Trial Outcomes & Findings for Oral Abuse Potential Study of Nalbuphine (NCT NCT04018664)

Last Updated: 2025-05-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

56 participants

Primary outcome timeframe

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

Results posted on

2025-05-21

Participant Flow

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

Participant milestones

Participant milestones
Measure	Placebo Placebo 150 mL flavored beverage Placebo solution: Placebo	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	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	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	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	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	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	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
Overall Study STARTED	14	6	6	6	6	6	6	6
Overall Study COMPLETED	14	6	6	6	6	6	6	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Abuse Potential Study of Nalbuphine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=14 Participants Placebo 150 mL flavored beverage Placebo solution: Placebo	90 mg Nalbuphine HCl Solution n=6 Participants 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	120 mg Nalbuphine HCl Solution n=6 Participants 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	150 mg Nalbuphine HCl Solution n=6 Participants 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	180 mg Nalbuphine HCl Solution n=6 Participants 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	270 mg Nalbuphine HCl Solution n=6 Participants 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	Up to 405 mg Nalbuphine HCl Solution n=6 Participants 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	Up to 540 mg Nalbuphine HCl Solution n=6 Participants 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	Total n=56 Participants Total of all reporting groups
Age, Continuous	33.4 years STANDARD_DEVIATION 8.3 • n=5 Participants	38.5 years STANDARD_DEVIATION 11.2 • n=7 Participants	33.2 years STANDARD_DEVIATION 7.3 • n=5 Participants	31.0 years STANDARD_DEVIATION 9.4 • n=4 Participants	37.3 years STANDARD_DEVIATION 13.6 • n=21 Participants	34.8 years STANDARD_DEVIATION 5.6 • n=10 Participants	34.3 years STANDARD_DEVIATION 11.9 • n=115 Participants	42.5 years STANDARD_DEVIATION 12.3 • n=24 Participants	35.3 years STANDARD_DEVIATION 9.9 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	8 Participants n=42 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=24 Participants	48 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=10 Participants	5 Participants n=115 Participants	6 Participants n=24 Participants	53 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	4 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	8 Participants n=42 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=10 Participants	2 Participants n=115 Participants	6 Participants n=24 Participants	38 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=24 Participants	6 Participants n=42 Participants
Region of Enrollment Canada	14 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	6 participants n=10 Participants	6 participants n=115 Participants	6 participants n=24 Participants	56 participants n=42 Participants
BMI	26.48 kg/m**2 STANDARD_DEVIATION 3.45 • n=5 Participants	26.17 kg/m**2 STANDARD_DEVIATION 3.15 • n=7 Participants	25.53 kg/m**2 STANDARD_DEVIATION 4.04 • n=5 Participants	23.48 kg/m**2 STANDARD_DEVIATION 2.57 • n=4 Participants	26.18 kg/m**2 STANDARD_DEVIATION 4.39 • n=21 Participants	25.43 kg/m**2 STANDARD_DEVIATION 3.62 • n=10 Participants	24.53 kg/m**2 STANDARD_DEVIATION 3.17 • n=115 Participants	22.32 kg/m**2 STANDARD_DEVIATION 1.55 • n=24 Participants	25.23 kg/m**2 STANDARD_DEVIATION 3.44 • n=42 Participants

PRIMARY outcome

Timeframe: 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

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