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New cough pill shows promise in clinical trial

NCT ID NCT05962151

Symptom relief Sponsor: Trevi Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a tablet called nalbuphine ER in 66 adults with refractory chronic cough (a cough lasting over a year with no clear cause). The goal was to see if the drug could reduce how often people coughed over 24 hours. Participants took either the drug or a placebo, then switched after a period. The main measure was change in cough frequency using a digital monitor.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Nov 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

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.

Key Inclusion Criteria: * Diagnosis of refractory chronic cough (RCC) for at least one year * Chest radiograph or CT of thorax within 24 months or during screening not demonstrating any significant abnormalities contributing to RCC Exclusion Criteria: * Diagnosis of sleep apnea * Respiratory tract infection within 6 weeks of Baseline * History of bronchiectasis, COPD, or IPF * History of uncontrolled asthma * Current smokers/vapers, quit smoking with \<=12 months, using nicotine supplements, or history of \>=20 pack years * History of major psychiatric disorder * History of substance abuse * Pregnant or lactating females * Known intolerance to opioids * Abnormal kidney or liver functions based on Screening lab results. * Known hypersensitivity to nalbuphine or to NAL ER excipients * Previous participation in a nalbuphine ER clinical study * Use of opiates, benzodiazepines, or MAOIs within 14 days of Baseline * Use of pregabalin, gabapentin, thalidomide for treatment of cough within 14 days of Baseline * Use of ACE inhibitors within 12 weeks of Baseline * Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline * Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening. * Use of unstable doses of cough suppressants within 14 days of Baseline * Use of unstable doses of medications that affect serotonergic neurotransmission that may cause serotonin syndrome with opioids within14 days of Baseline * Use of unstable doses of P450 isozyme inhibitors/inducers within 14 days of Baseline Other protocol defined inclusion/exclusion criteria applied.

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Conditions

The condition(s) this trial relates to.

Chronic Cough Cough

As listed by the trial registrant

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

Refractory chronic cough

Contacts and locations

Locations

  • Accellacare North London

    Northwood, Middlesex, HA6 2RN, United Kingdom

  • Accellacare South London

    Orpington, Kent, BR5 3QG, United Kingdom

  • Accellacare Warwickshire

    Coventry, Warwickshire, CV3 4FJ, United Kingdom

  • Accellacare Yorkshire

    Shipley, Yorkshire, BD18 3SA, United Kingdom

  • Belfast City Hospital

    Belfast, Northern Ireland, BT9 7AB, United Kingdom

  • CIC Mauricie Inc.

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Egin Research Ltd

    High Wycombe, HP11 2QW, United Kingdom

  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital

    Cottingham, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

  • Inspiration Research

    Toronto, Ontario, M5T 3A9, Canada

  • Kings College Hospital NHS Foundation Trust

    London, Greater London, SE5 9RS, United Kingdom

  • McMaster University Medical Centre

    Hamilton, Ontario, L8N 3Z5, Canada

  • North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust

    North Shields, Tynemouth, NE29 8NH, United Kingdom

  • University Hospital of South Manchester NHS Foundation Trust (UHSM) - Wythenshawe Hospital

    Manchester, Greater Manchester, M23 9LT, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2GW, United Kingdom

More trials for these conditions

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