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NCT01576276
A Brain Imaging Study of Opioid (Morphine) and Non-opioid (Ketorolac) Conditioning Effects
NA trial testing Integrated MR-PET scan in Healthy Controls in 51 participants. Completed in 1 February 2017.
1 February 2017
Quick facts
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | other |
| Enrollment | 51 |
| Start date | 1 April 2012 |
| Primary completion | 1 February 2017 |
| Estimated completion | 1 February 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Integrated MR-PET scan
- Ketorolac (KETOROLAC) — full drug profile →
Conditions studied
- Healthy Controls — all drugs for Healthy Controls →
Sponsor
Massachusetts General Hospital
Who can join
Adults 21 to 50, any sex, with Healthy Controls. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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 schemati
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01576276
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01576276 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
- Last refreshed: 29 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01576276.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing