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)

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; Maintenance/substitution agent for the treatment of opioid dependence.; MedDRA version: 14.1Level: LLTClassification code 10012346Term: Dependence on opiatesSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2011-002229-23-GB
• Lead Sponsor: RB Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-01
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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
consent.
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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified