RECRUITING

Opioid Drug Interaction Study

Conditions

Drug Interactions Drug Kinetics inpatient study opioids opiates sedatives opioid misuse

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

Quick Facts

Study Start:2025-03

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06757140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Paul A Nuzzo

CONTACT

(859) 323-0002

paul.nuzzo@uky.edu

Principal Investigator

Shanna Babalonis, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40508

United States

Collaborators and Investigators

Sponsor: Shanna Babalonis, PhD

Shanna Babalonis, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2025-03

Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

inpatient study
opioids
opiates
sedatives
opioid misuse

Additional Relevant MeSH Terms

Drug Interactions
Drug Kinetics