Imaging Biomarker for Addiction Treatment Outcome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- For cross-sectional study will be differences in functional connectivity and BOLD signal activation in executive and impulsive neurobehavioral decision systems at various stages of sobriety in relation to controls
研究概览
简要总结
Background:
Many people suffer from drug addiction. But currently, treatments are not very effective. One group of patients in this study are enrolled in addiction treatment through physician health programs (PHPs). About 70% of these patients are able to stop using drugs for extended periods of time. By studying this specific group of patients, researchers want to understand the difference between those who may or may not respond to treatment. They want to study the brain while people do thinking and feeling tasks and when they relax. They will study brain chemicals, a stress hormone, and certain genes. The results may help them understand the brain basis for addiction and recovery.
Objectives:
To use brain imaging to find differences between people with and without drug addiction. To see if these differences help predict addiction.
Eligibility:
Healthy, right-handed adults ages 21-65, enrolled in a physician health program or those with no history of addiction and with at least 16 years of education
Design:
Participants enrolled in a PHP will be screened under this study and participants with no history of addiction will be screened under another study.
At the study visit, participants will:
Have a routine check-up, including tests for pregnancy, drugs, and alcohol.
Give 11 blood samples.
Rate their cravings.
Test their frustration with stressful situations by responding to questions on a screen.
Practice the magnetic resonance imaging (MRI) tasks:
Shock task. Two electrodes placed on a foot will deliver brief, low-strength electrical shocks that get gradually stronger, but not painful. Participants will see drug or neutral images. They will rate their discomfort.
Thinking tasks. Participants will answer questions about pictures, numbers, and money. They will press buttons in response to things they see.
Do the MRI tasks in 2 sessions (morning and afternoon) in the scanner. Participants will lie in an MRI machine which will take pictures of the brain while doing these tasks.
Some participants will repeat the visit twice over a year at set intervals.
Meals will be provided, and visits will include meal breaks and smoking breaks for those who smoke.
详细描述
Objective:
Despite recent advances in addiction neuroscience, achieving a breakthrough in predicting addiction treatment outcome has been difficult and long-term abstinence success unacceptably low. The aim of this study is to create a biomarker using various neuroimaging metrics that can predict treatment outcome in opioid, alcohol and dual opioid and alcohol use disorder patients.
Study Population:
Total study enrollment will include up to 650 participants. The main study population will include up to five hundred (500) participants to reach three hundred fifty (350) completers (50 per group) based on their addiction status (1) healthy, non-drug using control participants (CON) (2) Early-in-treatment, healthy prescription opioid use disorder participants currently enrolled in physician health program (PHP) within 3 months of starting treatment (POUD-E), (3) Long-term-in-treatment, healthy prescription opioid use disorder participants currently enrolled in or affiliated with a PHP more than 2 months (POUD-L), (4) Early-in-treatment, healthy alcohol use disorder participants currently enrolled in PHP within 3 months of starting treatment (AUD-E), (5) Long-term-in-treatment, healthy alcohol use disorder participants currently enrolled in or affiliated with a PHP more than 2 months (AUD-L), (6) Early-in-treatment, healthy dual prescription opioid and alcohol and use disorder participants currently enrolled in PHP within 3 months of starting treatment (POAUD-E), (7) Long-term-in-treatment, healthy dual prescription opioid and alcohol use disorder participants currently enrolled in or affiliated with a PHP more than 2 months (POAUD-L). The Addiction Phenotype Characterization arm will include up to 150 completers.
Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
For cross-sectional study will be differences in functional connectivity and BOLD signal activation in executive and impulsive neurobehavioral decision systems at various stages of sobriety in relation to controls
时间窗: 1 study visit
For cross-sectional study will be differences in functional connectivity and BOLD signal activation in executive and impulsive neurobehavioral decision systems at various stages of sobriety in relation to controls
For the longitudinal study will be differences in baseline and changes over time in functional connectivity circuits, BOLD signal activation in executive and impulsive neurobehavioral decision systems between abstinent and relapsing addicts that...
时间窗: 6 & 12 mo f/u visits
For the longitudinal study will be differences in baseline and changes over time in functional connectivity circuits, BOLD signal activation in executive and impulsive neurobehavioral decision systems between abstinent and relapsing addicts that can predict treatment response at 6 and 12 months.
For the Addiction Phenotype Characterization arm: characterization measures
时间窗: at completion of characterization measures
The outcome measures for the Addiction Phenotype Characterization arm are phenotypic factors that are related to addiction as measured by the psychiatric interview, drug use history assessments, and self-administered questionnaires to characterize clinical phenotype and physical condition.
次要结局
- Phenotypic (performance on behavioral tasks, self-reported measures of cravings, impulsivity and personality traits), genotypic and imaging (structural and spectroscopy) differences between different addiction groups.(At each visit)