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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30CA177558-10 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.
The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general population. These extraordinary smoking rates are associated with greater AIDS-related morbidity, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and outcome of HIV disease and has been identified as the leading contributor to premature mortality in PLWHA. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBS (Theta burst stimulation) | Active Comparator | Four sessions of TBS in one day |
|
| Sham TMS | Placebo Comparator | Four sessions of sham TMS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBS | Device | Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Gaze Fixation on Smoking Cues | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome | On Day 1 of the study |
| Gaze Fixation on Smoking Cues | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome | On Day 1 of the study after intervention |
| Craving for Cigarettes | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher. | On day one of the study. |
| Craving for Cigarettes | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher. | Immediately after intervention (sessions of TBS or sham TMS) on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Showing Functional Connectivity Changes | Changes in functional connectivity on a functional MRI brain scan. | on Day 1 of study |
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Inclusion Criteria: Potential participants will be
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 245 Fountain Court | Lexington | Kentucky | 40513 | United States | ||
| University of Kentucky |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37693107 | Derived | Rakesh G, Alcorn JL 3rd, Khanal R, Himelhoch SS, Rush CR. Comparing cigarette-cue attentional bias between people with HIV/AIDS and people with opioid use disorder who smoke. Health Psychol Behav Med. 2023 Sep 7;11(1):2255028. doi: 10.1080/21642850.2023.2255028. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TBS (Theta Burst Stimulation) | Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan. |
| FG001 | Sham TMS | Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TBS (Theta Burst Stimulation) | Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Gaze Fixation on Smoking Cues | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome | Posted | Mean | Standard Deviation | milliseconds | On Day 1 of the study |
|
6 months
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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 | TBS (Theta Burst Stimulation) | Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gopalkumar Rakesh MD | University of Kentucky, Lexington | 859-257-9402 | gopalkumar.rakesh@uky.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 | Jun 11, 2025 | Aug 1, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 18, 2024 | Aug 21, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Active group and sham group
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Participant will not know whether they receive active or sham TMS
| Sham TMS | Device | Four sessions of sham TMS delivered using MagVenture B65 A/P coil. |
|
| Lexington |
| Kentucky |
| 40513 |
| United States |
| Sham TMS |
Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Gaze Fixation on Smoking Cues | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome | Posted | Mean | Standard Deviation | milliseconds | On Day 1 of the study after intervention |
|
|
|
| Primary | Craving for Cigarettes | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher. | Posted | Mean | Standard Deviation | units on a scale | On day one of the study. |
|
|
|
| Primary | Craving for Cigarettes | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher. | Posted | Mean | Standard Deviation | units on a scale | Immediately after intervention (sessions of TBS or sham TMS) on day 1 |
|
|
|
| Secondary | Number of Participants Showing Functional Connectivity Changes | Changes in functional connectivity on a functional MRI brain scan. | Posted | Count of Participants | Participants | on Day 1 of study |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Sham TMS | Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |