Back to resultsBuprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4
Primary Purpose
Heroin Dependence, Opioid-Related Disorders
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Opioid-Related Disorders
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring drug dependence
Eligibility Criteria
Inclusion Criteria: Individuals must be at least 18 yrs 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 and have a history of IV opioid use. Exclusion Criteria: Individuals with evidence of anti 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
Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Analog rating scale for drug effects
Drug effect characteristics
Drug/Money Preferences
Secondary Outcome Measures
Full Information
NCT ID
NCT00000329
First Posted
September 20, 1999
Last Updated
May 2, 2017
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000329
Brief Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4
Official Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Study Start Date
April 1999 (undefined)
Primary Completion Date
August 1999 (Actual)
Study Completion Date
August 1999 (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
5. Study Description
Brief Summary
The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers
Detailed Description
Ongoing study - results not available at this time
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
Masking
Double
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Opioid-Related Disorders
Primary Outcome Measure Information:
Title
Subjective dose estimate
Title
Observed withdrawal rating
Title
Opioid agonist rating
Title
Opioid antagonist rating
Title
Pupil diameter
Title
Analog rating scale for drug effects
Title
Drug effect characteristics
Title
Drug/Money Preferences
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 yrs 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 and have a history of IV opioid use.
Exclusion Criteria:
Individuals with evidence of anti 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 II-1 - 4
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