Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 2
- 主要终点
- Opioid Use at 6 Month Follow-up
研究概览
简要总结
The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).
详细描述
This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype;
- •Within 3 days of admission to MMTC;
- •Age between 15 and 21, inclusive;
- •Able and willing to provide informed consent to be randomly assigned to XR- NTX or TAU; and for participants under 18 years of age, parental or guardian consent and participant assent.
排除标准
- •Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times greater than normal;
- •Unstable medical or psychiatric illness (e.g., schizophrenia) that might make participation hazardous;
- •History of serious suicide attempt in the past 6 months;
- •History of allergic reaction to naloxone, and/or naltrexone;
- •Current chronic pain condition for which opioids are deemed necessary for ongoing care;
- •blood coagulation disorder (e.g., hemophilia);
- •Body Mass Index > 40;
- •If female, pregnant, lactating, unwilling or unable (due to parental objection) to use FDA-approved contraceptive methods;
- •meeting DSM-IV criteria for benzodiazepine dependence
研究组 & 干预措施
Extended Release Naltrexone
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
干预措施: Extended Release Naltrexone (Drug)
Extended Release Naltrexone
Participants randomly assigned to XR-NTX who do not have opioid withdrawal signs or symptoms within 4 hours of administration of the 25 mg oral dose naltrexone will be given an intramuscular injection of XR-NTX [Vivitrol®] at a dose of 4cc (380mg of naltrexone)] and will subsequently have the same dose administered to alternating sides of the buttocks every four weeks for up to 6 months. All participants will also receive psychosocial treatment.
干预措施: Psychosocial Treatment (Behavioral)
Treatment as Usual
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
干预措施: Psychosocial Treatment (Behavioral)
Treatment as Usual
Participants randomly assigned to TAU will participate in the standard youth opioid program at the treatment center which includes either buprenorphine taper or ongoing buprenorphine treatment during the 6 months of the study for as long as they and their physicians think is appropriate. The general target dose will be 12-20 mg buprenorphine per day. All participants in TAU will receive psychosocial treatment.
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Opioid Use at 6 Month Follow-up
时间窗: 6 months
To determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of opioid use at 6-months post-treatment entry.
次要结局
- Treatment Retention(6 months)
- Monetized Healthcare Utilization(6 months)
- HIV Sex Risk Behaviors(6 months)