Opioid Drug Interaction Study
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanna Babalonis, PhD
About this trial
This study will examine the effects of doses of opioid/placebo and doses of alprazolam/placebo, alone and in combination. The primary outcomes are pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) and pharmacokinetic outcomes (from blood samples) to determine the interaction effects of these compounds.
Eligibility criteria
Qualifiers
English-speaking and literate participants, able to understand and sign Informed Consent Document
ages 18 to 55 years old inclusive
BMI of greater than/equal to 17 and approximately less than or equal to 30
self-reported opioid use
Disqualifiers
physical dependence on alcohol, opioids, benzodiazepines or sedative/hypnotics requiring medical management/detoxification
seeking treatment for opioid or any other drug use
acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD])
clinically significant abnormal ECG (as determined by study physician/cardiologist)
Trial design
Treatments tested in this trial
- Alprazolam
- Oxycodone
- Placebo
Treatment groups
25 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Shanna Babalonis, PhD
Lead sponsor
University of Kentucky
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov