Effects of Anticipation of Pain Relief on Brain Mechanisms

NCT00200876 | Completed DMC

• 1 other identifier: R01AT001415-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Placebo-induced activation of brain opioid neurotransmission

  90 min

Study Arms (2)

pain challenge

ACTIVE COMPARATOR

Procedure: Hypertonic saline; Procedure: Isotonic saline

non-painful control

SHAM COMPARATOR

Procedure: Hypertonic saline; Procedure: Isotonic saline

Interventions

Hypertonic saline PROCEDURE

To elicit pain

non-painful control; pain challenge

Isotonic saline PROCEDURE

Non-painful control

non-painful control; pain challenge

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to comply with all study requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jon-Kar Zubieta, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: September 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)