Placebo In Chronic Pain
This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and non-responders, and these differences are PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical utility and that its properties can be studied by human brain imaging techniques. In Phase I of the study, the investigators seek to identify brain imaging parameters that predict the propensity for the placebo response in an independent CBP cohort. In Phase II, the investigators will evaluate the interaction between placebo response and medication treatment in individuals stratified as placebo responders versus non-responders. This research is designed to critically assess the neurobiology of placebo analgesia for chronic pain in a double-blind clinical trial.
Chronic Back Pain
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||BRAIN MECHANISMS FOR CLINICAL PLACEBO IN CHRONIC PAIN: A Double-Blind Randomized Clinical Trial of Placebo and Chronic Back Pain|
- VAS pain scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
No Intervention: Observational
Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study.
Active Comparator: Naproxen & Omeprazole
Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study.
Take one 500mg naproxen capsule twice a day.
Other Names:Drug: Omeprazole
Take one 40mg omeprazole capsule twice a day.
Placebo Comparator: Placebo Only
Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study.
Take one placebo capsule twice a day.
Other Name: Sugar Pill
Please refer to this study by its ClinicalTrials.gov identifier: NCT02013427
|Contact: Etienne Vachon-Presseau, PhDemail@example.com|
|Contact: Sara E Berger, BA, PhD Candidatefirstname.lastname@example.org|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Etienne Vachon-Presseau, PhD 312-503-3039 email@example.com|
|Contact: Sara E Berger, BA, PhD Candidate 312-503-1703 firstname.lastname@example.org|
|Principal Investigator: Apkar Apkarian, PhD|
|Sub-Investigator: Todd B Parrish, PhD|
|Sub-Investigator: Thomas J Schnitzer, MD, PhD|
|Sub-Investigator: David Cella, PhD|
|Sub-Investigator: Richard Gershon, PhD|
|Sub-Investigator: David C Mohr, PhD|
|Principal Investigator:||Apkar Apkarian, PhD||Northwestern University Feinberg School of Medicine|