Opioid Agonist and Antagonist Effects on Opioid Dependence
Primary Purpose
Opioid-Related Disorders
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Methadone
Full opioid agonist
Partial opioid agonist
Opioid antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders
Eligibility Criteria
Inclusion Criteria: Active opioid dependence Qualifies for opioid agonist treatment (e.g., methadone or buprenorphine) Fulfills DSM-IV diagnostic criteria for opioid dependence Exclusion Criteria: Significant medical problems, including insulin dependent diabetes mellitus Non-substance use psychiatric disorders (e.g., schizophrenia) Currently seeking treatment for substance abuse
Sites / Locations
- Johns Hopkins University (BPRU) Bayview Campus
Outcomes
Primary Outcome Measures
Opiate withdrawal
Opiate agonist symptoms
Physiologic measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00142727
First Posted
September 1, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT00142727
Brief Title
Opioid Agonist and Antagonist Effects on Opioid Dependence
Official Title
The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to halt in funding; may resume recruiting in future
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the acute agonist and antagonist effects of a full opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist medication in individuals who have different levels of physical opioid dependence.
Detailed Description
The pharmacological effects of opioids in opioid dependent individuals can vary as a function of the characteristics of the opioid being studied (e.g., whether it is an agonist, partial agonist, or antagonist; the dose administered; and the route of administration). Another important set of factors influencing the effects produced by opioids is the characteristics of the organism to which the opioid is being administered. One such characteristic is the level of physical dependence in individuals.
Participants in this study will be maintained on different dose levels of an opioid agonist (methadone). The participant will be challenged with a prototypic opioid agonist, antagonist, and a mixed agonist-antagonist with partial agonist features in order to determine the effects that each has on the human body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Type
Drug
Intervention Name(s)
Full opioid agonist
Intervention Type
Drug
Intervention Name(s)
Partial opioid agonist
Intervention Type
Drug
Intervention Name(s)
Opioid antagonist
Primary Outcome Measure Information:
Title
Opiate withdrawal
Time Frame
up to one day
Title
Opiate agonist symptoms
Time Frame
up to one day
Title
Physiologic measures
Time Frame
up to one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active opioid dependence
Qualifies for opioid agonist treatment (e.g., methadone or buprenorphine)
Fulfills DSM-IV diagnostic criteria for opioid dependence
Exclusion Criteria:
Significant medical problems, including insulin dependent diabetes mellitus
Non-substance use psychiatric disorders (e.g., schizophrenia)
Currently seeking treatment for substance abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C. Strain, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University (BPRU) Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224 6823
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Opioid Agonist and Antagonist Effects on Opioid Dependence
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