The purpose of this study is the safety and efficacy of Burprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Condition	Treatment or Intervention	Phase
Heroin Dependence Substance-Related Disorders	Drug: Buprenorphine/naloxone	Phase III

Further Study Details: 

The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed CS 1008 A and B.

Ages Eligible for Study:  18 Years   -   59 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

completions of CS 1008 A/B

Exclusion Criteria:

Significant medical or psychiatric illness. Non-compliance with study procedures in CS 1008 A/B

New York
      New York MDRU, New York,  New York,  10010,  United States

Study chairs or principal investigators

John Rotrosen, M.D.,  Principal Investigator,  New York MDRU   

Study ID Numbers:  NIDA-5-0013-14; Y01-5-0013-14
Record last reviewed:  November 1997
Last Updated:  December 3, 2004
Record first received:  April 18, 2001
ClinicalTrials.gov Identifier:  NCT00015340
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08