Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01863186 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
A Phase 3 study, sponsored by USWM, LLC (dba US WorldMeds).
- Completed
- Registry status
- Phase 3
- Development phase
- 603
- Enrollment target
NCT01863186 is a Phase 3 study that has completed, run by USWM, LLC (dba US WorldMeds). The registered enrollment target is 603 participants.
The verdict
NCT01863186, a Phase 3 study, has completed, sponsored by USWM, LLC (dba US WorldMeds).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 603 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind treatment portion where subjects will be randomly assigned to one of three doses of study medication (2.4 mg total daily dose of lofexidine, 3.2 mg total daily dose of lofexidine, or placebo) followed by an optional open-label treatment period where subjects will be inpatient or outpatient and receive lofexidine at variable dosing for up to an additional 7 days. The Investigator hypothesizes that subjects will achieve maximum treatment effect with tolerable side effects at the 3.2 mg total daily dose and that both the 3.2 mg and 2.4 total daily doses will show better efficacy over placebo in treating symptoms of acute opioid withdrawal.
Interventions
- DRUG Placebo
- DRUG Lofexidine HCl
- DRUG Open Label Lofexidine HCL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 603 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01863186
The ClinicalTrials.gov registry entry for NCT01863186 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 603 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 3 interventions - of which Placebo is the first listed.
NCT01863186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01863186 about?
NCT01863186 is a clinical study titled "Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal". The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids. The study takes place in 2 parts: a 7-day inpatient double-blind treatment portion where subj...
What is the current status of trial NCT01863186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 603 participants. The study started on 2013-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01863186?
The interventions under investigation include: Placebo (DRUG), Lofexidine HCl (DRUG), Open Label Lofexidine HCL (DRUG).
Who is sponsoring clinical trial NCT01863186?
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.