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NCT00947284 · ClinicalTrials.gov registry record · NA

Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

A NA study, sponsored by University of California, San Francisco.

Terminated
Registry status
NA
Development phase
3
Enrollment target

NCT00947284: Clinical Trial NA study, sponsored by University of California, San Francisco.

NCT00947284 is a NA study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 3 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00947284, a NA study, was terminated before completion, sponsored by University of California, San Francisco.

TERMINATED
Registry status
NA
Development phase
3 participants
Enrollment target

Study Summary

In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The purpose of this study is to find out if nalbuphine combined with naloxone is more effective in relieving experimentally produced pain than either drug alone. A second reason for this study is to find out if study medications work more effectively in women or in men. Subjects will come to the University of California at San Francisco (UCSF) Clinical Research Center (CRC) for 4 study visits. The first visit will be a 2-hour screening to assess the subject for study eligibility. During the other three visits, the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.

Primary Outcome

Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).

Interventions

  • DRUG nalbuphine plus naloxone
  • DRUG nalbuphine plus saline
  • DRUG naloxone plus saline

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2010-01
Est. Completion 2012-06
Phase NA

Why NCT00947284 stopped before completion

NCT00947284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 3 interventions - of which nalbuphine plus naloxone is the first listed.

NCT00947284 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00947284 about?

NCT00947284 is a clinical study titled "Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity". In previous clinical studies of post-surgical pain the investigators found that nalbuphine (Nubain), a narcotic pain killer, relieves pain more effectively when combined with low-dose naloxone (Narcan), a drug that is used to treat narcotic overdose. This finding was particularly true in men. The pu...

What is the current status of trial NCT00947284?

This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2010-01. Estimated completion is 2012-06.

What interventions are being tested in trial NCT00947284?

The interventions under investigation include: nalbuphine plus naloxone (DRUG), nalbuphine plus saline (DRUG), naloxone plus saline (DRUG).

Who is sponsoring clinical trial NCT00947284?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00947284's enrollment target sits among peer trials

3 1996th of 2000 higher than 4 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00947284, the US trial registry maintained by the National Library of Medicine. NCT00947284 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.