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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00015171

Enrollment

Registered

2001-04-18

Start date

1996-04-30

Completion date

1997-06-30

Last updated

2017-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Dependence, Substance-Related Disorders

Keywords

opioid dependence

Brief summary

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

Detailed description

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

Interventions

DRUGBuprenorphine/naloxone

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

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

Design outcomes

Primary

Measure	Time frame
Craving	—
Drug use	—
Retention	—
Opioid withdrawal	—
Subjective rating	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026