Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

This study has been completed.
Sponsor:
Collaborator:
New York MDRU
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00015340
First received: April 18, 2001
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Heroin Dependence
Substance-Related Disorders
Drug: Buprenorphine/naloxone
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Craving
  • Retention
  • Opioid withdrawal
  • Subjective rating

Estimated Enrollment: 0
Study Start Date: November 1997
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 CS 1008 A and B.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

completions of CS 1008 A/B

Exclusion Criteria:

Significant medical or psychiatric illness. Non-compliance with study procedures in CS 1008 A/B

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00015340

Locations
United States, New York
New York VAMC
New York, New York, United States, 10010
Sponsors and Collaborators
New York MDRU
Investigators
Principal Investigator: Paul Casadonte, M.D. New York VAMC
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00015340     History of Changes
Other Study ID Numbers: NIDA-5-0013-14, Y01-5-0013-14
Study First Received: April 18, 2001
Last Updated: August 26, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Substance-Related Disorders
Heroin Dependence
Chemically-Induced Disorders
Mental Disorders
Opioid-Related Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 29, 2014