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

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy
• Interventions: Drug: nalbuphine plus naloxone; Drug: nalbuphine plus saline; Drug: naloxone plus saline
• Enrollment: 3

Participant Flow

Recruitment Details	Recruitment details unavailable due to death of investigator
Pre-assignment Details	Pre-assignment details unavailable due to death of investigator

Arm/Group Title	Women-all Three Combinations	Men-all Three Combinations
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	0	3
Completed	0	0
Not Completed	0	3

Baseline Characteristics

Arm/Group Title		Men-all Three Combinations
Arm/Group Description		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.
Overall Number of Baseline Participants		3
Baseline Analysis Population Description		[Not Specified]
Age, Customized [1]; Measure Type: Number; Unit of measure: Participants
Unknown	Number Analyzed	3 participants
		3
		[1] Measure Description: Demographic data not available due to death of investigator; co-investigators searched the computer of the deceased investigator and cannot find additional data
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants
	Female	0 0.0%
	Male	3 100.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	3 participants
		3

Outcome Measures

1. Primary Outcome

Title	Change in Skin Sensitivity as Measured by a Visual Analog Scale
Description	Participants would have been asked to rate the level of pain on a scale from 0 (no pain) to 10 (worst pain imaginable).
Time Frame	Prior to drug administration and 20 minutes, 70 minutes and 2 hours after each drug administration

Outcome Measure Data

Analysis Population Description

The planned model of skin irritation could not be reproduced on 3 enrolled participants, thus the investigator did not obtain outcome data.

Arm/Group Title	Men-all Three Combinations
Arm/Group Description:	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.
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	1 day
Adverse Event Reporting Description	The lead investigator passed away and co-investigators could not find adverse event 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.
Arm/Group Title	Men-all Three Combinations
Arm/Group Description	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.
All-Cause Mortality
	Men-all Three Combinations
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Men-all Three Combinations
	Affected / at Risk (%)
Total	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Men-all Three Combinations
	Affected / at Risk (%)
Total	0/0

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Jon Levine MD, PhD
• Organization: UCaliforniaSF
• Phone: 415-476-5108
• EMail: jon.levine@ucsf.edu

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00947284
• Other Study ID Numbers: NIH/NIDCR R01 DE018526-2; 5R01DE018526-02 ( U.S. NIH Grant/Contract )
• First Submitted: July 1, 2009
• First Posted: July 28, 2009
• Results First Submitted: August 14, 2013
• Results First Posted: October 23, 2013
• Last Update Posted: May 20, 2016