Opioid Agonist and Antagonist Effects on Opioid Dependence
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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 |
- 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 |
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 |
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| United States, Maryland | |
| Johns Hopkins University (BPRU) Bayview Campus | |
| Baltimore, Maryland, United States, 21224 6823 | |
| 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 Mental Disorders Methadone Analgesics, Opioid Narcotic Antagonists Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics |
ClinicalTrials.gov processed this record on May 22, 2013