Back to resultsBuprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
Primary Purpose
Heroin Dependence, Opioid-Related Disorders
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heroin Dependence
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring drug dependence
Eligibility Criteria
Inclusion Criteria: Individual must be currently 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
Compliance
Dosing schedule preferences
Analog rating scale for dosing schedule effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00000327
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
NCT00000327
Brief Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
Official Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Study Start Date
June 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
5. Study Description
Brief Summary
The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
Detailed Description
Mon/Wed/Fri dosing with the 8 mg buprenorphine/naloxone tablet is as safe and effective as daily dosing and is preferred by patients to daily dosing. Multiple doses of the combination tablet (e.g. 16mg, 24mg) are well tolerated by patients. A 3 day schedule with take-outs is as effective as a 3-day schedule in which all medication is ingested at the clinic
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
Crossover Assignment
Masking
Double
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Heroin Dependence
Primary Outcome Measure Information:
Title
Drug use
Title
Retention
Title
Compliance
Title
Dosing schedule preferences
Title
Analog rating scale for dosing schedule effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individual must be currently 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
Citations:
Citation
Amass, L., Kamien, J.H., and Mikulich, S.K. Efficacy of and preference for 3-day vs daily dosing with the buprenorphine-naloxone combination tablet. presented to the 1998 Meeting of the College on Problems of Drug Dependence. Scottsdate, AZ (6/13-18). Presenting at CPDD 1998
Results Reference
background
Learn more about this trial
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2
We'll reach out to this number within 24 hrs