The purpose of this study is to determine the efficacy and safety of a buprenorphine/naloxone sublingual tablet formulation as an office-based therapy for opiate-dependence treatment.

Condition	Treatment or Intervention	Phase
Opioid-Related Disorders	Drug: Buprenorphine/naloxone	Phase II

Ages Eligible for Study:  21 Years   -   50 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

California
      Friends Research Institute, Los Angeles,  California,  90025,  United States

Study chairs or principal investigators

Walter Ling, M.D.,  Principal Investigator,  Friends Research Institute   

Study ID Numbers:  NIDA-3-0010-9; Y01-3-0010-9
Record last reviewed:  December 2002
Last Updated:  December 3, 2004
Record first received:  September 20, 1999
ClinicalTrials.gov Identifier:  NCT00000344
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08