NIDA-CSP-999

Division
Title
A Multicenter Clinical Trial of Buprenorphine in Treatment of Opiate Dependence
Short Description
The primary purpose of this 16-week maintenance study is to determine the safety and effectiveness of 8 mg per day sublingual buprenorphine as compared to 1 mg per day sublingual buprenorphine in decreasing illicit opiate use as measured by urine testing 3 times a week, retention rates, and opiate craving and global rating scores in patients who meet DSM-III-R criteria for opiate dependence.
Release Date
Sep 02, 2015
Description

The primary purpose of this 16-week maintenance study is to determine the safety and effectiveness of 8 mg per day sublingual buprenorphine as compared to 1 mg per day sublingual buprenorphine in decreasing illicit opiate use as measured by urine testing 3 times a week, retention rates, and opiate craving and global rating scores in patients who meet DSM-III-R criteria for opiate dependence. A secondary purpose of the study is to gather more experience with two other doses of buprenorphine, 4 mg per day and 16 mg per day, regarding safety in the same population. Because the data will be used to support an NDA for buprenorphine in the treatment of opiate dependence, the data will be collected using FDA guidelines for good clinical practices.

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Study Data
Study Links
Study Documents
Case Report Form(s)
Deidentification Notes
Nulled Values