🔎 Trials Near Me

Home › Opioid Overdose › NCT06757140

Opioid Drug Interaction Study

RecruitingPhase 1/2

Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

Who can join

Ages 18 to 55 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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
* self-reported sedative-like drug use
* women of childbearing potential must not be pregnant or breastfeeding at screening and be using an effective form of contraception throughout study participation
* otherwise healthy as determined by the medical/research team based on medical history, physical examination, vital signs, laboratory chemistries (blood chemistry with liver function tests and hematology, urinalysis and microscopic evaluation, 12-lead electrocardiogram)
* willing and able to comply with all testing requirements defined in the protocol
* adequate venous access (determined by RN) for pharmacokinetic blood draws

Exclusion Criteria:

* 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)
* clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range)
* current or past history of major psychiatric disorder that would limit ability to participate in the study (e.g., bipolar disorder).
* recent use of CYP2C9, CYP2D6 and CYP3A4 inhibitor or inducer that is long-acting and not amenable to a wash-out period after enrollment
* known hypersensitivity to any of the study drugs
* currently pregnant or breastfeeding
* currently under parole or probation with urine testing requirements

About the study

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.

What is being tested

Sponsor: Shanna Babalonis, PhD · Participants: 25 · Started: Apr 1, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06757140

Locations in the U.S.

KentuckyUniversity of Kentucky, Lexington

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.