Back to resultsBuprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6
Primary Purpose
Heroin Dependence, Opioid-Related Disorders
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Test Drug
Placebo Drug
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring Heroin Dependence
Eligibility Criteria
Inclusion Criteria: Individuals must be healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures) 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Test Drug
Placebo Pill
Arm Description
Test drug to prevent heroine withdrawal
Placebo drug
Outcomes
Primary Outcome Measures
Observed withdrawal rating
Pupil diameter
Drug effect characteristics
Secondary Outcome Measures
Full Information
NCT ID
NCT00000331
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
NCT00000331
Brief Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3 - 6
Official Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-3
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (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 healthy, non-drug dependent volunteers.
Detailed Description
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
Heroin Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Drug
Arm Type
Experimental
Arm Description
Test drug to prevent heroine withdrawal
Arm Title
Placebo Pill
Arm Type
Placebo Comparator
Arm Description
Placebo drug
Intervention Type
Drug
Intervention Name(s)
Test Drug
Other Intervention Name(s)
test drug o
Intervention Type
Drug
Intervention Name(s)
Placebo Drug
Primary Outcome Measure Information:
Title
Observed withdrawal rating
Title
Pupil diameter
Title
Drug effect characteristics
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 healthy, non-drug dependent volunteers, be at least 18 years of age, and have no prior history of drug or alcohol abuse or dependence. Subjects must have had some minimal experience with opioids (e.g. at least two prior exposures)
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 II-3 - 6
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