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Completed

NCT Number: NCT01576276

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

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.

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • History of asthma
  • History of diabetes
  • Liver Function Test results greater than 2.5 times the upper limit of normal (ULN) at Screening
  • History of smoking (past or current)
  • Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
  • Non-fluent speaker of English
  • 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)

Treatment and study plan

Integrated MR-PET scan

Radiation

Integrated MR-PET scan using [11C]diprenorphine

Ketorolac

Drug

3 administrations of ketorolac over course of study

Primary outcomes

  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 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2012
Registry last updated
Jun 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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