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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: Completed Early Phase 1 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurement of brushing pleasantness using a visual analogue scale. Sensory hedonics (unpleasantness vs. pleasantness) was assessed on a scale ranging from extremely unpleasant (-100) to neutral (0), to extremely pleasant (100).
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 |
What the finished NCT03096353 record still lists
NCT03096353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03096353 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03096353's enrollment target sits among peer trials
29 927th of 2000 higher than 1,064 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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