Overview

This trial is active, not recruiting.

Conditions migraine, healthy
Treatment placebo
Phase phase 2
Sponsor Massachusetts General Hospital
Collaborator National Institutes of Health (NIH)
Start date March 2013
End date April 2014
Trial size 28 participants
Trial identifier NCT01970943, AT007530-01, R21AT007530-01

Summary

The placebo effect is a phenomenon that has experienced major advances of its understanding in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have yet to be compared to healthy subjects. The investigators study aims to investigate the magnitude of placebo response and related opioid release in patients that suffer from episodic migraines as compared to healthy controls. In particular, the investigators are looking to map brain activity during placebo analgesia using modern brain imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). The investigators hypothesis is that placebo response and the availability of opioid receptors is reduced in chronic migraine patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(No Intervention)
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
(Placebo Comparator)
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
placebo
Placebo will be compared to No Intervention.

Primary Outcomes

Measure
VAS Pain rating
time frame: 1 day

Secondary Outcomes

Measure
fMRI BOLD signal
time frame: 1 day
PET Diprenorphine
time frame: 1 day

Eligibility Criteria

Male or female participants from 21 years up to 50 years old.

Inclusion Criteria: - Migraine patients with aura with acute episodic migraine meeting the IHS Classification ICHD-II criteria, 3-14 migraines per month. - History of episodic migraine for at least 3 years - Ages 21-50 - Male or Female - Right Handed Matched healthy subjects will also be recruited. Exclusion Criteria: - Other significant disease (systemic or CNS) - Pregnancy - Claustrophobia - Weight >235 lbs (limit of MRI table) - Significant drug including alcohol history (> 7 glasses of alcohol per week) - Beck Depression Inventory II (BDI-II) score > 25 (moderate to severe depression) - Any metal implants incompatible with MRI (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, IUDs, aneurysm clips or other devices, tattoos containing metallic ink, cardiac pacemakers, prosthetic hear valves, other prostheses, neurostimulator devices, implanted infusion pumps, exposure to shrapnel or metal filings, cochlear implants, etc.) - Previous significant research related exposure to ionizing radiation. - History of allergy or adverse reaction to opioids - Significant medical history of such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc. - Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.) - Patients with migraine <72 hours prior to the experiments will not be included to ensure inter-ictal state. - Opioids or preventative medication such as topiramate, SSRIs etc.

Additional Information

Official title Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Principal investigator David Borsook, MD, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.