Biomarkers of Disease and Response to Treatment in Opioid Addiction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Brain response to heroin-related visual cues
研究概览
简要总结
This study evaluates the biological markers of treatment of opioid dependent individuals with an extended release formulation of the opioid antagonist naltrexone. The biological measures include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and behavioral tests probing various aspects of personality, memory, reward processing and attention.
详细描述
This study is using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) to examine the brain predictors of adherence and outcomes of opioid antagonist therapy. Opioid-dependent intravenous heroin users are offered up to 3 monthly injections of the extended-release naltrexone (XRNTX) contingent upon successful outpatient non-opioid detoxification, with an additional 4 weeks of follow up. Brain responses to heroin-related pictures are recorded using fMRI prior to the 1st XRNTX injection and approximately 2 weeks thereafter the 1st XRNTX injection. Primary clinical variables include the number of injections (maximum of 3) accepted by participants, change in self-reported craving for opioids after exposure to drug-related visual cues during the brain fMRI sessions, urine levels of ten commonly abused substances and self-report of cigarette use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV-TR diagnosis of opioid dependence, active opioid use, confirmed by urine toxicology screen and self-reported monthly intravenous heroin use for more than 2 weeks in the past 3 months
- •urine toxicology screen negative for opioids after detoxification
- •good physical health as indicated by history and physical examination, screening blood work-up and urinalysis.
排除标准
- •chronic medical illnesses;
- •current use of medications potentially confounding brain activity, such as anti-dopaminergic agents, anti-depressants and beta-blockers;
- •current DSM-IV-TR Axis I psychiatric disorders other than opioid and nicotine dependence;
- •life time history of concurrent IV cocaine and heroin (speedball) administration;
- •pregnancy or breastfeeding;
- •history of clinically significant head trauma;
- •contraindications for naltrexone treatment including medical conditions requiring opioid analgesics, e.g. chronic pain or planned surgery, obesity, elevated liver enzymes (> 3 times upper limit of normal), failure to complete opioid detoxification
- •contraindications for MRI, i.e. indwelling magnetically active foreign bodies and phobia to enclosed spaces
研究组 & 干预措施
Naltrexone Intervention
Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks.
干预措施: Naltrexone (Drug)
结局指标
主要结局
Brain response to heroin-related visual cues
时间窗: 1 hour
Brain, behavioral and motivational (e.g. craving) response to audiovisual drug-related and control stimuli (images, smells and sounds) and to standard tasks of decision making, self-appraisal, response inhibition, social interaction and reward processing.
次要结局
- Cigarettes smoked per day(6 months)
- Urine toxicology(6 months)
- Injections(3 months)
- Motivational response to opioid-related visual cues measured by self-reported craving for opioids(2 hours)