A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users - ND
- Conditions
- Heroin UsersMedDRA version: 6.1Level: PTClassification code 10013663
- Registration Number
- EUCTR2006-005235-14-IT
- Lead Sponsor
- ESSEX ITALIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 310
Subjects must be male or non-pregnant, non-lactating females age 15 years or older and of any race. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for opioid dependence. All subjects must have a methadoneand buprenorphine-negative UDS result before randomization.
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
Subjects will not have had methadone or buprenorphine maintenance or detoxification within 30 days of enrollment. Women of childbearing potential must have a negative urine beta-human chorionic gonadotropin pregnancy test before enrollment, and all subjects must agree to use a medically acceptable form of contraception for the duration of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method