Opioid Agonist and Antagonist Effects on Opioid Dependence

This study has been terminated.

(Study terminated due to halt in funding; may resume recruiting in future)

Sponsor:

Collaborator:

Johns Hopkins University

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00142727

First received: September 1, 2005

Last updated: July 10, 2007

Last verified: July 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

July 10, 2007

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Opiate withdrawal
Opiate agonist symptoms
Physiologic measures

Change History

Complete list of historical versions of study NCT00142727 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Opioid Agonist and Antagonist Effects on Opioid Dependence

Official Title ^ICMJE

The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Methadone
Drug: Full opioid agonist
Drug: Partial opioid agonist
Drug: Opioid antagonist

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00142727

Other Study ID Numbers ^ICMJE

NIDA-08045-6, R01-08045-6, DPMC

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Johns Hopkins University

Investigators ^ICMJE

Principal Investigator:

Eric C. Strain, MD

Johns Hopkins University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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