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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Johns Hopkins University |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00142727 |
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.
Condition | Intervention | Phase |
Opioid-Related Disorders |
Drug: Methadone Drug: Full opioid agonist Drug: Partial opioid agonist Drug: Opioid antagonist |
Phase II |
ChemIDplus related topics: | Methadone Methadone hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence |
Estimated Enrollment: | 16 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |||||
Johns Hopkins University (BPRU) Bayview Campus | |||||
Baltimore, Maryland, United States, 21224 6823 |
National Institute on Drug Abuse (NIDA) |
Johns Hopkins University |
Principal Investigator: | Eric C. Strain, MD | Johns Hopkins University |
Study ID Numbers: | NIDA-08045-6, R01-08045-6, DPMC |
First Received: | September 1, 2005 |
Last Updated: | July 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00142727 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
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