Effects of Anticipation of Pain Relief on Brain Mechanisms

NCT ID: NCT00200876

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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pain challenge

Group Type ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type PROCEDURE

To elicit pain

Isotonic saline

Intervention Type PROCEDURE

Non-painful control

non-painful control

Group Type SHAM_COMPARATOR

Hypertonic saline

Intervention Type PROCEDURE

To elicit pain

Isotonic saline

Intervention Type PROCEDURE

Non-painful control

Interventions

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Hypertonic saline

To elicit pain

Intervention Type PROCEDURE

Isotonic saline

Non-painful control

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Jon-Kar Zubieta

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jon-Kar Zubieta, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R01AT001415-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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R01AT001415-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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