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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhibitory insular rTMS | Active Comparator | Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
|
| Sham insular rTMS | Sham Comparator | Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation, MagStim Rapid2 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
| Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping | 1 hour | |
| Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
MRI/TMS exclusions, including
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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael F Regner, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Department of Radiology | Aurora | Colorado | 80045 | United States |
Arms cannot be reported separately. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Inhibitory insular rTMS group: Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Repetitive transcranial magnetic stimulation, MagStim Rapid2: And Sham insular rTMS group: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Arms cannot be reported separately. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Inhibitory insular rTMS group: Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Repetitive transcranial magnetic stimulation, MagStim Rapid2: And Sham insular rTMS group: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable. | Posted | 1 hour |
|
1 day
Arms cannot be reported separately, nor can data be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Inhibitory insular rTMS group: Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Repetitive transcranial magnetic stimulation, MagStim Rapid2: And Sham insular rTMS group: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
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Data for this study was found to have been compromised. The P.I. responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable and cannot be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Research Services | University of Colorado Denver | Anschutz | 303-724-1111 | clinicalresearchsupportcenter@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2018 | Jun 21, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| Sham repetitive transcranial magnetic stimulation | Device | Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Sham Insular rTMS | Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Sham repetitive transcranial magnetic stimulation: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. |
|
| Primary | Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping | Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable. | Posted | 1 hour |
|
|
| Primary | Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping | Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable. | Posted | 1 hour |
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