Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Drug: nalbuphine plus naloxone; Drug: nalbuphine plus saline; Drug: naloxone plus saline

• Registration Number: NCT00947284
• Lead Sponsor: University of California, San Francisco

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-28
• Study Start: 2010-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-08-14
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-21
• Results First Posted: 2013-10-23
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Women	naloxone plus saline	Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm.
Women	nalbuphine plus naloxone	Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm.
Women	nalbuphine plus saline	Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm.
Men	nalbuphine plus saline	Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm
Men	naloxone plus saline	Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm
Men	nalbuphine plus naloxone	Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm

Primary Outcome Measures

Name	Time	Method
Change in Skin Sensitivity as Measured by a Visual Analog Scale	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).

Trial Locations

Locations (1)

University of California; 🇺🇸 San Francisco, California, United States