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Effects of Anticipation of Pain Relief on Brain Mechanisms

Neurochemical Mediation of Placebo Responses in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00200876
Enrollment
60
Registered
2005-09-20
Start date
2003-09-30
Completion date
2008-06-30
Last updated
2017-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Positron-Emission Tomography, Endorphins, Pain Relief, Opioid Receptors, Stress, Analgesia

Brief summary

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.

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.

Interventions

PROCEDUREHypertonic saline

To elicit pain

PROCEDUREIsotonic saline

Non-painful control

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Hypertonic saline is a challenge to activate endogenous opioid systems as assessed with positron emission tomography. There is no treatment involved. Isotonic saline is the control.

Eligibility

Sex/Gender
ALL
Age
20 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Placebo-induced activation of brain opioid neurotransmission90 min

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026