Opioid Agonist and Antagonist Effects on Opioid Dependence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Opioid-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Methadone

Intervention Type DRUG

Full opioid agonist

Intervention Type DRUG

Partial opioid agonist

Intervention Type DRUG

Opioid antagonist

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No