A Two-Phase Randomized Controlled Clinical Trial of Buprenorphine/Naloxone Treatment Plus Standard Medical Management or Enhanced Medical Management for Opioid Analgesic Dependence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 12
- 主要终点
- The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1
研究概览
简要总结
The purpose of this study is to determine whether treatment outcome for subjects dependent on prescription opioid analgesics can be improved by adding individual drug counseling to the prescription of buprenorphine/naloxone with standard medical management. This will be examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization treatment for those who do not respond successfully to the initial treatment; and c) a long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.
详细描述
This is a randomized 2-phase, open-label; multi-center study conducted in outpatient treatment settings. The main objective of this study is to identify an effective sublingual buprenorphine/naloxone treatment regimen for subjects dependent on prescription opioids. Phase 1 of this study will assess the prevailing one-month detoxification practice. This phase will assess the benefits of individual drug counseling in a short-term treatment paradigm. The second phase of this study will assess the benefit of individual drug counseling in a longer-term treatment paradigm for participants who did not respond successfully to the short-term buprenorphine/naloxone treatment. There is also a long-term follow-up assessment to determine outcomes at 1.5 years, 2.5 years, and 3.5 years after treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Physically dependent on opioids
- •Meet DSM-IV criteria for opioid dependence
排除标准
- •Known allergy or sensitivity to buprenorphine or naloxone
- •Unstable psychiatric disorder
- •Pregnant or lactating females
- •Liver function test results greater than 5 times the upper limit of normal range
研究组 & 干预措施
Buprenorphine/Nx with EMM
干预措施: Enhanced Medical Management (EMM) of Prescription Opiate Abuse (Behavioral)
Buprenorphine/Nx with SMM
干预措施: Standard Medical Management (SMM) of Prescription Opiate Abuse (Behavioral)
结局指标
主要结局
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1
时间窗: 12 weeks
In Phase 1, successful outcome was defined as completing week 12 with self-reported opioid use on no more than 4 days in a month, absence of 2 consecutive opioid-positive urine test results, no additional substance use disorder treatment (other than self-help), and no more than 1 missing urine sample during the 12 weeks.
The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment
时间窗: 12 weeks in Phase 2 period (i.e., 24 weeks into the study)
In phase 2, successful outcome was defined as abstaining from opioids during week 12 (the final week of buprenorphine-naloxone stabilization) and during at least 2 of the previous 3 weeks (weeks 9-11). This outcome measure required substantial improvement but not complete abstinence.
次要结局
- The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition Phase 2, 8-week Posttreatment Follow-up(24 weeks in Phase 2 period (i.e., 36 weeks into the study))
- The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 1 by Chronic Pain Condition(12 weeks)
- The Number of Participants Attaining Successful Opioid Use Outcomes in Phase 2 by Chronic Pain Condition(12 weeks)
- The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 1(12 weeks)
- The Number of Participants With and Without Any Lifetime Use of Heroin Attaining Successful Opioid Use Outcomes in Phase 2(12 weeks)
研究者
Roger D. Weiss
Chief Divsion of Alcohol and Drug Abuse; Professor of Psychiatry
Mclean Hospital