Trial Outcomes & Findings for Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil (NCT NCT00991809)

Last Updated: 2017-10-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

8 sessions over 4-6 weeks

Results posted on

2017-10-06

Participant Flow

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).

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)

Participant milestones

Participant milestones
Measure	Alfentanil 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)	Diphenhydramine 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
Overall Study STARTED	12	10
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alfentanil n=12 Participants 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	Diphenhydramine n=10 Participants 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 n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 sessions over 4-6 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Alfentanil n=8 Participants 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	Diphenhydramine n=3 Participants 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
Pain Tolerance	105.3 seconds Interval 10.5 to 300.0	19.2 seconds Interval 7.1 to 38.7

SECONDARY outcome

Timeframe: 8 sessions over 4-6 weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Alfentanil n=8 Participants 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	Diphenhydramine n=3 Participants 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
Pain Threshold	20.7 seconds Interval 4.6 to 73.6	8.6 seconds Interval 4.4 to 22.5

Adverse Events

Alfentanil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diphenhydramine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. D. Andrew Tompkins

Johns Hopkins University, School of Medicine

Phone: 410-550-5953

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place