The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

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 determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

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

Criteria

Inclusion Criteria:

DSM-IV diagnosis of current opiate dependence

males and non-pregnant, non-nursing female

18-59 yrs of age

Exclusion Criteria:

Any significant medical condition

AST or ALT levels greater than 3x's the upper limit of normal level

Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

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-5-0013-1; Y01-5-0013-1
Record last reviewed:  January 1999
Last Updated:  February 16, 2005
Record first received:  April 18, 2001
ClinicalTrials.gov Identifier:  NCT00015171
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08