Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

• ClinicalTrials.gov Identifier: NCT00947284
• Recruitment Status: Terminated
• First Posted: July 28, 2009
• Results First Posted: October 23, 2013
• Last Update Posted: May 20, 2016
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: July 1, 2009
• First Posted Date: July 28, 2009
• Results First Submitted Date: August 14, 2013
• Results First Posted Date: October 23, 2013
• Last Update Posted Date: May 20, 2016
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 21, 2013)

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).

• Original Primary Outcome Measures (submitted: July 24, 2009): 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. ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity
• Official Title: Effect of Kappa Opioid Agonist-Antagonists in the Heat/Capsaicin Sensitization Model
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

Study Arms

• 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.
  Interventions:

  • Drug: nalbuphine plus naloxone
  • Drug: nalbuphine plus saline
  • Drug: naloxone plus saline
• 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
  Interventions:

  • Drug: nalbuphine plus naloxone
  • Drug: nalbuphine plus saline
  • Drug: naloxone plus saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 21, 2013): 3
• Original Estimated Enrollment (submitted: July 24, 2009): 30
• Actual Study Completion Date: June 2012
• Actual Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00947284
• Other Study ID Numbers: NIH/NIDCR R01 DE018526-2; 5R01DE018526-02 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Jon D. Levine, MD, PhD, Professor, University of California, San Fancisco
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jon D Levine, MD, PhD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: October 2013