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Trial record 27 of 448 for:    diphenhydramine

Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil (0813)

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ClinicalTrials.gov Identifier: NCT00991809
Recruitment Status : Completed
First Posted : October 8, 2009
Results First Posted : October 14, 2013
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Hyperalgesia
Interventions Drug: Alfentanil
Drug: Diphenhydramine
Enrollment 22
Recruitment Details Study enrollment began in February 2009 after Institutional Review Board (IRB) approval. Screening started on 2/9/09. The last person was screened on 3/12/2010 and finished the study in April 2010. A total of 42 screenings occurred and 12 persons completed the study. Recruitment was conducted at the Behavioral Pharmacology Research Unit (BPRU).
Pre-assignment Details Since study initiation in February 2009, there were 42 persons consented. There were 13 screen failures [4 had urines positive for illicit substances, 4 had BMI>30, 5 had active medical problems]. Seven met study criteria but decided not to start as they could not commit to study schedule (N=6) or did not like blood draws (N=1)
Arm/Group Title Alfentanil Diphenhydramine
Hide Arm/Group Description

Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg intramuscular(IM)

Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM

Period Title: Overall Study
Started 12 10
Completed 8 4
Not Completed 4 6
Arm/Group Title Alfentanil Diphenhydramine Total
Hide Arm/Group Description

These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg IM

Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM

Total of all reporting groups
Overall Number of Baseline Participants 12 10 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
10
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
10
 100.0%
22
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  10.0%
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  33.3%
4
  40.0%
8
  36.4%
White
6
  50.0%
5
  50.0%
11
  50.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  16.7%
0
   0.0%
2
   9.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 22 participants
12 10 22
1.Primary Outcome
Title Pain Tolerance
Hide Description The participant places their hand in a water bath kept at 4 degrees Celsius (cold pressor test). They then continue to hold the hand in the water bath until they can no longer tolerate the pain (pain tolerance) or until the end of the testing (truncated at 300 seconds for safety purposes). Reported as the mean (time to hand removal in seconds) at the 30 minute time point.
Time Frame 8 sessions over 4-6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.
Arm/Group Title Alfentanil Diphenhydramine
Hide Arm/Group Description:

These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg IM

Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM

Overall Number of Participants Analyzed 8 3
Mean (Full Range)
Unit of Measure: seconds
105.3
(10.5 to 300)
19.2
(7.1 to 38.7)
2.Secondary Outcome
Title Pain Threshold
Hide Description The amount of time (in seconds) before the participant first verbally reports feeling pain after placing hand in 4 degree Celsius circulating water bath at the 30 minute time point. Truncated at 300 seconds for safety purposes.
Time Frame 8 sessions over 4-6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
One person in the diphenhydramine group was dropped from analysis, even though he completed the study as he tolerated cold pressor testing for the maximum amount of time in sessions 2-8.
Arm/Group Title Alfentanil Diphenhydramine
Hide Arm/Group Description:

These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil: 15 mcg/kg IM

Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine: 25 mg IM

Overall Number of Participants Analyzed 8 3
Mean (Full Range)
Unit of Measure: seconds
20.7
(4.6 to 73.6)
8.6
(4.4 to 22.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Alfentanil Diphenhydramine
Hide Arm/Group Description

These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Alfentanil : 15 mcg/kg IM

Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Diphenhydramine : 25 mg IM

All-Cause Mortality
Alfentanil Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Alfentanil Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alfentanil Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/10 (0.00%) 
The sample size was intentionally small as this was to be a preliminary proof-of-concept step in the development of a human OIH model.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. D. Andrew Tompkins
Organization: Johns Hopkins University, School of Medicine
Phone: 410-550-5953
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00991809     History of Changes
Other Study ID Numbers: NA_00022154
1K24DA023186 ( U.S. NIH Grant/Contract )
First Submitted: October 7, 2009
First Posted: October 8, 2009
Results First Submitted: August 9, 2013
Results First Posted: October 14, 2013
Last Update Posted: October 6, 2017