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Pain relief combo falls short: early trial halted

NCT ID NCT04251819

Symptom relief Sponsor: University of Alabama at Birmingham 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 study tested whether adding baclofen (a muscle relaxant) to buprenorphine (a painkiller) could improve pain relief in 19 healthy volunteers. Participants received either a placebo or baclofen alongside buprenorphine and then underwent heat-based pain tests. The trial was terminated early, so the results are not conclusive.

What this could mean

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

Active substance
buprenorphine and baclofen
What this could lead to
If it worked, this combination could offer better pain relief with lower opioid doses, potentially reducing side effects and addiction risk.
What could go wrong
The trial was terminated early and only included 19 healthy volunteers, so results are very limited. It is not known if the combination is safe or effective for people with pain.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

19 people

The number who actually took part.

Started

Jan 2021

Finished

Jun 2024

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 18 years or older * general good health * English speaking Exclusion Criteria: * Pregnant or nursing * Opioid use disorder or any substance use disorder other than nicotine * Prescribed agonist treatment for opioid dependence or prescribed opioids for a medical condition * Prescribed naltrexone * Known sensitivity to buprenorphine, naloxone, or baclofen * Acute or chronic pain condition * Trouble breathing or a pulmonary condition * Prescribed benzodiazepines or daily use of benzodiazepines * Positive drug screen (positive cannabis result allowed) * Cognitive impairment or psychiatric disorder requiring treatment * Uncontrolled hypertension

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Conditions

The condition(s) this trial relates to.

Acute Pain agnosia pain agnosia

As listed by the trial registrant

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

Acute pain Analgesia

Contacts and locations

Locations

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35209, United States

More trials for these conditions

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