Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00015340

Enrollment

582

Registered

2001-04-18

Start date

1999-08-31

Completion date

2001-09-30

Last updated

2017-01-12

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

Conditions

Opioid Dependence, Substance-Related Disorders

Keywords

Opioid Dependence

Brief summary

The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

Detailed description

The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Interventions

DRUGBuprenorphine/naloxone

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

Yes

Inclusion criteria

\- Completion of Cooperative Study 1008 A/B

Exclusion criteria

\- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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