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Completed

NCT Number: NCT00015340

Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

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

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine/naloxone

Drug

Primary outcomes

  1. Craving

  2. Retention

  3. Opioid withdrawal

  4. Subjective rating

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

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Collaborators

  • New York MDRU

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2001
Study completion
2001
First posted
Apr 18, 2001
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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