Effect of Nalbuphine and Naloxone on Experimentally Induced Skin Sensitivity

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00947284

NIH/NIDCR R01 DE018526-2

5R01DE018526-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 2 patient groups

Women

Experimental group

Description:

Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm.

Treatment:

Drug: nalbuphine plus saline

Drug: nalbuphine plus naloxone

Drug: naloxone plus saline

Men

Experimental group

Description:

Both arms of this study will receive identical interventions. The only difference will be the sex of the participants in each study arm

Treatment:

Drug: nalbuphine plus saline

Drug: nalbuphine plus naloxone

Drug: naloxone plus saline