Opioid-Related Disorders
Conditions
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.
Interventions
Sponsors
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opiate withdrawal | up to one day |
| Opiate agonist symptoms | up to one day |
| Physiologic measures | up to one day |
Countries
United States
Outcome results
None listed