CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery - Prescription Opiates/Medication
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Illicit-positive Urines During Treatment and Follow-up
研究概览
简要总结
The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign an informed consent form;
- •Be between the ages of 18 and 60;
- •Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI);
- •Be in good general health as determined by complete physical examination and laboratory tests;
- •Have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal.
排除标准
- •Current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
- •Current psychosis, dementia, mental retardation, or history of schizophrenia;
- •Significant clinical abnormalities in hematology, chemistry, or urinalysis;
- •Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
- •Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestrel implant); (Pregnancy testing will be done on all females of child bearing age); and
- •Current diagnosis of chronic pain disorder.
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: Vivitrol (Drug)
结局指标
主要结局
Illicit-positive Urines During Treatment and Follow-up
时间窗: three months
次要结局
未报告次要终点