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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

Primary Purpose

Heroin Dependence, Opioid-Related Disorders

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heroin Dependence
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 Heroin Dependence

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals must be 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
Subjective dose estimate
Observed withdrawal rating
Opioid agonist rating
Opioid antagonist rating
Pupil diameter
Compliance
Analog rating scale for drug effects
Drug effect characteristics
Dose order estimate-nurse
Dose order estimate-client

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
NCT00000326
Brief Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1
Official Title
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1(1)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Study Start Date
April 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 assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.
Detailed Description
Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

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
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
Subjective dose estimate
Title
Observed withdrawal rating
Title
Opioid agonist rating
Title
Opioid antagonist rating
Title
Pupil diameter
Title
Compliance
Title
Analog rating scale for drug effects
Title
Drug effect characteristics
Title
Dose order estimate-nurse
Title
Dose order estimate-client

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals must be 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

Citations:
Citation
(presented at ACNP 1997. Kamien, J.B., Mikulich, S.K., and Amass, L., Efficacy of the buprenorphine/naloxone tablet for daily vs. alternate-day opioid dependence treatment. Presented to the 1998 Meeting of the College on Problems of Drug Dependence.. Presented at ACNP 1997 and CPDD 1998.
Results Reference
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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

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