Opioid Agonist and Antagonist Effects on Opioid Dependence

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00142727
• Other study ID #: NIDA-08045-6
• Secondary ID: R01-08045-6DPMC
• Status: Terminated
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: January 11, 2017
• Start date: January 2004
• Est. completion date: February 2006

Study information

• Verified date: July 2007
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Methadone

• Full opioid agonist

• Partial opioid agonist

• Opioid antagonist

Locations

Country	Name	City	State
United States	Johns Hopkins University (BPRU) Bayview Campus	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opiate withdrawal		up to one day
Primary	Opiate agonist symptoms		up to one day
Primary	Physiologic measures		up to one day