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Effects of Anticipation of Pain Relief on Brain Mechanisms
This study has been completed.
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00200876
  Purpose

This study will use brain imaging technology to examine chemical systems in the brain that suppress pain and stress when an individual has an expectation of pain relief.


Condition Intervention
Pain
Drug: Hypertonic saline
Drug: Isotonic saline

U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Neurochemical Mediation of Placebo Responses in Humans

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Placebo-induced activation of brain opioid neurotransmission

Enrollment: 60
Study Start Date: September 2003
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Evidence suggests that the expectation of pain relief, even if a person receives only a placebo, can provide actual therapeutic benefits. The µ-opioid receptor system, located in the brain, is activated during anticipation of pain relief; this activation suppresses stress and pain responses. This study will use brain imaging technology to examine the effects of a placebo intervention on µ-opioid neurotransmitters. Examination of the factors that regulate these placebo-activated neurotransmitter responses will clarify the overall neurobiology underlying variations in the responses to placebos, as well as pain and other stressful conditions, ultimately leading to the optimization of medical and psychological interventions.

This study will last several hours during one study visit. Participants will receive both a painful and a painless injection while undergoing positron emission tomography (PET) brain imaging. The painful injection will consist of small amounts of hypertoninc saline (concentrated saline that causes cell shrinkage) in the jaw muscle over a 20-minute period. Several minutes after participants receive hypertonic saline, they will receive an injection with isotonic saline not associated with pain in the opposite jaw muscle. After participants receive the injections, they will either be told or not be told about a pain relief intervention. PET imaging will continue as participants either anticipate or do not anticipate pain relief. Participants will be asked about their pain levels repeatedly throughout the study; their responses will be entered into a computer-controlled system which will modulate rates of saline infusion.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to comply with all study requirements

Exclusion Criteria:

  • Presence of pain at study entry
  • Personal or first-degree (e.g., mother, father, sister, brother) family history of neurologic or psychiatric disorders
  • History of substance abuse or dependence
  • Left-handed or ambidextrous
  • Positive urine toxicology screen
  • Acute or uncorrected medical illness that may interfere with the study
  • Unable to tolerate brain scanning procedures
  • Current treatment with antipsychotics, mood stabilizers, isoniazid (a drug for tuberculosis [TB]), glucocorticoids/mineralocorticoids, psychostimulant appetite suppressants, or centrally active antihypertensive drugs
  • Treatment with hormones, antidepressants, or opioids within 6 months prior to study entry
  • Treatment with sedative hypnotic medications or over-the-counter sleeping aids within 1 month prior to study entry
  • Diagnosis of depression
  • Competitive exercise, or exercise exceeding 1 hour each day
  • Regular smoking within 5 years prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200876

Locations
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Investigators
Principal Investigator: Jon-Kar Zubieta, MD, PhD University of Michigan
  More Information

Study ID Numbers: R01 AT001415-01A1
Study First Received: September 13, 2005
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00200876  
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Positron-Emission Tomography
Endorphins
Pain Relief
Opioid Receptors
Stress
Analgesia

Study placed in the following topic categories:
Stress
Pain

ClinicalTrials.gov processed this record on January 16, 2009