Healthy ControlsNCT01576276

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

A study testing Integrated MR-PET scan and Ketorolac in people with Healthy Controls, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Controls
What is being tested?: Integrated MR-PET scan and Ketorolac
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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)

Who cannot join

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

Show all 32Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Conditions: Healthy Controls
Being tested: Integrated MR-PET scan, Ketorolac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Integrated MR-PET scanRadiation
Integrated MR-PET scan using [11C]diprenorphine
KetorolacDrug
3 administrations of ketorolac over course of study

Study groups in NCT01576276
Study group	Role	What they receive
Morphine condition	Experimental	Not described Receives: Radiation: Integrated MR-PET scan
Ketorolac condition	Experimental	Not described Receives: Radiation: Integrated MR-PET scan; Drug: Ketorolac

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: One day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Feb 2017

First posted12 Apr 2012 (estimated)
Study startApr 2012
Primary completionFeb 2017
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ControlsStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01576276
Sponsor's protocol ID: 2011P000358
Status last verified: May 2018
First submitted: 24 Feb 2012
Last updated: 29 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects
ClinicalTrials.gov ID: NCT01576276
Acronym / sponsor ID: 2011P000358
Conditions: Healthy Controls
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Apr 2012 (actual)
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 12 Apr 2012 (estimated)
Results: Posted 29 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Morphine condition	Experimental	Radiation: Integrated MR-PET scan
Ketorolac condition	Experimental	Radiation: Integrated MR-PET scan, Drug: Ketorolac

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (32 listed)

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:
Contraindications to ketorolac administration
Contraindications to fMRI scanning (including cardiac pacemaker, metal implants, claustrophobia, pregnancy)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Integrated MR-PET scanIntegrated MR-PET scan using [11C]diprenorphine	Radiation	Ketorolac condition, Morphine condition
Ketorolac3 administrations of ketorolac over course of study	Drug	Ketorolac condition

Primary outcome

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.
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).

Results and safety

Results posted to the registry on 29 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Morphine Condition	22	14
Ketorolac Condition	29	18

Primary outcome: fMRI Signal Changes

Time frame: one day. Mean (Standard Deviation). Unit: Beta value

Measure	fMRI Signal Change n = 33
morphine injection cue at operculum	0.82 (0.79)
morphine control cue at operculum	0.43 (0.65)
ketorolac injection cue at operculum	-0.02 (0.46)
ketorolac control cue at operculum	0.55 (0.53)
ketorolac injection cue at insula	0.09 (0.42)
ketorolac control cue at insula	0.85 (0.92)

Population analysed: Here we present the average fMRI (functional MRI) signal changes of clusters that survived a threshold of 0.005 with10 continuous voxels. We only reported beta values in pain related areas.

Primary outcome: Pain Ratings

Time frame: One day. Mean (Standard Deviation). Unit: units on a scale

Measure	Morphine Condition n = 14	Ketorolac Condition n = 18
Value	-0.22 (1.45)	-0.97 (2.81)

Adverse events

Time frame: Adverse event data was collected for each participant over a 3 hours period (from time of drug administration until they left 3 hours later). We collected this for every participant throughout our study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Morphine Condition	0 of 22 (0%)	5 of 22 (22.7%)	0 of 22
Ketorolac Condition	0 of 29 (0%)	1 of 29 (3.4%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Integrated MR-PET scan and Ketorolac in people with Healthy Controls, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI Signal Changes (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01576276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.