Oral Abuse Potential Study of Nalbuphine

Trevi Therapeutics

Status and phase: Completed; Phase 1

Conditions: Nalbuphine; Opioid Abuse

Treatments: Drug: Placebo solution; Drug: Nalbuphine HCl solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04018664

Protocol 1008910 (TR08)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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56 participants in 8 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo 150 mL flavored beverage

Treatment:

Drug: Placebo solution

90 mg nalbuphine HCl solution

Experimental group

Description:

90 mg nalbuphine HCl solution 9 mL × 10 mg/mL hydromorphone HCl + 141 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution

120 mg nalbuphine HCl solution

Experimental group

Description:

120 mg nalbuphine HCl solution 12 mL × 10 mg/mL hydromorphone HCl + 138 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution

150 mg nalbuphine HCl solution

Experimental group

Description:

150 mg nalbuphine HCl solution 15 mL × 10 mg/mL hydromorphone HCl + 135 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution

180 mg nalbuphine HCl solution

Experimental group

Description:

180 mg nalbuphine HCl solution 18 mL × 10 mg/mL hydromorphone HCl + 132 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution

270 mg nalbuphine HCl solution

Experimental group

Description:

270 mg nalbuphine HCl solution 27 mL × 10 mg/mL hydromorphone HCl + 123 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution

Up to 405 mg nalbuphine HCl solution

Experimental group

Description:

Up to 405 mg nalbuphine HCl solution Up to 40.5 mL × 10 mg/mL hydromorphone HCl + at least 109.5 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution

Up to 540 mg nalbuphine HCl solution

Experimental group

Description:

Up to 540 mg nalbuphine HCl solution Up to 54 mL × 10 mg/mL hydromorphone HCl + at least 96 mL flavored beverage

Treatment:

Drug: Nalbuphine HCl solution