NalbuphinePhase 1NCT04018664
Oral Abuse Potential Study of Nalbuphine
A Phase 1 study testing Nalbuphine HCl solution in people with Nalbuphine and Opioid Abuse, run by Trevi Therapeutics at 1 site in Canada.
Trial summary
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nalbuphine, Opioid Abuse
- What is being tested?
- Nalbuphine HCl solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2018to 2 Jun 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects 18 to 55 years of age
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes
Who cannot join
- Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
- Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
- History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
- History or presence of any clinically significant illness
- History of major mental illness that may affect the ability of the subject to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated.
This study has 2 parts: Part A and Part B.
Read the detailed description
This study will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution and placebo, in non-dependent, recreational opioid users. The study will be conducted in a single clinical research unit (CRU).
The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose) of nalbuphine solution to use in Part B. Part A of the study has two visits to the research clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3 days total) in the research clinic.
In the Main Study Treatment Phase in Part B, the total estimated duration between each dose of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights in the research clinic and approximately up to 4 days at home.
The primary objective of the Main Study is to evaluate the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution (the active comparator) and placebo in non-dependent, recreational opioid users.
- Conditions
- Nalbuphine, Opioid Abuse
- Being tested
- Nalbuphine HCl solution, Placebo solution
- Keywords
- nalbuphine, abuse potential
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine HCl solutionDrug
Also called NAL ER
nalbuphine solution administered at various strengths
Placebo solutionDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo
150 mL flavored beverage Receives: Drug: Placebo solution |
| 90 mg nalbuphine HCl solution | Experimental | 90 mg nalbuphine HCl solution
9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
| 120 mg nalbuphine HCl solution | Experimental | 120 mg nalbuphine HCl solution
12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
| 150 mg nalbuphine HCl solution | Experimental | 150 mg nalbuphine HCl solution
15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
| 180 mg nalbuphine HCl solution | Experimental | 180 mg nalbuphine HCl solution
18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
| 270 mg nalbuphine HCl solution | Experimental | 270 mg nalbuphine HCl solution
27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
| Up to 405 mg nalbuphine HCl solution | Experimental | Up to 405 mg nalbuphine HCl solution
Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
| Up to 540 mg nalbuphine HCl solution | Experimental | Up to 540 mg nalbuphine HCl solution
Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage Receives: Drug: Nalbuphine HCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B).
Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max
Measured: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start29 May 2018
- Primary completion3 Dec 2018
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NalbuphineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study. Part A: Dose selection phase Part B: Treatment Periods 1-7
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Chief Development Officer, Study director, Trevi Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018664
- Sponsor's protocol ID
- Protocol 1008910 (TR08)
- Status last verified
- May 2025
- First submitted
- 30 May 2019
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users
- ClinicalTrials.gov ID
- NCT04018664
- Acronym / sponsor ID
- Protocol 1008910 (TR08)
- Conditions
- Nalbuphine, Opioid Abuse
- Keywords
- nalbuphine, abuse potential
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 29 May 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated.
This study has 2 parts: Part A and Part B.
Detailed description
This study will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 2-part, 7-way crossover study to determine the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution and placebo, in non-dependent, recreational opioid users. The study will be conducted in a single clinical research unit (CRU).
The purpose of Part A is to find the appropriate doses (a low, intermediate, and high dose) of nalbuphine solution to use in Part B. Part A of the study has two visits to the research clinic: a screening visit and dose selection visit. The visits will involve a 2-night stay (3 days total) in the research clinic.
In the Main Study Treatment Phase in Part B, the total estimated duration between each dose of study drug is approximately up to 7 days, of which the subject will spend 3 days/2 nights in the research clinic and approximately up to 4 days at home.
The primary objective of the Main Study is to evaluate the abuse potential of orally administered nalbuphine solution and nalbuphine ER intact tablets relative to hydromorphone solution (the active comparator) and placebo in non-dependent, recreational opioid users.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study. Part A: Dose selection phase Part B: Treatment Periods 1-7
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo solutionPlacebo 150 mL flavored beverage |
| 90 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solution90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage |
| 120 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solution120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage |
| 150 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solution150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage |
| 180 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solution180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage |
| 270 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solution270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage |
| Up to 405 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solutionUp to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage |
| Up to 540 mg nalbuphine HCl solution | Experimental | Drug: Nalbuphine HCl solutionUp to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female subjects 18 to 55 years of age
- Current opioid users who have used opioids for recreational (non-therapeutic) purposes
Key exclusion criteria (5 listed)
- Self-reported substance or alcohol dependence (excluding nicotine and caffeine)
- Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking for at least 8 hours during the in clinic periods.
- History or presence of clinically significant abnormality as assessed by physical examination, medical history, ECGs, vital signs, or laboratory values.
- History or presence of any clinically significant illness
- History of major mental illness that may affect the ability of the subject to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalbuphine HCl solutionAlso: NAL ERnalbuphine solution administered at various strengths | Drug | 120 mg nalbuphine HCl solution, 150 mg nalbuphine HCl solution, 180 mg nalbuphine HCl solution, 270 mg nalbuphine HCl solution, 90 mg nalbuphine HCl solution, Up to 405 mg nalbuphine HCl solution, Up to 540 mg nalbuphine HCl solution |
| Placebo solutionPlacebo | Drug | Placebo |
Primary outcome
To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B).
Time frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose
Only Part A of thie study was conducted because of closure the clinical research unit (CRU) before Part B could be initiated. Summary statistics are provided for C-max
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Nalbuphine
RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
RecruitingPhase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
Idiopathic Pulmonary Fibrosis
RecruitingPhase 3
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
Idiopathic Pulmonary Fibrosis
Not yet recruitingPhase 4
Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Recruiting
Analgesic Efficacy of Fascia Iliaca Compartment Block Compared With Intrathecal Nalbuphine for Hip Surgery Under Spinal Anesthesia
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Development Officer study director
Trevi Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nalbuphine HCl solution in people with Nalbuphine and Opioid Abuse, run by Trevi Therapeutics at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Identify the Appropriate Low, Intermediarte, and High Doses of Nalbuphine Solution (Part A) to be Administered as Single Doses in the Treatment Phase of the Main Study (Part B). (time frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.