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NCT00027014 · ClinicalTrials.gov registry record · Phase 4
Herb-Opioid Interactions
A Phase 4 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT00027014 is a Phase 4 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 54 participants.
The verdict
NCT00027014, a Phase 4 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
Interventions
- DRUG fentanyl
- DRUG oxycodone
- DRUG St. John's Wort
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2001-09 |
| Est. Completion | 2005-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00027014
The ClinicalTrials.gov registry entry for NCT00027014 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 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 3 interventions - of which fentanyl is the first listed.
NCT00027014 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00027014 about?
NCT00027014 is a clinical study titled "Herb-Opioid Interactions". This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of...
What is the current status of trial NCT00027014?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2001-09. Estimated completion is 2005-05.
What interventions are being tested in trial NCT00027014?
The interventions under investigation include: fentanyl (DRUG), oxycodone (DRUG), St. John's Wort (DRUG).
Who is sponsoring clinical trial NCT00027014?
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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