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Small study probes dangerous duo: opioids and sedatives

NCT ID NCT04315181

Knowledge-focused Sponsor: Sharon Walsh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 1 study looked at how opioids and sedatives affect the body and mind when taken together. Eleven healthy adults who use these drugs non-medically rated their drug liking and other effects. The goal was to understand the interaction between these common prescription medications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Opioid agonist and sedative
What this could lead to
If successful, this could help understand the risks of combining opioids and sedatives, potentially guiding safer prescribing practices.
What could go wrong
This is a very small, early-phase study (11 participants) focused on measuring effects, not testing a treatment. Results may not apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

11 people

The number who actually took part.

Started

Mar 2019

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy adults, ages 18-55 * Current non-medical use of opioids and sedatives Exclusion Criteria: * Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics * Seeking treatment for drug use * Significant medical problems

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Conditions

The condition(s) this trial relates to.

opioid abuse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use Sedative use

Contacts and locations

Locations

  • Center on Drug and Alcohol Research

    Lexington, Kentucky, 40508, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.