Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT05964335) enrolled 165 adults who were divided into four groups: one group received a placebo (a dummy treatment with no active ingredient), and three groups received different doses of an extended-release form of nalbuphine (NAL ER) — 27 mg, 54 mg, or 108 mg. The trial ran for six weeks and was primarily measuring changes in how often participants coughed over a 24-hour period, tracked using a digital cough monitor. The study appeared to be focused on coughing in people with a lung condition called idiopathic pulmonary fibrosis (IPF), a condition where the lungs gradually stiffen over time. The reported data shows that the main (primary) outcome — the percentage change in coughs per hour over 24 hours from the start to week six — was a reduction of about 0.19% in the placebo group, 0.90% in the 27 mg group, 1.27% in the 54 mg group, and 1.32% in the 108 mg group. For awake coughing specifically, the placebo group actually showed an increase of about 63%, while the three NAL ER groups showed reductions of around 45%, 51%, and 57% respectively. When looking at how many participants had at least a 75% drop in their 24-hour cough count, the reported data shows this was 5.4% of the placebo group, 17.5% in the 27 mg group, 37.1% in the 54 mg group, and 43.2% in the 108 mg group. A symptom questionnaire score related to coughing also showed reported reductions across all groups. The reported data also shows that the number of participants who experienced at least one adverse event (an unwanted medical occurrence during the trial) was 25 out of 40 in the placebo group, 30 out of 42 in the 27 mg group, 34 out of 43 in the 54 mg group, and 33 out of 40 in the 108 mg group — though the data does not detail the nature of those events here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41569557) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Interstitial Lung Disease Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with IPF (idiopathic pulmonary fibrosis) by a doctor following standard medical guidelines.
- You have rated your cough severity as 4 or higher (out of 10) on a cough scale during the screening and baseline period.
- You have had a chronic cough for at least 8 weeks before your screening appointment.
- Your blood oxygen level is 92% or above, measured by a pulse oximeter after sitting quietly for at least 5 minutes.
- Your lung capacity (how much air you can breathe out forcefully) is at least 40% of what is considered normal for someone like you, based on a breathing test.
- Your lungs' ability to transfer oxygen into the blood is at least 25% of what is considered normal, tested within the last 12 weeks or at screening.
Who may not be able to join:
- You currently use continuous oxygen therapy for more than 16 hours a day (occasional/intermittent oxygen use is allowed).
- You have difficulty swallowing, specifically if you cannot sip about 3 fluid ounces (89 mL) of water without coughing or choking.
- You have had a respiratory tract infection (such as a chest or throat infection) in the 8 weeks before your baseline visit.
- You have a history of aspiration pneumonitis (a lung condition caused by inhaling food, liquid, or stomach contents).
- You have been diagnosed with sleep apnea.
- Your kidney or liver function tests from screening came back abnormal.
- You have a known allergy or sensitivity to the study drug (nalbuphine) or any of its ingredients.
- You have a history of a major psychiatric disorder.
- You have a history of substance abuse.
- You have a significant medical condition or other circumstances that may make it difficult for you to complete the study (confirm with trial site).
- You are currently pregnant or breastfeeding.
- You have previously had bad reactions to opioid medications, such as stomach problems, dizziness, or allergic reactions.
- You have used opioid medications within 14 days before your baseline visit.
- You have used benzodiazepine medications (such as certain anxiety or sleep medicines) within 14 days before your baseline visit, or you would need to use them during the study.
- You have taken certain antidepressant medications called MAOIs, or the antibiotic linezolid, or methylene blue within 14 days before your baseline visit, or would need them during the study.
- You have used oral steroid treatments for cough within 4 weeks before your baseline visit, or would need them during the study.
- You have taken part in another clinical trial involving any experimental medication within 4 weeks before your baseline visit.
- You use cough suppressant medications, unless you have been on a stable dose for at least 14 days before your baseline visit and will stay on that same dose throughout the study.
- You take certain medications that affect serotonin levels in the body (which can interact with opioids), unless you have been on a stable dose for at least 14 days before your baseline visit and will stay on that same dose throughout the study.
- You take anti-fibrotic medications (treatments to slow lung scarring), unless you have been on a stable dose for at least 8 weeks before your baseline visit and will stay on that same dose throughout the study.
- You take certain medications that strongly affect how the body processes drugs (known as strong P450 inhibitors or inducers), unless you have been on a stable dose for at least 14 days before your baseline visit and will stay on that same dose throughout the study.
- You take a medication that is known to carry a risk of causing a specific serious heart rhythm problem called Torsade de Pointes, within 4 weeks before your baseline visit.
- You have recently changed the dose of any medication that may affect heart rhythm, within 4 weeks of screening.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Chief Development Officer, Trevi Therapeutics
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Relative Change From Baseline in 24-hour Cough Frequency at Week 6
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.