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 17, 2016
Last verified: August 2016

April 18, 2001
August 17, 2016
August 1999
August 2001   (final data collection date for primary outcome measure)
  • Craving
  • Retention
  • Opioid withdrawal
  • Subjective rating
  • Subjective rating
  • Craving
  • Retention
  • Opioid withdrawal
Complete list of historical versions of study NCT00015340 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14
Buprenorphine/Nx Treatment of Heroin Dependence-A Compassionate Use Study
The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use 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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Opioid Dependence
  • Substance-Related Disorders
Drug: Buprenorphine/naloxone
Experimental: Buprenorphine/Naloxone
Intervention: Drug: Buprenorphine/naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
582
September 2001
August 2001   (final data collection date for primary outcome measure)

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

Both
18 Years to 59 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00015340
NIDA-5-0013-14, Y01-5-0013-14
Not Provided
Not Provided
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
New York MDRU
Study Chair: Paul Casadonte, M.D. New York VAMC
National Institute on Drug Abuse (NIDA)
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP