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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 : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Brief Summary:
Healthy right-handed volunteers aged 21 to 50 needed for a research study of the effects of morphine and ketorolac on brain activity in response to pain stimuli as measured by functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). Study will be conducted on six separate days not requiring an overnight stay in the hospital.

Condition or disease Intervention/treatment Phase
Healthy Controls Radiation: Integrated MR-PET scan Drug: Ketorolac Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects
Actual Study Start Date : April 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Morphine condition Radiation: Integrated MR-PET scan
Integrated MR-PET scan using [11C]diprenorphine

Experimental: Ketorolac condition Radiation: Integrated MR-PET scan
Integrated MR-PET scan using [11C]diprenorphine

Drug: Ketorolac
3 administrations of ketorolac over course of study




Primary Outcome Measures :
  1. fMRI Signal Changes [ Time Frame: one day ]
    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.

  2. Pain Ratings [ Time Frame: One day ]
    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 class displaying how much time they had before receiving a painful stimuli ) and pain+glucose (subjects received a glucose injection accompanied by an injection schematic followed by a painful stimuli) within the morphine and ketorolac groups. We used the Gracely pain rating scale (ranging from 0, no sensation to 20, extremely painful.



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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male and female adults, aged 21-50
  2. No contraindications to fMRI scanning
  3. Within 15% of normal BMI
  4. Right handed (dominant hand is right hand)
  5. Have taken an opioid drug at least once in the past (for example, after a surgery)

Exclusion Criteria:

  1. Current or past history of major medical, neurological, or psychiatric illness
  2. Women who are pregnant or breast feeding, have gone through menopause, or have irregular menstrual cycles (length of cycle must be within 26 to 32 days)
  3. Contraindications to morphine administration:

    • i) Hypersensitivity to morphine or other phenanthrene-derivative opioid agonists (codeine, oxycodone, etc.), morphine salts, or any component of the product
    • ii) Concomitant use of other CNS depressants including antihistamines or alcohol
    • iii) History of drug or alcohol abuse
    • iv) History of head trauma
    • v) History of liver problems
    • vi) Pre-existing respiratory conditions (ex. COPD, asthma)
    • vii) Current use of any drugs that interact with morphine
  4. Contraindications to ketorolac administration

    • i) Allergic-type reaction, or urticaria in response to exposure to aspirin or other NSAIDS
    • ii) Concomitant aspirin or NSAID use
    • iii) Hypersensitivity previously demonstrated to ketorolac tromethamine or to any product component
    • iv) Peptic ulcer disease (active or history), or other gastrointestinal problems
    • vi) Current use of any drugs that interact with ketorolac (ex. heparin/warfarin)
    • vii) History of bleeding disorder
    • viii) Low body weight, under 50 kg
  5. Contraindications to fMRI scanning (including cardiac pacemaker, metal implants, claustrophobia, pregnancy)
  6. Contraindications to either of the emergency medications (Ondansetron or Narcan)
  7. History of head trauma
  8. High blood pressure (>140 systolic, >90 diastolic)
  9. History of impaired urinary elimination
  10. Major kidney problems, bleeding problems, severe dehydration, or recovering from a recent surgery (within past year).
  11. Instability of responses to experimental pain (see Study Procedures Section)
  12. History of asthma
  13. History of diabetes
  14. Liver Function Test results greater than 2.5 times the upper limit of normal (ULN) at Screening
  15. History of smoking (past or current)
  16. Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
  17. Non-fluent speaker of English
  18. Positive urine drug screen (i.e. positive on any of the 10 measures tested, including cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, barbiturates, benzodiazepines, methadone, and tricyclic antidepressants)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01576276


Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
  Study Documents (Full-Text)

Documents provided by Jian Kong, Massachusetts General Hospital:

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01576276     History of Changes
Other Study ID Numbers: 2011P000358
First Posted: April 12, 2012    Key Record Dates
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Morphine
Ketorolac
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action