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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3

Primary Purpose

Heroin Dependence, Opioid-Related Disorders

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Opioid-Related Disorders
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Sites / Locations

  • University of Colorado Health Sciences Center

Outcomes

Primary Outcome Measures

Drug use
Retention
Opioid agonist rating
Opioid antagonist rating
Compliance
Medication identification
Addiction Severity Index (ASI) Composite Score Rating

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
May 2, 2017
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000328
Brief Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3
Official Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Study Start Date
July 1997 (undefined)
Primary Completion Date
August 1997 (Actual)
Study Completion Date
August 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.
Detailed Description
S/A brief "Summary for the Public"

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Opioid-Related Disorders
Primary Outcome Measure Information:
Title
Drug use
Title
Retention
Title
Opioid agonist rating
Title
Opioid antagonist rating
Title
Compliance
Title
Medication identification
Title
Addiction Severity Index (ASI) Composite Score Rating

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency. Exclusion Criteria: Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Amass, Ph.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3

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