Opioid dependence MedDRA version: 9.1 Level: LLT Classification code 10013663 Term: Drug dependence
Conditions
Interventions
Trade Name: Suboxone
Product Name: Suboxone
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: Buprenorphine Hydrochloride
Conc
Sponsors
Schering-Plough Research Institute - A division of Schering-Plough Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be males or non-pregnant, non-lactating females. 2. Subjects must be at least 15 years of age, of either sex, and any race. 3. 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. 4. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(24) for opioid dependence. 5. Subjects must have a methadone- and buprenorphine-negative UDS result prior to randomization. 6. Each subject must confirm that he or she is practicing adequate contraception. Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or must be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who have been postmenopausal for =1 year (ie, women who have experienced 12 or more consecutive months of amenorrhea) will be exempted from the requirement to use contraception during the study. Acceptable methods include hormonal implants, injectables, combined oral contraceptives, hormonal intrauterine devices and surgical sterilization (eg, hysterectomy or tubal ligation). 7. Female subjects of childbearing potential must have a negative urine beta– human chorionic gonadotropin (beta-hCG) test prior to enrollment in the study. Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling. 2. 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. 3. Subjects who are participating in any other clinical study in which medication(s) are being delivered. 4. Subjects with known allergy or sensitivity to buprenorphine or naloxone. 5. Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. 6. Subjects with serious untreated Axis I DSM-IV-TR psychiatric co-morbidity (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. 7. HIV-positive subjects with clinical acquired immunodeficiency syndrome (AIDS). 8. Methadone or buprenorphine maintenance or detoxification within 30 days of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that direct Suboxone induction is not inferior to a Subutex-to-Suboxone induction as measured by response rate at Day 3. The response rate will be assessed by determining the proportion of subjects in each group who receive the scheduled dose of Suboxone at the Day 3 study visit.;Secondary Objective: The secondary objectives of this study will assess the overall clinical response to Suboxone as a function of the induction strategy by comparing the response of subjects inducted directly with Suboxone to those inducted with a Subutex-to-Suboxone procedure on 1) illicit opioid and non-opioid drug use as measured by urine drug screening (UDS), 2) illicit opioid and non-opioid drug use as measured by self-report on the Substance Use Inventory (SUI), 3) self-reported opioid withdrawal symptoms as measured by the Subjective Opiate Withdrawal Scale (SOWS), 4) observer-rated opioid withdrawal symptoms as measured by the Objective Opiate Withdrawal Scale (OOWS), 5) addiction-related problem profiles as measured by the Addiction Severity Index (ASI)–Lite, 6) compliance rate, and 7) response rate. ;Primary end point(s): The primary efficacy endpoint is the response rate to treatment assignment, which will be assessed by determining the proportion of subjects in each group who receive the scheduled dose of Suboxone at the Day 3 study visit. | — |
Countries
Czech Republic, France, Germany, Ireland, Italy, Lithuania, Portugal, Slovakia, Slovenia, Spain, United Kingdom
Outcome results
None listed