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A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects

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ClinicalTrials.gov Identifier: NCT01576276
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : May 28, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Healthy Controls
Interventions Radiation: Integrated MR-PET scan
Drug: Ketorolac
Enrollment 51
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Morphine Condition Ketorolac Condition
Hide Arm/Group Description

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Morphine: 3 administrations of morphine over course of study

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Ketorolac: 3 administrations of ketorolac over course of study

Period Title: Overall Study
Started 22 29
Completed 14 18
Not Completed 8 11
Arm/Group Title Morphine Condition Ketorolac Condition Total
Hide Arm/Group Description

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Morphine: 3 administrations of morphine over course of study

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Ketorolac: 3 administrations of ketorolac over course of study

Total of all reporting groups
Overall Number of Baseline Participants 22 29 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 29 participants 51 participants
25.0  (3.3) 26.0  (4.9) 25.5  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
Female
5
  22.7%
7
  24.1%
12
  23.5%
Male
17
  77.3%
22
  75.9%
39
  76.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
Hispanic or Latino
1
   4.5%
2
   6.9%
3
   5.9%
Not Hispanic or Latino
19
  86.4%
26
  89.7%
45
  88.2%
Unknown or Not Reported
2
   9.1%
1
   3.4%
3
   5.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 29 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
  13.6%
1
   3.4%
4
   7.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   4.5%
1
   3.4%
2
   3.9%
White
18
  81.8%
23
  79.3%
41
  80.4%
More than one race
0
   0.0%
3
  10.3%
3
   5.9%
Unknown or Not Reported
0
   0.0%
1
   3.4%
1
   2.0%
Pain Ratings   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 14 participants 18 participants 32 participants
10.9  (2.6) 11.6  (2.2) 11.3  (2.4)
[1]
Measure Analysis Population Description: Some subjects were dropped before or during the MRI scan in which baseline pain ratings were collected. We used the Gracely Sensory Pain Scale (0-20; 0: no pain, 20: intolerable pain) to rate the pain subject's experienced.
1.Primary Outcome
Title fMRI Signal Changes
Hide Description Obtain information about brain activity, including BOLD (Blood-oxygen-level dependent) signal, using an fMRI system. Data analysis was applied using SPM 12 with a standard pipeline.
Time Frame one day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Here we present the average fMRI (functional MRI) signal changes of clusters that survived a threshold of 0.005 with10 continuous voxels. We only reported beta values in pain related areas.
Arm/Group Title fMRI Signal Change
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We used SPM 12 to analyze the data, and compared the fMRI signal change during pressure pain between 1. morphine injection cue vs. control cue, 2. ketorolac injection cue vs. control cue. A threshold of p < 0.005 with 10 continuous voxels was applied.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: Beta value
morphine injection cue at operculum 0.82  (0.79)
morphine control cue at operculum 0.43  (0.65)
ketorolac injection cue at operculum -0.02  (0.46)
ketorolac control cue at operculum 0.55  (0.53)
ketorolac injection cue at insula 0.09  (0.42)
ketorolac control cue at insula 0.85  (0.92)
2.Primary Outcome
Title Pain Ratings
Hide Description The primary endpoint was the morphine and ketorolac conditioning effects as indicated by subjective pain rating changes between pain only (a control condition with no injection of glucose, but subject's did see an image of an hour glass displaying how much time they had before receiving a painful stimulus) and pain+glucose (subjects received a glucose injection accompanied by an injection schematic followed by a painful stimulus) within the morphine and ketorolac groups. We used the Gracely pain rating scale (ranging from 0, no sensation to 20, extremely painful).
Time Frame One day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Morphine Condition Ketorolac Condition
Hide Arm/Group Description:

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Morphine: 3 administrations of morphine over course of study

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Ketorolac: 3 administrations of ketorolac over course of study

Overall Number of Participants Analyzed 14 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.22  (1.45) -0.97  (2.81)
Time Frame Adverse event data was collected for each participant over a 3 hours period (from time of drug administration until they left 3 hours later). We collected this for every participant throughout our study.
Adverse Event Reporting Description Our definitions are consistent. After every drug administration we asked a standard questionnaire, which we also asked again a couple of hours following the initial drug administration. Specifically, we asked subjects if they felt nauseous, indigestion, itching, spacey/drugged, lightheadedness/faint, sense of difficulty concentrating, or sleepy.
 
Arm/Group Title Morphine Condition Ketorolac Condition
Hide Arm/Group Description

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Morphine: 3 administrations of morphine over course of study

Integrated MR-PET scan: Integrated MR-PET scan using [11C]diprenorphine

Ketorolac: 3 administrations of ketorolac over course of study

All-Cause Mortality
Morphine Condition Ketorolac Condition
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Morphine Condition Ketorolac Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/29 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Morphine Condition Ketorolac Condition
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/22 (22.73%)      1/29 (3.45%)    
Surgical and medical procedures     
Drug related reactions * [1]  5/22 (22.73%)  5 1/29 (3.45%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Drug related reactions to morphine and ketorolac, including feeling nauseous, spacey, and drugged.
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. Jian Kong
Organization: Massachusetts General Hospital
Phone: 617-726-7893
Responsible Party: Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01576276     History of Changes
Other Study ID Numbers: 2011P000358
First Submitted: February 24, 2012
First Posted: April 12, 2012
Results First Submitted: February 8, 2018
Results First Posted: May 28, 2018
Last Update Posted: June 29, 2018