Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Gaze Fixation on Smoking Cues
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant will not know whether they receive active or sham TMS
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Potential participants will be
- •Patients enrolled in the Bluegrass Clinic
- •18-60 years of age
- •Male or female gender
- •Able to read, understand and communicate in English
- •Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic
- •Willing and able to abstain from drug use other than Suboxone
- •Exhaled breath on day of study carbon monoxide (CO) < 5 ppm
- •Stabilized on maintenance buprenorphine if having comorbid opioid use disorder.
排除标准
- •Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel.
- •Previous adverse effect with TMS.
- •Sub-threshold consistency while performing behavioral tasks.
- •Failure to show baseline attentional bias to smoking versus neutral cues.
结局指标
主要结局
Gaze Fixation on Smoking Cues
时间窗: On Day 1 of the study after intervention
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Gaze Fixation on Smoking Cues
时间窗: On Day 1 of the study after intervention
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Craving for Cigarettes
时间窗: Immediately after intervention (sessions of TBS or sham TMS) on day 1
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.
次要结局
- Number of Participants Showing Functional Connectivity Changes(on Day 1 of study)
研究者
Gopalkumar Rakesh
Assistant Professor
University of Kentucky