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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: Completed Phase 1 study, sponsored by USWM, LLC (dba US WorldMeds).
NCT01820442 is a Phase 1 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The ECG analysis will be conducted by a central laboratory under blinded review. QTc intervals at baseline (buprenorphine maintenance total daily dose only) will be compared to a time matched profile at each increasing lofexidine dose (as tolerated by the subjects), both before and after a withdrawal response is solicited.
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 |
What the finished NCT01820442 record still lists
NCT01820442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Lofexidine HCl is the first listed.
NCT01820442 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01820442's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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