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Oral Abuse Potential Study of Nalbuphine

NCT04018664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-05-21

Study results available
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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.

Conditions

  • Nalbuphine
  • Opioid Abuse

Interventions

DRUG

Nalbuphine HCl solution

nalbuphine solution administered at various strengths

DRUG

Placebo solution

Placebo

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Trevi Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Development Officer · Trevi Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-29
Primary Completion
2018-12-03
Completion
2020-06-02
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018664 on ClinicalTrials.gov