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Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

Primary Purpose

Heroin Dependence, Substance-Related Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring opioid dependence

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age Exclusion Criteria: Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Sites / Locations

  • New York MDRU

Outcomes

Primary Outcome Measures

Craving
Drug use
Retention
Opioid withdrawal
Subjective rating

Secondary Outcome Measures

Full Information

First Posted
April 18, 2001
Last Updated
January 13, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU
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1. Study Identification

Unique Protocol Identification Number
NCT00015171
Brief Title
Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1
Official Title
CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
January 1999
Overall Recruitment Status
Completed
Study Start Date
April 1996 (undefined)
Primary Completion Date
May 1997 (Actual)
Study Completion Date
June 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.
Detailed Description
The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Substance-Related Disorders
Keywords
opioid dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Craving
Title
Drug use
Title
Retention
Title
Opioid withdrawal
Title
Subjective rating

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age Exclusion Criteria: Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Rotrosen, M.D.
Organizational Affiliation
New York MDRU
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York MDRU
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

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