Ignite Creation Date:
2024-05-06 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03096353
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2017-03-29
Brief Title:
Sensory and Opioid Mechanisms of Affective Touch
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Sensory and Opioid Mechanisms of Affective Touch
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 calmnessanxiety
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 calmnessanxiety
Detailed Description:
Objective Our recent pilot study found evidence suggesting that blocking endogenous opioid release increases the pleasantness associated with having the skin stroked Deep pressure touch observed in hugs and massage also typically conveys a sense of pleasantness This increased pleasantness contrasts with evidence that blocking endogenous opioid release increases pain The current study will examine the role of endogenous opioids in the pleasantness of light skin stroking and deep pressure touch and contrast it with their role in the unpleasantness of a painful heat stimulus Further it will examine the neural basis of observed perceptual changes using fMRI This study constitutes the first study of the K99 phase of a K99R00 grant application recently submitted to National Center for Complementary and Integrative Health NCCIH by Dr Laura Case
Study Population 30 healthy participants will be enrolled in the study
Design Participants will receive intravenous saline or intravenous naloxone on separate days to investigate the effect of mu-opioid antagonism on the intensity and pleasantness of superficial and deep affective touch and the intensity and unpleasantness of cutaneous heat pain Using a double-blind cross-over design functional Magnetic Resonance Imaging fMRI will be conducted during sensory testing before and after the infusion of each drug to examine the neural mediation of opioid effects on touch perception Ratings of mood anxiety pain intensity pleasantnessunpleasantness wanting and liking will also be collected throughout the study session
Outcome measures We will compare subjective ratings mood calmness anxiety pleasantness wanting liking pain intensity and unpleasantness during naloxone and saline to 1 Determine whether naloxone increases the pleasantness andor intensity of affective touch light brush and deep compression 2 Determine whether naloxone increases the unpleasantness andor intensity of cutaneous heat pain 3 Determine the role of mood or anxiety changes in mediating the effect of endogenous opioids on these perceptual measures 3 Determine changes in the brain activation related to these effects
Study Population 30 healthy participants will be enrolled in the study
Design Participants will receive intravenous saline or intravenous naloxone on separate days to investigate the effect of mu-opioid antagonism on the intensity and pleasantness of superficial and deep affective touch and the intensity and unpleasantness of cutaneous heat pain Using a double-blind cross-over design functional Magnetic Resonance Imaging fMRI will be conducted during sensory testing before and after the infusion of each drug to examine the neural mediation of opioid effects on touch perception Ratings of mood anxiety pain intensity pleasantnessunpleasantness wanting and liking will also be collected throughout the study session
Outcome measures We will compare subjective ratings mood calmness anxiety pleasantness wanting liking pain intensity and unpleasantness during naloxone and saline to 1 Determine whether naloxone increases the pleasantness andor intensity of affective touch light brush and deep compression 2 Determine whether naloxone increases the unpleasantness andor intensity of cutaneous heat pain 3 Determine the role of mood or anxiety changes in mediating the effect of endogenous opioids on these perceptual measures 3 Determine changes in the brain activation related to these effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-AT-0075 | None | None | None |