Opioid Agonist and Antagonist Effects on Opioid Dependence - Full Text View

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

Purpose

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

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

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

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	16
Study Start Date:	January 2004
Estimated Study Completion Date:	February 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00142727

Locations

United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Johns Hopkins University

Investigators

Principal Investigator:

Eric C. Strain, MD

Johns Hopkins University

More Information

Study ID Numbers:	NIDA-08045-6, R01-08045-6, DPMC
Study 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

Study placed in the following topic categories:

Methadone
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

ClinicalTrials.gov processed this record on January 16, 2009