At a glance
ClinicalIndex Comparison Record- ✓Age 18-50 years old
- ✓Right-handed on Edinburgh Handedness Inventory
- ✓Fluent in English
- ✓Able to provide written informed consent
- ✕Pregnancy or breastfeeding
- ✕Recreational drug use in past month (marijuana, MDMA, LSD, cocaine, methamphetamine, heroin, opioids)
- ✕Congenital lower limb deficiency or amputation
- ✕Peripheral neuropathy, dermatological condition (scars, burns), or tattoo in testing region within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sensory and Opioid Mechanisms of Affective Touch
In Brief
A Early Phase 1 clinical trial evaluating Placebo and Naloxone for Pain and Touch. Completed, enrolled 29 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
saline
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.