Title
Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1
CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence
Phase
Phase 3Lead Sponsor
National Institute on Drug Abuse (NIDA)Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Heroin Dependence Substance-Related DisordersIntervention/Treatment
buprenorphine naloxone ...Study Participants
0The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.
The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.
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