A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects
Completed · Not applicable
Conditions studied: Healthy Controls
In brief
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.
Key facts
- Study ID
- NCT01576276
- Run by
- Massachusetts General Hospital
- People needed
- 51
- Starts
- 2012-04-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2018-06-29
Who can join
Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female adults, aged 21-50
- No contraindications to fMRI scanning
- Within 15% of normal BMI
- Right handed (dominant hand is right hand)
- Have taken an opioid drug at least once in the past (for example, after a surgery)
You may not qualify if…
- Current or past history of major medical, neurological, or psychiatric illness
- 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)
- 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
- 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
- Contraindications to fMRI scanning (including cardiac pacemaker, metal implants, claustrophobia, pregnancy)
- Contraindications to either of the emergency medications (Ondansetron or Narcan)
- History of head trauma
- High blood pressure (>140 systolic, >90 diastolic)
- History of impaired urinary elimination
- Major kidney problems, bleeding problems, severe dehydration, or recovering from a recent surgery (within past year).
- Instability of responses to experimental pain (see Study Procedures Section)
Where it is running
- Massachusetts General Hospital — Charlestown, Massachusetts, United States
Full record on ClinicalTrials.gov
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