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NCT03096353 · ClinicalTrials.gov registry record · Early Phase 1
Sensory and Opioid Mechanisms of Affective Touch
A Early Phase 1 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 29
- Enrollment target
NCT03096353 is a Early Phase 1 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 29 participants.
The verdict
NCT03096353, a Early Phase 1 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Naloxone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2018-10-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03096353
The ClinicalTrials.gov registry entry for NCT03096353 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03096353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03096353 about?
NCT03096353 is a clinical study titled "Sensory and Opioid Mechanisms of Affective Touch". 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 ...
What is the current status of trial NCT03096353?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 29 participants. The study started on 2017-08-01. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT03096353?
The interventions under investigation include: Placebo (OTHER), Naloxone (DRUG).
Who is sponsoring clinical trial NCT03096353?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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