Neurocircuit Strategy to Decrease Cocaine Cue Reactivity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)
研究概览
简要总结
The overarching goal of this project is to examine the effect of combining theta burst stimulation (TBS) and N-acetylcysteine (NAC) on cocaine craving and brain response to cocaine-related images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Age 18-65
- •English fluency
- •Meet criteria for cocaine use disorder (CUD), as determined by DSM-V criteria, using the Structured Clinical Interview for DSM-V.
- •5. Enrolled in an intensive outpatient treatment program (MUSC Center for Drug and Alcohol Programs Intensive Outpatient Program (CDAP-IOP) or currently engaged in treatment for substance related problems.
- •6. Able to read and understand questionnaires and informed consent
- •Lives within 50 miles of the study site.
- •Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
- •Does not have metal objects in the head/neck.
- •Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
- •11. Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
排除标准
- •Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
- •Any physical or intellectual disability affecting completion of assessments
- •Any contraindication to MRI
- •Current or past psychosis
- •ECT in last 6 months
- •Among females, pregnancy at screening will be exclusionary. Females of child bearing potential must agree to undergo a pregnancy test 72 hours prior to the fMRI scanning session and regularly before and during the medication trial. They must further agree to notify the study physician or PA if they become pregnant during the study.
- •Clinical Institute Withdrawal Assessment (CIWA-Ar) scale will be used to assess alcohol withdrawal. Individuals with CIWA > 8 will be excluded.
- •Individuals with unstable medical illness (e.g., hypertension, diabetes, myocardial infarction)
- •Has current suicidal ideation or homicidal ideation.
- •Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD
- •Suffers from chronic migraines
- •Any physical or intellectual disability affecting completion of assessments
研究组 & 干预措施
N-acetylcysteine + Theta Burst Stimulation
干预措施: Theta-burst stimulation (TBS) (Device)
N-acetylcysteine + Theta Burst Stimulation
干预措施: N-acetylcysteine (Drug)
N-acetylcysteine + Sham Theta Burst Stimulation
干预措施: N-acetylcysteine (Drug)
Placebo + Theta Burst Stimulation
干预措施: Theta-burst stimulation (TBS) (Device)
结局指标
主要结局
Change in Orbitofrontal Cortex (OFC) BOLD Signal During Cocaine Cue Reactivity Task (Pre- vs. Post-TBS)
时间窗: From baseline to immediately post-TBS
Measured using fMRI during cocaine cue reactivity task. Percent BOLD signal change in OFC from baseline (Visit 2) to post-TBS (Visit 3). Measured using functional MRI during a cocaine cue reactivity task. The outcome reflects the change in raw BOLD signal in the orbitofrontal cortex (OFC) between baseline and post-TBS sessions. Signal change was calculated by comparing activation during cocaine-related image blocks versus neutral image blocks. Values are reported as raw BOLD signal units (not percentages).
Change in POMS Score From Baseline to Post-TBS"
时间窗: From baseline to immediately post-TBS
Total POMS score measured before and after TBS. Higher scores indicate worse mood.
Change in Cocaine Craving Rating From Baseline to Post-TBS
时间窗: From baseline to immediately post-TBS
Self-reported craving measured using NRS (1-10) before and after TBS. Higher scores indicate greater craving.
次要结局
未报告次要终点