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NIDA-CTN-0002

Up one level Buprenorphine/Naloxone versus Clonidine for Outpatient Opiate Detoxification

For decades clinicians have been frustrated by the inability to successfully detoxify opiate addicted patients because opiate-based detoxification, one of the most effective means to achieving that goal, has been unavailable outside the very restrictive confines of narcotic treatment programs (NTPs). A new medication, Buprenorphine, shows promise as an effective aid for opiate detoxification. However, little data have been generated for the shorter-term use of Buprenorphine/Naloxone for this indication. Since the diversity of clinics in the CTN provides an unparalleled opportunity to conduct such a clinical endeavor, the utility of Buprenorphine/Naloxone in short term (13 day) detoxification in outpatient settings will be tested in the CTN.

**The data files and related study documentation were updated on December 13, 2006 to make the following changes.  Please update your files if you have already downloaded any study data/documentation:

1. A prefix was added to the deidentified patient identifier (DEIDNUM) to make analyses across trials easier.  The prefix is the trial number.

2. Formulas and derivation logic rules to the comments field in define.xml were included where possible.  Most variables are simple translations/mappings from the data source and do not require a comment.

3. Some of the graphical elements in the PDF CRF annotation were not appearing when Acrobat versions other than Acrobat 5 were used.   We have updated the PDF CRF files to alleviate this problem entirely.

4. Annotation for EXROUTE was added that to the CRF annotation.

5. Urinalysis lab results (external lab data) were added to the LB data files. The urinalysis lab data were joined with the CRF data by collection dates. If the lab file collection dates did not have a match to the CRF dates, they were omitted.

**The data files and related study documentation were updated on May 4, 2007 in order to increase compliance with SDTM current standards.  Please update your files if you have already downloaded any study data/documentation.  Any analyses currently underway should not be affected with these updates.


Materials & Links
Link Primary Manuscript
Folderish Form Mailer Data Files
File Study Protocol
Link Study Information
File Annotated CRF
File Study-Specific De-identification Notes

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