rTMS | Active comparator | Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Receives: Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2 |
| Sham insular rTMS | Sham comparator | Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ
Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)
Measured: 1 hour
Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
Measured: 1 hour
Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
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 SmokingStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael F Regner, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590640
- Sponsor's protocol ID
- 15-1016
- Status last verified
- Jun 2022
- First submitted
- 26 Oct 2015
- Last updated
- 13 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers
- ClinicalTrials.gov ID
- NCT02590640
- Acronym / sponsor ID
- 15-1016
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.
For interested participants, this study requires a single 3 hour appointment, which will include MRI of the brain as well as TMS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibitory insular rTMS | Active comparator | Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
| Sham insular rTMS | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-55
- Ability to provide informed consent
- Self-reported current average daily cigarette consumption >10/day for at least 1 year
- Self-reported motivation to quit smoking
Key exclusion criteria (22 listed)
- MRI/TMS exclusions, including
- Neurological illness
- Prior neurosurgery
- Schizophrenia
- Bipolar 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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation, MagStim Rapid2This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain. | Device | Inhibitory insular rTMS |
| Sham repetitive transcranial magnetic stimulationSham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. | Device | Sham insular rTMS |
Primary outcome
Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ
Time frame: 1 hour
Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)
Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
Time frame: 1 hour
Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- 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.
Michael F Regner, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation, MagStim Rapid2 in people with Smoking, run by University of Colorado, Denver 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 4 inclusion and 22 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 13 Jul 2022. 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 13 Jul 2022). 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?
Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 13 Jul 2022.