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

NCT ID: NCT01576276

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2017-02-28

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.

Conditions

Healthy Controls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Morphine condition

Group Type: EXPERIMENTAL

Integrated MR-PET scan

Intervention Type: RADIATION

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

Ketorolac condition

Group Type: EXPERIMENTAL

Integrated MR-PET scan

Intervention Type: RADIATION

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

Ketorolac

Intervention Type: DRUG

3 administrations of ketorolac over course of study

Interventions

Integrated MR-PET scan

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

Intervention Type: RADIATION

Ketorolac

3 administrations of ketorolac over course of study

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Kong

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2011P000358

Identifier Type: -

Identifier Source: org_study_id