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NCT03190954 · ClinicalTrials.gov registry record · Early Phase 1
Brain Dopaminergic Signaling in Opioid Use Disorders
A Early Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 153
- Enrollment target
NCT03190954: Completed Early Phase 1 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT03190954 is a Early Phase 1 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 153 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (189% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03190954, a Early Phase 1 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
Background: The chemical messenger dopamine carries signals between brain cells. It may affect addiction. Heavy use of pain medicines called opioids may decrease the amount of dopamine available to the brain. Researchers want to study if decreased dopamine decreases self-control and increases impulsiveness. Objective: To learn more about how opiate use disorder affects dopamine in the brain. Eligibility: Adults 18-80 years old who are moderate or severe opiate users Healthy volunteers the same age Design: Participants will first be screened under another protocol. They will: * Have a physical exam * Answer questions about their medical, psychiatric, and alcohol and drug use history * Take an MRI screening questionnaire * Give blood and urine samples * Have their breath tested for alcohol Participants will have up to 3 study visits. They will have 2-3 positron emission tomography (PET) scans. A radioactive chemical will be injected for the scans. Participants will lie on a bed that slides in and out of the donut-shaped scanner. A cap or plastic mask may be placed on the head. Vital signs will be taken before and after the PET scans. Participants will get capsules of placebo or the study drug. They will rate how they feel before, during and after. Participants will have their breath and urine tested each day. Participants will have magnetic resonance imaging (MRI) scans. They will lie on a table that slides into a cylinder in a strong magnetic field. They may do tasks on a computer screen while inside the scanner. Participants will have tests of memory, attention, and thinking. Participants will wear an activity monitor for one week....
Primary Outcome
To assess whether the balance between D1R and D2R in striatum and in DA release is disrupted in participants with an opioid use disorder (OUD) who are being treated with an opioid agonist medication (MAT+), those treated with an opioid antagonist medication (naltrexone) and OUD participants who are not being treated with medications (MAT-).
Interventions
- DRUG [11C]raclopride plus drug
- DRUG [11C]NNC-112
- DRUG [11C]raclopride plus placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2017-08-17 |
| Est. Completion | 2025-10-27 |
| Phase | Early Phase 1 |
What the finished NCT03190954 record still lists
NCT03190954 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (189% higher).
The record links to 0 conditions, and to 3 interventions - of which [11C]raclopride plus drug is the first listed.
NCT03190954 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03190954 about?
NCT03190954 is a clinical study titled "Brain Dopaminergic Signaling in Opioid Use Disorders". Background: The chemical messenger dopamine carries signals between brain cells. It may affect addiction. Heavy use of pain medicines called opioids may decrease the amount of dopamine available to the brain. Researchers want to study if decreased dopamine decreases self-control and increases impul...
What is the current status of trial NCT03190954?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 153 participants. The study started on 2017-08-17. Estimated completion is 2025-10-27.
What interventions are being tested in trial NCT03190954?
The interventions under investigation include: [11C]raclopride plus drug (DRUG), [11C]NNC-112 (DRUG), [11C]raclopride plus placebo (DRUG).
Who is sponsoring clinical trial NCT03190954?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03190954's enrollment target sits among peer trials
153 97th of 2000 higher than 1,904 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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