Back to resultsBuprenorphine and Naloxone Combination Study - 10
Primary Purpose
Heroin Dependence, Opioid-Related Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine/naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence
Eligibility Criteria
Inclusion Criteria: Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent. Exclusion Criteria: LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.
Sites / Locations
- New York MDRU
Outcomes
Primary Outcome Measures
Physiological measures
Measurements of buprenorphine and naloxone in plasma
Subjective symptoms measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00015288
First Posted
April 18, 2001
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
New York MDRU
1. Study Identification
Unique Protocol Identification Number
NCT00015288
Brief Title
Buprenorphine and Naloxone Combination Study - 10
Official Title
PK0496 Pharmacokinetics of Buprenorphine
Study Type
Interventional
2. Study Status
Record Verification Date
August 1998
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
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 to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.
Detailed Description
The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
0 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Primary Outcome Measure Information:
Title
Physiological measures
Title
Measurements of buprenorphine and naloxone in plasma
Title
Subjective symptoms measures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.
Exclusion Criteria:
LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.
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 Combination Study - 10
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