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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01576276
First received: February 24, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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 Intervention
Healthy Controls
Radiation: Integrated MR-PET scan
Drug: Ketorolac
Drug: Morphine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • PET and fMRI signal changes [ Time Frame: one day ] [ Designated as safety issue: No ]
    Obtain information about brain activity (including BOLD signal and opioid binding potential) using an integrated PET & fMRI system

  • Pain ratings [ Time Frame: 5 sessions involving pain ratings ] [ Designated as safety issue: No ]
    Characterize analgesic response to morphine and ketorolac using pain ratings


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine condition Radiation: Integrated MR-PET scan
Integrated MR-PET scan using [11C]diprenorphine
Drug: Morphine
3 administrations of morphine over course of study
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
Experimental: Pilot
MRI-only
Drug: Ketorolac
3 administrations of ketorolac over course of study
Drug: Morphine
3 administrations of morphine over course of study

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576276

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Daniel Ott, BS    617-726-5004    dott@partners.org   
Principal Investigator: Jian Kong         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01576276     History of Changes
Other Study ID Numbers: 2011P000358
Study First Received: February 24, 2012
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 30, 2014