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NCT01878006 · ClinicalTrials.gov registry record · Phase 2
Genetic Effects on Dopamine Response to an Opiate
A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT01878006 is a Phase 2 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 15 participants.
The verdict
NCT01878006, a Phase 2 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Background: \- Small differences in genes may alter responses to drugs. One gene that has different forms is the mu opioid receptor gene. People with one form of this gene are more sensitive to alcohol. People with a different form are sometimes more sensitive to pain. Morphine and other prescription pain pills produce pain relief by acting at the mu opioid receptor. Researchers want to see the effect of morphine on brain reward and subjective effects. Morphine is a strong but short-acting pain medication that is sometimes used for anesthesia during surgery. Objectives: \- To compare the effect of morphine on brain measures of dopamine release using imaging. Eligibility: \- Individuals between 21 and 55 years of age who have previously taken pain pills prescribed to treat pain from a medical or dental procedure. Design: * This study has a screening phase and a study phase. The screening phase involves one or two visits of 5 to 6 hours. The study phase consists of 4 study visits. Each study visit will take about 8 hours. * Participants will be screened with a medical and psychiatric history and physical exam. They will be asked about drinking and drug-taking history, and any family history of alcoholism or drug abuse. Blood, urine, and breath samples will be collected. * During the first study visit, an MRI scan may be performed, questionnaires completed, and a blood sample collected for genetic testing. * During study visit 2, participants will test their pain sensitivity by placing one hand in cold water. Pupil diameter will be measured after the sensitivity test. After a blood sample is taken, participants will receive the morphine or a salt solution. The sensitivity test and pupil diameter test will be repeated. Final blood samples will be collected. A brief physical exam will also be performed. * During study visits 3 and 4, participants will receive morphine or a salt solution during a PET scan. Questionnaires to assess subjective effects will be adminis
Interventions
- DRUG Placebo
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-06-13 |
| Est. Completion | 2017-04-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01878006
The ClinicalTrials.gov registry entry for NCT01878006 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01878006 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01878006 about?
NCT01878006 is a clinical study titled "Genetic Effects on Dopamine Response to an Opiate". Background: \- Small differences in genes may alter responses to drugs. One gene that has different forms is the mu opioid receptor gene. People with one form of this gene are more sensitive to alcohol. People with a different form are sometimes more sensitive to pain. Morphine and other prescripti...
What is the current status of trial NCT01878006?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2013-06-13. Estimated completion is 2017-04-27.
What interventions are being tested in trial NCT01878006?
The interventions under investigation include: Placebo (DRUG), Morphine (DRUG).
Who is sponsoring clinical trial NCT01878006?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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