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New treatment option for Drug Interactions
Official title Opioid Drug Interaction Study
ClinicalTrials.gov ID: NCT06757140
What this study is testing
What is Alprazolam?
Alprazolam is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for drug interactions.
Also referred to as Xanax.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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
You likely can't join if
- 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...
- 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).
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.