A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 241
- 主要终点
- Response Rate
研究概览
简要总结
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be males or non-pregnant, non-lactating females.
- •Subjects must be at least 15 years of age, of either sex, and any race.
- •Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules.
- •Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(18) for opioid dependence.
- •Subjects must have been receiving maintenance treatment with Subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening.
- •Subjects must not, according to self-report, have injected opioids more than four times in the month prior to screening.
- •Subjects must have an opioid-negative urine drug screening (UDS) result prior to randomization.
- •Each subject must confirm that he or she is practicing adequate contraception.
- •Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (β-hCG) test prior to enrollment in the study.
排除标准
- •Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
- •Subjects who are participating in any other clinical study in which medication(s) are being delivered.
- •Subjects with known allergy or sensitivity to naloxone.
- •Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study.
- •Subjects must not have serious untreated Axis I DSM-IV-TR psychiatric comorbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification.
- •Human immunodeficiency virus (HIV)-positive subjects with clinical acquired immunodeficiency syndrome (AIDS).
- •Subjects treated with generic buprenorphine.
研究组 & 干预措施
Suboxone
Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.
干预措施: Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484 (Drug)
Subutex
Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) during Weeks 2-4 with weekly access to take-home doses as of Week 2.
干预措施: Subutex, Buprenorphine Hydrochloride, SCH 28444 (Drug)
结局指标
主要结局
Response Rate
时间窗: Assessed by Day 7 of double-blind, double-dummy treatment period.
Response rate was defined as the percentage of participants who did not receive a dose increase from the dose given at the first dosing date by Day 7 of a one-week, randomized, double-blind, double-dummy treatment transfer phase.
次要结局
未报告次要终点