Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

May 19, 2016 updated by: University of California, San Francisco

Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 - 40
  • In stable health
  • Speak, read, understand English language
  • If female, must be non-lactating and not pregnant

Exclusion Criteria:

  • Heat pain detection thresholds above 47 ºC/116.6 ºF
  • Inability to develop secondary hyperalgesia from the heat and capsaicin stimulation performed at the screening visit
  • Serious psychiatric psychopathology (psychotic disorder, substance abuse)
  • Tattoos in the area of measurements
  • Allergy to study drugs (nalbuphine, naloxone, or capsaicin)
  • Current or recent use opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women
Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm.
Drug: nalbuphine plus naloxone
single dose administered intravenously
Other Names:
  • Narcan
  • Nubain
Drug: nalbuphine plus saline
single dose administered intravenously
Other Names:
  • Nubain
Drug: naloxone plus saline
single dose administered intravenously
Other Names:
  • Narcan
Experimental: Men
Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm
Drug: nalbuphine plus naloxone
single dose administered intravenously
Other Names:
  • Narcan
  • Nubain
Drug: nalbuphine plus saline
single dose administered intravenously
Other Names:
  • Nubain
Drug: naloxone plus saline
single dose administered intravenously
Other Names:
  • Narcan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Sensitivity as Measured by a Visual Analog Scale
Time Frame: Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration
Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIH/NIDCR R01 DE018526-2
  • 5R01DE018526-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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