Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

NCT00947284 | Terminated Results DMC

• 2 other identifiers: NIH/NIDCR R01 DE018526-25R01DE018526-02
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Women

EXPERIMENTAL

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; Drug: nalbuphine plus saline; Drug: naloxone plus saline

Men

EXPERIMENTAL

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; Drug: nalbuphine plus saline; Drug: naloxone plus saline

Interventions

nalbuphine plus naloxone DRUG

single dose administered intravenously

Also known as: Nubain, Narcan

Men; Women

nalbuphine plus saline DRUG

single dose administered intravenously

Also known as: Nubain

Men; Women

naloxone plus saline DRUG

single dose administered intravenously

Also known as: Narcan

Men; Women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Nalbuphine; Naloxone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The lead investigator passed away and co-investigators could not find complete data on his computer. The experimental model for skin sensitivity did not work in the first 3 participants, and the study was terminated without collecting outcomes data.

Results Point of Contact

• Title: Jon Levine MD, PhD
• Organization: UCaliforniaSF

jon.levine@ucsf.edu

415-476-5108

Study Officials

• Jon D Levine, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 28, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 20, 2016
• Results First Posted: October 23, 2013

Record last verified: 2013-10

Locations

US (1)