Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3

Conditions: Heroin Dependence; Substance-Related Disorders

Treatments: Drug: Buprenorphine/naloxone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00015171

Y01-5-0013-1

NIDA-5-0013-1

Details and patient eligibility

About

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

Full description

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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