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

NCT01576276 | Completed Results DMC

• 1 other identifier: 2011P000358
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• fMRI Signal Changes

  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.

  one day

• Pain Ratings

  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).

  One day

Study Arms (2)

Morphine condition

EXPERIMENTAL

Radiation: Integrated MR-PET scan

Ketorolac condition

EXPERIMENTAL

Radiation: Integrated MR-PET scan; Drug: Ketorolac

Interventions

Integrated MR-PET scan RADIATION

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

Ketorolac condition; Morphine condition

Ketorolac DRUG

3 administrations of ketorolac over course of study

Ketorolac condition

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Interventions

Ketorolac

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jian Kong
• Organization: Massachusetts General Hospital

jkong2@mgh.harvard.edu

617-726-7893

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2012
• First Posted: April 12, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2018-05

Locations

US (1)