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Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947284
Recruitment Status : Terminated (Experimental pain model didn't work as anticipated.)
First Posted : July 28, 2009
Results First Posted : October 23, 2013
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: nalbuphine plus naloxone Drug: nalbuphine plus saline Drug: naloxone plus saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model
Study Start Date : January 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • Nubain
  • Narcan

Drug: nalbuphine plus saline
single dose administered intravenously
Other Name: Nubain

Drug: naloxone plus saline
single dose administered intravenously
Other Name: 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:
  • Nubain
  • Narcan

Drug: nalbuphine plus saline
single dose administered intravenously
Other Name: Nubain

Drug: naloxone plus saline
single dose administered intravenously
Other Name: Narcan


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947284


Locations
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United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jon D Levine, MD, PhD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00947284    
Other Study ID Numbers: NIH/NIDCR R01 DE018526-2
5R01DE018526-02 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2009    Key Record Dates
Results First Posted: October 23, 2013
Last Update Posted: May 20, 2016
Last Verified: October 2013
Additional relevant MeSH terms:
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Nalbuphine
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics