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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Johns Hopkins University
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00142727     History of Changes
Other Study ID Numbers: NIDA-08045-6, R01-08045-6, DPMC
Study First Received: September 1, 2005
Last Updated: July 10, 2007
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotic Antagonists
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014