Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00947284
• Other study ID #: NIH/NIDCR R01 DE018526-2
• Secondary ID: 5R01DE018526-02
• Status: Terminated
• Phase: N/A
• First received: July 1, 2009
• Last updated: May 19, 2016
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• nalbuphine plus naloxone
single dose administered intravenously
• nalbuphine plus saline
single dose administered intravenously
• naloxone plus saline
single dose administered intravenously

Locations

Country	Name	City	State
United States	University of California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Skin Sensitivity as Measured by a Visual Analog Scale	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	No