Sensory and Opioid Mechanisms of Affective Touch

Summary

Background:

Medicines called opioids are used to treat pain. The body also produces opioids. These are called endorphins. Researchers want to learn more about how these natural opioids work. This might lead to new therapies for conditions like depression, anxiety, and chronic pain.

Objective:

To determine how opioids affect how pleasant or unpleasant it feels when the skin is touched, compressed, or heated.

Eligibility:

Healthy right-handed adults ages 18-50.

Design:

Participants will be screened under another protocol.

Participants will have 2 study visits with the same procedures, at least 1 day apart. Each visit will last 3-4 hours.

Participants will wear shorts or change into scrubs so researchers can test on their legs.

Participants will answer questions and have urine tests.

Participants will have a brain magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil will be placed over the head.

During MRI, participants will have sensory testing. They will get several types of touch to the calf of the leg. These include gentle brushing of the skin, gentle compression of the calf with an inflation sleeve, and heat stimuli.

Participants will have an intravenous line placed each day. They will get naloxone 1 day and saline the other day. Participants will not be told which they get. Naloxone is a drug that blocks opioid receptors.

The MRI and sensory testing will then be repeated.

After each stimuli block, participants will rate the sensations as well as their mood and calmness/anxiety.

Conditions

• Pain
• Touch

Interventions

OTHER

Placebo

saline

DRUG

Naloxone

We will be using naloxone at normal clinical doses as the study drug. Naloxone is an opiate antagonist and has been used since the 1960 s to reverse the effects of opiate overdoses.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  lead NIH

Principal Investigators

• Catherine Bushnell, Ph.D. · National Center for Complementary and Integrative Health (NCCIH)

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2018-10-31

Completion

2018-10-31

FDA Drug

Yes

Countries

• United States

Study Locations