Who is eligible for clinical trial NCT06757140?

Participants must meet the protocol's inclusion criteria for Drug Interactions. The stated age range is 18 Years to 55 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06757140 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-13

Opioid Drug Interaction Study (NCT06757140)

Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Shanna Babalonis, PhD

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (11 items).

Location: University of Kentucky — Lexington, Kentucky

Age range: 18 Years to 55 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Kentucky — Lexington, Kentucky

📞 Contact the Study Coordinator

Phone: (859) 323-0002

Email: paul.nuzzo@uky.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗