EUCTR2011-002229-23-GB进行中（未招募）不适用
A randomised, double blind, placebo controlled, cross over study of the effects of Buprenorphine Hemiadipate Hydrochloride/Naloxone Hydrochloride Dihydrate intravenous challenges in opioid dependent subjects stabilisied on sublingual Buprenorphine Hydrochloride/Naloxone Hydrochloride Dihydrate (Suboxone)
RB Pharmaceuticals Inc.0 个研究点开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subjects must be male or non-pregnant, non-lactating females.
- •2. Subjects must be at least 18 years of age.
- •3. Subjects must provide written informed consent and must be willing that their general practitioners be notified of their participation in the study.
- •4. Women of childbearing potential must use a medically acceptable means of birth
- •control and agree to continue its use during the study and for at least 3 months after the last dose of study drug. Women of childbearing potential are defined as all
- •women who have not had a complete surgical hysterectomy or who cannot be
- •documented as being at least 1 year postmenopausal. Medically acceptable forms of birth control include oral contraceptives, injectable or implantable methods, intrauterine devices, tubal ligation (if performed more than 1 year before screening), or double-barrier contraception.
- •5. Subjects must be able to communicate well with the investigator, understand and
- •comply with the requirements of the study, and understand the written informed
- •6. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision (DSM-IV-TR) criteria for opioid dependence at screening.
- •7. Self reported use of opioids for 15 of the past 28 days, with self reported use spanning the last 6 months.
- •8. Positive urine screen for opioids.
- •9. Subjects seeking treatment for opioid dependence or currently being treated with
- •buprenorphine but continuing to inject opioids 3 times per week.
- •10. Female subjects of childbearing potential must have a negative urine ß-hCG test prior to enrolment into the study.
- •11. Weight within 15% of ideal body weight according to current actuarial tables.
- •12. No active illness as determined by history, physical examination, electrocardiogram and clinical laboratory tests.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who are unwilling or unable to comply with the requirements of the protocol or who are in a situation or have a condition that, in the opinion of the investigator, may interfere with participation in the study.
- •2. Self reported use of methadone in the 30 days prior to the screening visit.
- •3. Subjects who, within 2 months prior to signing the informed consent document,
- •participated in any other clinical study in which medications were delivered or who
- •plan to participate in any other clinical study prior to the follow-up visit of the present trial.
- •4. Subjects with known allergy or sensitivity to buprenorphine or naloxone or to any of the excipients of Subutex®/Suboxone® or RBP-6300.
- •5. Subjects who are staff personnel or are affiliated with or a family member of staff
- •personnel directly involved in the study.
- •6. Subjects with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (for
- •example, those who are actively suicidal or have untreated schizophrenia).
- •7. Subjects with significant benzodiazepine use requiring medical detoxification or
- •alcohol dependence requiring medical detoxification. Current polysubstance abuse or dependence is not a reason for exclusion.
- •8. Subjects with a current diagnosis of chronic pain requiring opioid treatment.
- •9. Subjects with an ECG result that shows a repeated demonstration of a QTc interval
- •>450ms or a history of risk factors of Torsades de Pointes (eg heart failure,
- •hypokalemia, family history of Long QT Syndrome)
- •10. Subjects with aspartate aminotransferase (AST) levels =3 × upper limit of normal (ULN), alanine aminotransferase (ALT) levels =3 × ULN, or total bilirubin levels =1.5 × ULN.
- •11. Subjects with uncontrolled medical or psychiatric illness.
- •12. Subjects currently using opioid treatment (except buprenorphine), other opioid derivatives (e.g., methadone and analgesics), clonidine and related substances and clinically relevant CYP3A4 inhibitors or inducers.
- •13. Subjects positive for human immunodeficiency virus (HIV), or showing evidence of acute hepatitis B or C infection—acute infection is defined assubjects positive for hepatitis B surface antigen (HBsAg) and immunoglobulin M antibodies to hepatitis B core antigen (anti-HBc IgM), and those with clinical evidence of either acute hepatitis B infection or acute hepatitis C infection.Subjects with chronic active hepatitis should also be excluded Subjects with asymptomatic hepatitis B or C infection and those
- •asymptomatic currently being treated may be enrolled.
- •14. Subjects for whom treatment with Subutex®/Suboxone® is a contraindication as per the Summary of Product Characteristics (SmPC), such as subjects with severe respiratory insufficiency or severe hepatic insufficiency.
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