Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

National Institutes of Health (NIH)

Status and phase: Completed; Phase 4

Conditions: Substance-Related Disorders; Opioid Dependence

Treatments: Drug: Buprenorphine/naloxone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00015340

NIDA-5-0013-14

Y01-5-0013-14

Details and patient eligibility

About

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

Full 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.

Enrollment: 582 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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582 participants in 1 patient group

Buprenorphine/Naloxone

Experimental group

Treatment:

Drug: Buprenorphine/naloxone