NCT03711318终止3 期
Buprenorphine Stabilization and Induction Onto Vivitrol for Heroin-dependent Individuals
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
研究概览
简要总结
A short-term treatment with buprenorphine prior to initiating treatment with naltrexone may increase the proportion of heroin-dependent patients successfully inducted onto Vivitrol.
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
- 是
入选标准
- •Individuals between the ages of 18-60
- •Meets DSM-5 criteria of current opioid use disorder with six consecutive months of reported heroin use, supported by a positive urine for opiates indicating regular use of heroin
- •Seeking treatment for opioid use disorder with Vivitrol
- •Capable of giving informed consent and complying with study procedures
- •In otherwise good health based on complete medical history and physical examination, laboratory tests, and EKG
- •BMI between 18-40
排除标准
- •Reported treatment with methadone in the last 3 months or positive urine toxicology for methadone on the day of consent
- •Maintenance on, or regular use of buprenorphine or other prescription opioids
- •Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
- •Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS (CD4 count under 200 currently or medically ill with an opportunistic infection), unstable diabetes, cardiovascular disease.
- •Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year.
- •Physiologically dependent on alcohol or sedative- hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.
- •History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
- •Chronic neurocognitive disorder
- •History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
- •Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications
- •Fentanyl only use, supported by a urine toxicology that is positive for fentanyl only and negative for all other opioids.
- •Court mandated to treatment
研究组 & 干预措施
Short-term treatment with buprenorphine
Experimental
Short-term treatment with buprenorphine
干预措施: Buprenorphine/naloxone (Drug)
结局指标
主要结局
Proportion of Heroin-dependent Patients Successfully Inducted Onto Vivitrol
时间窗: 12 weeks
Number of patients who received the first Vivitrol injection among those who initiated the induction
次要结局
未报告次要终点
研究者
Adam Bisaga
Professor of Psychiatry
New York State Psychiatric Institute
研究点 (1)
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