Oral Abuse Potential Study of Nalbuphine

A Study to Evaluate the Oral Abuse Potential of Nalbuphine Solution and Extended-Release Intact Tablets in Non-Dependent, Recreational Opioid Users

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04018664

Enrollment

Registered

2019-07-12

Start date

2018-05-29

Completion date

2020-06-02

Last updated

2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nalbuphine, Opioid Abuse

Keywords

nalbuphine, abuse potential

Brief 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). 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.

Interventions

DRUGNalbuphine HCl solution

nalbuphine solution administered at various strengths

DRUGPlacebo solution

Placebo

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

For each dosing cohort, an unblinded statistician, not otherwise involved in the study, will prepare a list of subject randomization numbers. These randomization numbers will be used to prepare individual subject doses. Sealed qualification code break envelopes will be available for each subject in case of emergency. Upon completion of each cohort of subjects, the randomization codes for the completed subjects will be unblinded by the CRU pharmacy. After unblinding, the safety data will be reviewed to determine if dosing can proceed for the next planned dosing cohort,

Intervention 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

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male or female subjects 18 to 55 years of age * Current opioid users who have used opioids for recreational (non-therapeutic) purposes

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
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).	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

Countries

Canada

Participant flow

Recruitment details

Only Part A of this study was completed. Treatment arms summarized are those that were used on in Part A.

Participants by arm

Arm	Count
Placebo Placebo 150 mL flavored beverage Placebo solution: Placebo	14
90 mg Nalbuphine HCl Solution 90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
120 mg Nalbuphine HCl Solution 120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
150 mg Nalbuphine HCl Solution 150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
180 mg Nalbuphine HCl Solution 180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
270 mg Nalbuphine HCl Solution 270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
Up to 405 mg Nalbuphine HCl Solution Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
Up to 540 mg Nalbuphine HCl Solution Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage Nalbuphine HCl solution: nalbuphine solution administered at various strengths	6
Total	56

Baseline characteristics

Characteristic	Placebo	90 mg Nalbuphine HCl Solution	120 mg Nalbuphine HCl Solution	150 mg Nalbuphine HCl Solution	180 mg Nalbuphine HCl Solution	270 mg Nalbuphine HCl Solution	Up to 405 mg Nalbuphine HCl Solution	Up to 540 mg Nalbuphine HCl Solution	Total
Age, Continuous	33.4 years STANDARD_DEVIATION 8.3	38.5 years STANDARD_DEVIATION 11.2	33.2 years STANDARD_DEVIATION 7.3	31.0 years STANDARD_DEVIATION 9.4	37.3 years STANDARD_DEVIATION 13.6	34.8 years STANDARD_DEVIATION 5.6	34.3 years STANDARD_DEVIATION 11.9	42.5 years STANDARD_DEVIATION 12.3	35.3 years STANDARD_DEVIATION 9.9
BMI	26.48 kg/m**2 STANDARD_DEVIATION 3.45	26.17 kg/m**2 STANDARD_DEVIATION 3.15	25.53 kg/m**2 STANDARD_DEVIATION 4.04	23.48 kg/m**2 STANDARD_DEVIATION 2.57	26.18 kg/m**2 STANDARD_DEVIATION 4.39	25.43 kg/m**2 STANDARD_DEVIATION 3.62	24.53 kg/m**2 STANDARD_DEVIATION 3.17	22.32 kg/m**2 STANDARD_DEVIATION 1.55	25.23 kg/m**2 STANDARD_DEVIATION 3.44
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants	6 Participants	6 Participants	6 Participants	6 Participants	4 Participants	5 Participants	6 Participants	53 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Race (NIH/OMB) Black or African American	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	6 Participants
Race (NIH/OMB) White	8 Participants	5 Participants	4 Participants	4 Participants	5 Participants	4 Participants	2 Participants	6 Participants	38 Participants
Region of Enrollment Canada	14 participants	6 participants	6 participants	6 participants	6 participants	6 participants	6 participants	6 participants	56 participants
Sex: Female, Male Female	0 Participants	3 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	8 Participants
Sex: Female, Male Male	14 Participants	3 Participants	3 Participants	5 Participants	5 Participants	6 Participants	6 Participants	6 Participants	48 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 14	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6
other Total, other adverse events	0 / 14	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6
serious Total, serious adverse events	0 / 14	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6

Outcome results

Primary

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

Time frame: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, and 24 hours post-dose

Population: C max

Arm	Measure	Value (MEAN)	Dispersion
90 mg Nalbuphine HCl Solution	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).	21.70 microgram/L	Standard Deviation 6.65
120 mg Nalbuphine HCl Solution	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).	51.90 microgram/L	Standard Deviation 26.89
150 mg Nalbuphine HCl Solution	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).	68.67 microgram/L	Standard Deviation 30.19
180 mg Nalbuphine HCl Solution	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).	76.60 microgram/L	Standard Deviation 51.34
270 mg Nalbuphine HCl Solution	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).	56.00 microgram/L	Standard Deviation 6.09
Up to 405 mg Nalbuphine HCl Solution	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).	158.55 microgram/L	Standard Deviation 115.65
Up to 540 mg Nalbuphine HCl Solution	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).	196.83 microgram/L	Standard Deviation 92.34

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Oral Abuse Potential Study of Nalbuphine

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Masking description

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Countries

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

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).