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NCT01820442 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients
A Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01820442 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 30 participants.
The verdict
NCT01820442, a Phase 1 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess lofexidine related effects on QTc (an interval of the heart rhythm) in subjects receiving buprenorphine maintenance. The secondary objectives of the study are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring pharmacokinetics (amounts of drug in the blood), vital signs (heart rate and blood pressure) and adverse events (side effects) when co-administered with buprenorphine; to describe effects on opiate withdrawal when lofexidine is introduced following a 50% buprenorphine dose reduction, as required to elicit a withdrawal response; and to evaluate QTc interaction effects of lofexidine compared with placebo. The Investigators hypothesize that while lofexidine is known to prolong the QTc interval, the combination of the drugs will not create an additive effect which creates a significant safety concern. The Investigators further hypothesize that subjects will be able to tolerate the therapeutic dose of lofexidine (0.8 mg four times daily) when the buprenorphine maintenance dose is lowered to elicit withdrawal.
Interventions
- DRUG Lofexidine HCl
- DRUG Lofexidine-matching sugar pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-03 |
| Est. Completion | 2013-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01820442
The ClinicalTrials.gov registry entry for NCT01820442 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is USWM, LLC (dba US WorldMeds), which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lofexidine HCl is the first listed.
NCT01820442 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01820442 about?
NCT01820442 is a clinical study titled "Pharmacokinetic & Pharmacodynamic Interaction of Lofexidine and Buprenorphine in Buprenorphine Maintained Patients". The primary objective of this study is to assess lofexidine related effects on QTc (an interval of the heart rhythm) in subjects receiving buprenorphine maintenance. The secondary objectives of the study are to evaluate the safety and tolerability of lofexidine by evaluating and monitoring pharmacok...
What is the current status of trial NCT01820442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-03. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01820442?
The interventions under investigation include: Lofexidine HCl (DRUG), Lofexidine-matching sugar pill (DRUG).
Who is sponsoring clinical trial NCT01820442?
This trial is sponsored by USWM, LLC (dba US WorldMeds), which has 16 total clinical trials registered on ClinicalTrials.gov.
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