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Completed

NCT Number: NCT00200876

Effects of Anticipation of Pain Relief on Brain Mechanisms

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.

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Key information

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline

Procedure

To elicit pain

Isotonic saline

Procedure

Non-painful control

Primary outcomes

  1. Placebo-induced activation of brain opioid neurotransmission

    Time frame: 90 min

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Neurochemical Mediation of Placebo Responses in Humans

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 20, 2005
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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