Opioid Agonist and Antagonist Effects on Opioid Dependence
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.
Drug: Full opioid agonist
Drug: Partial opioid agonist
Drug: Opioid antagonist
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence|
- Opiate withdrawal [ Time Frame: up to one day ]
- Opiate agonist symptoms [ Time Frame: up to one day ]
- Physiologic measures [ Time Frame: up to one day ]
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||February 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142727
|United States, Maryland|
|Johns Hopkins University (BPRU) Bayview Campus|
|Baltimore, Maryland, United States, 21224 6823|
|Principal Investigator:||Eric C. Strain, MD||Johns Hopkins University|