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Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

This study has been terminated.
(Experimental pain model didn't work as anticipated.)
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00947284
First received: July 1, 2009
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Healthy
 Drug: nalbuphine plus naloxone
Drug: nalbuphine plus saline
Drug: naloxone plus saline

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in skin sensitivity as measured by a visual analog scale [ Time Frame: Prior to drug administration and at three times after drug administration: 20 minutes, 70 minutes and 2 hours. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947284

Locations
United States, California
University of California
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jon D Levine, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Jon D. Levine, MD, PhD, Professor, University of California, San Fancisco
ClinicalTrials.gov Identifier: NCT00947284     History of Changes
Other Study ID Numbers: NIH/NIDCR R01 DE018526-2, NIH/NIDCR R01 DE018526
Study First Received: July 1, 2009
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nalbuphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 23, 2013