Placebo In Chronic Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Northwestern University
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University Identifier:
First received: December 9, 2013
Last updated: April 15, 2014
Last verified: April 2014

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.

Condition Intervention Phase
Chronic Back Pain
Drug: Naproxen
Drug: Placebo
Drug: Omeprazole
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • VAS pain scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
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)
Arms Assigned Interventions
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.
Drug: Naproxen
Take one 500mg naproxen capsule twice a day.
Other Names:
  • Aleve
  • Anaprox
  • Antalgin
  • Apranax
  • Feminax Ultra
  • Flanax
  • Inza
  • Midol Extended Relief
  • Nalgesin
  • Naposin
  • Naprelan
  • Naprogesic
  • Naprosyn
  • Narocin
  • Proxen
  • Soproxen
  • Synflex
  • Xenobid
Drug: Omeprazole
Take one 40mg omeprazole capsule twice a day.
Other Names:
  • Prilosec
  • losepine
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.
Drug: Placebo
Take one placebo capsule twice a day.
Other Name: Sugar Pill


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • History of low back pain for a minimum of 6 months with signs and symptoms of radiculopathy: positive straight leg raising test with dermatomal radiation and/or myotomal weakness and/or reflex asymmetry; pain must radiate into buttock or below.
  • Male or female, age greater than18 years, with no racial/ethnic restrictions.
  • Must have a Visual Analog Scale (VAS) pain score >50 mm (of 100 mm maximum) at the baseline visit (for which 0mm = no pain, and 100 mm = worst pain imaginable).
  • Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires.
  • Must be in generally stable health.
  • Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate.

Exclusion Criteria:

  • Low back pain associated with any systemic signs or symptoms, e.g., fever, chills.
  • Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor in the back.
  • Other comorbid chronic pain or neurological conditions.
  • Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of their low back pain.
  • Diagnosis of current depression or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months.
  • Beck Depression Inventory II score of >28.
  • Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed).
  • Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy.
  • History of gastrointestinal ulcer during the past year.
  • History of myocardial infarction in the past year.
  • Uncontrolled hypertension.
  • Renal insufficiency.
  • Allergic to, or non-tolerant of, NSAIDs.
  • History of aspirin-sensitive asthma.
  • Regular use of low dose aspirin.
  • Current use of recreational drugs or history of alcohol or drug abuse.
  • Any change in medication for back pain in the last 30 days.
  • High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day.
  • Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk.
  • In the judgment of the investigator, unable or unwilling to follow protocol and instructions.
  • Evidence of poor treatment compliance, in the judgment of the investigator.
  • Intra-axial implants (e.g. spinal cord stimulators or pumps).
  • All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia.
  • Pregnancy, or inability to use an effective form of contraception in women of child-bearing age.
  • Diabetes (Type I or Type II).

Prohibited Medications:

  • Therapeutic doses of antidepressant medications (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed).
  • Oral iron supplementation unless approved by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02013427

Contact: Etienne Vachon-Presseau, PhD 312-503-3039
Contact: Sara E Berger, BA, PhD Candidate 312-503-1703

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   
Contact: Sara E Berger, BA, PhD Candidate    312-503-1703   
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         
Sponsors and Collaborators
Northwestern University
Principal Investigator: Apkar Apkarian, PhD Northwestern University Feinberg School of Medicine
  More Information

No publications provided

Responsible Party: Apkar Apkarian, Professor, Northwestern University Identifier: NCT02013427     History of Changes
Other Study ID Numbers: STU00080585, R01AT007987-01A1
Study First Received: December 9, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Northwestern University:

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on September 16, 2014